CAR-T clinical trials for Neuroendocrine Cancer

CAR-T clinical trials for Neuroendocrine Cancer

Clinical Trials, Treatment
What is CAR-T? CAR-T – chimeric antigen receptor T-cell – therapy is specifically developed for each individual patient and involves reprogramming the patient’s own immune system cells which are then used to target their cancer., i.e. it's an immunotherapy. It is a highly complex and potentially risky treatment but it has been shown in trials to cure some patients, even those with quite advanced cancers and where other available treatments have failed. The treatment involves several steps over a number of weeks. First the patient’s blood is taken and is sent off to the manufacturer’s laboratory. Here the patient’s blood is ‘trained’ to fight the cancer cells. The CAR-T blood is then transported back to the hospital and the patient is administered with the CAR-T to treat their condition. It has not…
Read More
In the land of small tumours, there is still a lot of work to do!

In the land of small tumours, there is still a lot of work to do!

Awareness, Clinical Trials, Patient Advocacy, Treatment
I like reading the words of Dr Mark Lewis, an Oncologist and a Neuroendocrine Tumour (NET) patient himself (with MEN1).  He always delivers with "enthusiastic vigour", a term he reduces to "brio" which I then googled!His article as usual sets a scene and he has form for looking back in the history of NETs. I'm sure he does this as it can often illustrate just how much clinical progress has been made since way back then. And that is the purpose of the recent article entitled "Continuing the Odyssey in the Land of Small Tumors".  He quotes from a 1987 article written by Dr Charles Moertel entitled "An Odyssey in the Land of Small Tumors" and I suspect he selected this article from Dr Moertel as he too writes with "brio"."Patients…
Read More
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE)

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE)

Clinical Trials
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - (COMPOSE) is a new trial commencing September 2021. [caption id="attachment_26806" align="aligncenter" width="846"] Graphic courtesy of ITM - clinical trial sites as at 14 Oct 2021[/caption] Brief Summary of the COMPOSE trial: This is an Open-label, Multicentre Study. Its purpose is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.  So this trial is focused on more aggressive tumours, which is great news. The clinical trials document is here.  (not fully populated yet as…
Read More
New Clinical Trial – Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

New Clinical Trial – Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Clinical Trials
When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included.  When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative.  Clearly there’s highly complex reasons why NETs react differently in different parts of the body.  I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above.  The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide).  That is not to say BP NET patients cannot get access to these treatments, I…
Read More
The GRAIL multi-cancer early detection test study

The GRAIL multi-cancer early detection test study

Clinical Trials
  Edit 13th Aug 2021.  Major Announcement from UK.  The NHS will today launch the world’s largest trial of a revolutionary new blood test that can detect more than 50 types of cancer before symptoms appear. The first people to take part will have blood samples taken at mobile testing clinics in retail parks and other convenient community locations. The Galleri(tm) test checks for the earliest signs of cancer in the blood and the NHS-Galleri trial, the first of its kind, aims to recruit 140,000 volunteers in eight areas of England to see how well the test works in the NHS. Read more here.  "The earlier that cancer can be found, the higher the chance of successful treatment and survival. Yet, too often cancer goes undetected until it has progressed…
Read More
Neuroendocrine Tumors: Targeted Therapies – Update from NET Specialist Diane Reidy-Lagunes, MD, Memorial Sloan-Kettering Cancer Center – August 2021

Neuroendocrine Tumors: Targeted Therapies – Update from NET Specialist Diane Reidy-Lagunes, MD, Memorial Sloan-Kettering Cancer Center – August 2021

Clinical Trials, Patient Advocacy, Survivorship, Treatment
Background.  For those who want a quick run through of Neuroendocrine Tumors from diagnosis to selection of treatment, about the treatments themselves plus what is the Future Directions in the Management of Neuroendocrine Tumors.  There are 8 episodes, and each is around 3-5 minutes long. I personally found them very useful and in a language understandable to patients. Great job by OncLive and Dr Reidy-Lagunes! Episode 1 - Understanding the Diagnosis and Prognosis of Neuroendocrine Tumors Diane Reidy-Lagunes, MD, provides an overview of neuroendocrine tumors, along with specific considerations for optimal diagnosis and prognostication. Understanding the Diagnosis and Prognosis of Neuroendocrine Tumors (onclive.com) Episode 2 - Neuroendocrine Tumor Pathogenesis and Molecular Testing Expert insight on the pathogenesis of neuroendocrine tumors and the best use of molecular testing to inform treatment decisions.…
Read More
Every picture tells a story (point, click, read)

Every picture tells a story (point, click, read)

Awareness, Clinical Trials, Diet and Nutrition, Inspiration, Living with Neuroendocrine Cancer, Newsletters, Patient Advocacy, Survivorship, Treatment
I always try to use graphics for a number of pictures, I admit mainly to catch people's attention but also because sometimes a picture on its own tells a story or at least provides a great introduction to one. If the picture catches your eye, clicking on will take you to the text.  This post will auto update as new blogs are published. thanks for reading and sharing!  Click here to join my private Facebook group Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Thanks for reading.RonnyI’m also active on Facebook. Like my page for even more news. Help me build up my new site here – click here and ‘Like’Sign up for my newsletters -  Click Here DisclaimerMy Diagnosis and Treatment…
Read More
Clinical Trial: Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

Clinical Trial: Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email What are cancer vaccines? I remember seeing a comment by a NET Specialist on twitter saying, "We need vaccines".  This was in response to a tweet from another NET Specialist reporting dismal data from an immunotherapy drug for Neuroendocrine Carcinomas. In 2020/2021, the word vaccine has been used a lot, but this specialist was not inferring anti-viral treatment, he was talking about "cancer vaccines", an emerging discipline in science where vaccines act as an immunostimulant to treat cancer.  This prompted me to look around and found this trial which may be of interest to you.  However, before anyone gets too excited, this is very early days in the study of…
Read More
Neuroendocrine Tumour (VMT-𝛼-NET) programs

Neuroendocrine Tumour (VMT-𝛼-NET) programs

Clinical Trials
UPDATE 10 SEP 2021.Viewpoint Molecular Targeting(TM) Receives FDA Clearance of Investigational New Drug Application for Phase 1 Imaging Study for VMT-a-NET for Neuroendocrine Tumors3 years ago, I wrote about an emerging type of peptide receptor radionuclide therapy (PRRT) suggesting it could be next generation.  That work continues.  It was being labelled with the term "Targeted Alpha-emitter Therapy (TAT)" using "alpha particles".  The current approved types of PRRT use beta particles so is a totally different method.  You might be thinking what the differences are and how does it affect me?  You can read more in my article PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT).I also wrote about the term THERANOSTICS, a combo term for THERAPY and DIAGNOSTICS.  In the same way that you have a theranostic pair in…
Read More
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumours

Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumours

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email For some time now, I've been watching the development of PET scans for Neuroendocrine Neoplasms (NENs).  I use the term 'Neoplasms' because there are different strategies for well and poorly differentiated types, Neuroendocrine Tumour (NET) and Neuroendocrine Carcinoma (NEC) respectively.It's known that most NETs have somatostatin receptors which makes tumours be seen better on somatostatin receptor-based imaging e.g. 68Ga-DOTATATE or 64Cu DOTATATE, but more aggressive types tend not to have working somatostatin receptors and are better seen on regular PET, i.e. 18F-FDG PET/CT.   However, nothing in NENs is simple and there's always outliers.  This has been highlighted since the addition of a Grade 3 Well Differentiated NET into the equation.The…
Read More
A Diagnostic Imaging Study of 64Cu-SARTATE™ for Neuroendocrine Tumours

A Diagnostic Imaging Study of 64Cu-SARTATE™ for Neuroendocrine Tumours

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email We probably should start to use the term "Somatostatin Receptor PET" (SSTR PET) a bit more.  We got used to using the term Ga68 PET but since then we have an approved copper version known as 64Cu Dotatate (commercial brand name in US DETECTNET™).  Now we have another in the clinical trial pipeline and will add others as they come onto my radar.Ga68 Dotatate/TOC/NOC - click hereCu64 Dotatate (DetectNET) - click hereA Diagnostic Imaging Study of 64Cu-SARTATE™ Using Positron Emission Tomography (PET) on Patients With Known or Suspected NETsReference: NCT04438304Trial status: RecruitingThe purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic…
Read More
Lanreotide and Keytruda – the PLANET study (NCT03043664)

Lanreotide and Keytruda – the PLANET study (NCT03043664)

Clinical Trials, Patient Advocacy
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Headline:  Roughly 40% of patients with advanced, progressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with pembrolizumab (Keytruda) in combination with lanreotide (Somulatine Depot) achieved stable disease, according to results from the phase 1b/2 PLANET clinical trial presented during the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.I've written about Pembrolizumab (Keytruda) before in my general immunotherapy coverage - click here.  I did note they weren't really having much luck with Neuroendocrine Neoplasms although I do see some success (.... but not enough) in poorly differentiated carcinomas.  Well differentiated NETs remain an immunological desert.  However, this poster abstract from ASCO GI conference caught my eye.“Pembrolizumab has antitumor activity in a…
Read More
Genome methylation accurately predicts neuroendocrine tumor origin – finding Neuroendocrine Neoplasms of unknown primary

Genome methylation accurately predicts neuroendocrine tumor origin – finding Neuroendocrine Neoplasms of unknown primary

Clinical Trials, Patient Advocacy
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email It's estimated that around 5-10% of Neuroendocrine Neoplasms (NENs) have an unknown primary - what that means is cancer cells have been found in the body but the place the cancer began remains unknown.  I wrote about this issue in more depth in my article "Needle in a haystack" - you can read that here.  In that article you will note that NET specialists through their knowledge and understanding of the behaviour of these comped tumours, can often drill down and gather various pieces of evidence to help narrow down the primary location. However, this new study would indicate they could have access to a new tool to be able…
Read More
Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Clinical Trials
When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included.  When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative.  Clearly there's highly complex reasons why NETs react differently in different parts of the body.  I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above.  The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide).  That is not to say BP NET patients cannot get access to these treatments,…
Read More
Selecting patients and the Challenges of Evaluating Response to PRRT in GEPNETs: The Present and the Future

Selecting patients and the Challenges of Evaluating Response to PRRT in GEPNETs: The Present and the Future

Clinical Trials, Patient Advocacy, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Fascinating article from the Italian NET scientific community.  This article is more than just what the title says, it provides overviews on many facets of NETs including markers, scans and PRRT itself. It covers how to select patients for PRRT in the first place, i.e. who is most likely to get a good response to this treatment and then look at how to track and assess that response. The important thing I gathered from reading is that none of this is a precise science, there are too many variables.  And while this article focusses on the clinical factors, there can of course be non-clinical factors in play in different countries…
Read More
Clinical Trial: Phase II CLARINET FORTE Somatuline Autogel (Lanreotide) increased dosing frequency

Clinical Trial: Phase II CLARINET FORTE Somatuline Autogel (Lanreotide) increased dosing frequency

Clinical Trials, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email CLARINET FORTE is a prospective single-arm, open-label, exploratory, international Phase II study to explore the efficacy and safety of an increased Somatuline® Autogel® (lanreotide) dosing frequency (120 mg every 14 days) in patients with metastatic or locally advanced unresectable pancreatic NETs or midgut NETs, with centrally-accessed progression within the last two years while on a standard lanreotide regimen (120 mg every 28 days) for more than 24 weeks. Data announced in September 2020 at the 2020 European Society for Medical Oncology (ESMO), indicated the phase 2 results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatments. This…
Read More
Clinical Trial (Phase 1 Study) of Tidutamab in Neuroendocrine Tumors (DUET-1)

Clinical Trial (Phase 1 Study) of Tidutamab in Neuroendocrine Tumors (DUET-1)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Xencor, a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, today announced that initial data from its ongoing Phase 1 dose-escalation study of tidutamab (XmAb®18087), an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors (NETs) will be presented during the upcoming North American Neuroendocrine Tumor Society’s 2020 Multidisciplinary NET Medical Virtual Symposium. About Tidutamab Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells, i.e. they…
Read More
The NETest® – a Chromogranin A replacement and more?

The NETest® – a Chromogranin A replacement and more?

Clinical Trials, Patient Advocacy
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Tumour Markers GeneralFor some years the gold standard tumour marker for Neuroendocrine Neoplasms (NENs) has been and remains today, Chromogranin A (and for certain scenarios Chromogranin B and C can provide some additional clues).  Pancreastatin, which is actually a molecule of Chromogranin A, is another marker touted but appears to be limited to USA. Its main advantage is the ability to better handle the effects of Proton Pump Inhibitor (PPI) use which is prevalent in the general population.  As we move to a new era of molecular/genetic tumour markers, there's a danger that NENs will be left behind, stuck with diagnostic tools not capable of meeting new demands. I see a…
Read More
SSTR PET – Ga68-DOTA-JR11 vs Ga68-DOTATATE

SSTR PET – Ga68-DOTA-JR11 vs Ga68-DOTATATE

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Headline - 68Ga-DOTA-JR11 was found to detect significantly more liver lesions than 68Ga-DOTATATE; however, 68Ga-DOTATATE detected more bone lesions than 68Ga-DOTA-JR11.Although it had been in trial use for some years in Europe and elsewhere, the formal approval of 68Ga-DOTATATE has led to an increase in the development of other radionuclides, some in conjunction with therapeutic options (i.e. PRRT) making a 'theranostic' approach to diagnosing, treating and surveillance Neuroendocrine Cancer patients with somatostatin receptor positive tumours.  I also wrote last year about another option called 64Cu, something already available in Europe, in particular Denmark.In another development which has been running for some time, a Ga68 variant called 68Ga-DOTA-JR11 has been in trial…
Read More
Targeted Therapy for Neuroendocrine Cancer – Sunitinib (Sutent)

Targeted Therapy for Neuroendocrine Cancer – Sunitinib (Sutent)

Clinical Trials, Treatment
Click here to see the A to Z of Neuroendocrine Cancer What is Sunitinib (Sutent)? Manufactured by Pfizer, this is a targeted biological therapy or more accurately, a multitargeted tyrosine kinase inhibitor (TKI).  You may also see it described as an anti-angiogenic agent on the basis that these tumor types are highly vascularized and show high expression of something called vascular endothelial growth factor (VEGF), a key driver of angiogenesis in neuroendocrine tumors. Because NETs are generally hypervascularized tumors, treatment with antiangiogenic drugs seems a rational approach. A complex process but in the simplest of terms, sunitinib blocks a particular enzyme and keeps tumors from making their own blood vessels, which are needed to deliver oxygen and other nutrients to help them survive and grow. In clinical trials, SUTENT was…
Read More
Targeted Therapy for Neuroendocrine Cancer – Everolimus (Afinitor)

Targeted Therapy for Neuroendocrine Cancer – Everolimus (Afinitor)

Clinical Trials, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Click picture to read the A to Z of Neuroendocrine Cancer What is Everolimus (Afinitor)? Manufactured by Novartis, this is a targeted biological therapy or more accurately, a mammalian Target of Rapamycin (mTOR) inhibitor. It works by stopping some of the signals within cells that make them grow and divide. Everolimus stops a particular protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. So everolimus helps to stop the cancer growing or may slow it down.  The drug is also approved for Renal Cell Carcinoma (RCC) and hormone-receptor-positive advanced Breast Cancer.The drug is administered in oral form (tablet). The recommended dose for AFINITOR®…
Read More
My interview with ITM – I’m still here!

My interview with ITM – I’m still here!

Awareness, Clinical Trials, Patient Advocacy
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email I was delighted to be contacted by ITM AG, a Germany based pharmaceutical company specialising in targeted radionuclide technology in precision oncology (e.g. Peptide Receptor Radionuclide Therapy - PRRT).  The company is formally known as  ITM Isotopen Technologien München.One of their pipeline developments is 177Lu-Edotreotide / Solucin® in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET).  The development is via the COMPETE Phase III Clinical Trial which is being conducted worldwide in 11 countries at 33 sites and is open for recruitment.  I actually wrote about this trial after attending a workshop at the annual ENETS conference in 2018.I was delighted when they wanted to interview me to…
Read More
Clinical Trial:  Lu-177 DOTATOC (PRRT) in adult subjects with Somatostatin receptor (SSTR) positive Pulmonary, Pheochromocytoma, Paraganglioma,  Unknown primary, and Thymic Neuroendocrine Tumors

Clinical Trial: Lu-177 DOTATOC (PRRT) in adult subjects with Somatostatin receptor (SSTR) positive Pulmonary, Pheochromocytoma, Paraganglioma,  Unknown primary, and Thymic Neuroendocrine Tumors

Clinical Trials
Excellent news for those who don't have Gastroenteropancreatic NETs (GEP-NETs). A trial of PRRT is being set-up for the less common types of NET including those with an unknown primary.  Using the DOTATOC radionuclide rather than the Lutathera model of using DOTATATE, this trial will cater for Pulmonary, Pheochromoctyoma, Paraganlioma, Unknown Primary and Thymic Neuroendocrine Tumours.Excel Diagnostics and Nuclear Oncology Center (EDNOC) announced today that its physician sponsored Investigational New Drug (IND) application to evaluate safety and efficacy of Lu-177 DOTATOC in adult subjects with Somatostatin receptor (SSTR)  expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymic Neuroendocrine Tumors (PUT-NET),  has received approval to proceed by USA Food and Drug Administration (FDA) and also charge authorization has been granted (IND#143631, NCT04276597). This IND is anticipated to start enrolling patients by early…
Read More
Oral Octreotide using RaniPill™

Oral Octreotide using RaniPill™

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Credit: Rani Therapeutics Update 4th May 2021According to Fierce Biotech, Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream.The pill aims to make it easier for a patient to take therapies that typically require an injection or infusion, including treatments for diabetes, arthritis and other diseases.Currently, the Fierce 15 winner is working with drugmakers Novartis and Takeda to transform their liquid injections into solid pillsRani Therapeutics, a leader in oral biologics, has announced positive results from the Phase…
Read More
NETDetect: Earlier diagnosis of Neuroendocrine Cancer gets a boost

NETDetect: Earlier diagnosis of Neuroendocrine Cancer gets a boost

Clinical Trials
[caption id="attachment_16474" width="640" align="aligncenter"] Dr Eugene Woltering - NET Specialist[/caption] It's well known that Neuroendocrine Cancer is difficult to detect and as a consequence, many people are not diagnosed until late stages. The difficulty in detection is not just focussed on the complexity of the disease but also the lack of understanding within the medical community who don't always see sufficient evidence to refer the person on to receive expensive testing and in some cases confirmatory and expensive imaging which may not show small tumours. Currently, there's no screening test for Neuroendocrine Cancer for the simple fact that it's not a high population disease and it's not a known killer. This development from well known NET Specialist Dr Eugene Woltering could help bridge that gap although some suspicion to utilise…
Read More
Clinical Trials – PEN-221 for Neuroendocrine Cancer

Clinical Trials – PEN-221 for Neuroendocrine Cancer

Clinical Trials
What is PEN-221?Tarveda Therapeutics is discovering and developing a new class of potent and selective precision oncology medicines for the treatment of patients with various solid tumor malignancies. Their strategy includes developing their own proprietary Pentarin miniature conjugates to enhance the effectiveness of promising anti-cancer payloads that have struggled without their selective targeting to solid tumors.  These medicines are known as 'Pentarins'. PEN-221 is the lead candidate 'Pentarin' aimed at Neuroendocrine Cancer - PEN-221.Somatostatin receptor 2 (SSTR2) is frequently overexpressed on several types of solid tumors, including neuroendocrine tumors and small-cell lung cancer. Peptide agonists of SSTR2 are rapidly internalized upon binding to the receptor and linking a toxic payload to an SSTR2 agonist is a potential method to kill SSTR2-expressing tumor cells. PEN-221 is a conjugate consisting of microtubule-targeting…
Read More
Clinical Trials – ONC201 for Neuroendocrine Cancer (including Pheo/Para)

Clinical Trials – ONC201 for Neuroendocrine Cancer (including Pheo/Para)

Clinical Trials
What is ONC201? A company called Oncoceutics is developing a novel class of safe and effective cancer therapies called imipridones. Imipridones have a unique three-ring core structure and selectively target G protein-coupled receptors (GPCRs), the largest class of membrane receptors and a common target of approved drugs that are underexploited in oncology. Despite being historically uncommon as targets in oncology, GPCRs control an array of critical prosurvival and stress signaling pathways that are often dysregulated in human cancer to favor cancer cell survival and propagation. The ability of imipridones to target GPCRs with a high degree of selectivity represents a novel opportunity in oncology that generates remarkably safe and effective therapeutics. ONC201, the founding member of this novel class of therapies, is an orally active, safe, and selective antagonist of…
Read More
Clinical Trials – Surufatinib for Neuroendocrine Cancer

Clinical Trials – Surufatinib for Neuroendocrine Cancer

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email What is Surufatinib?Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.Update:  July 1st 2021. Hutchmed announces that the FDA has accepted its filing of the New Drug Application (NDA) for surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors (NETs).The PDUFA goal date assigned by the FDA is April 30,…
Read More
Clinical Trials of PV-10 (Rose Bengal) for the treatment of Neuroendocrine Tumours (NET)

Clinical Trials of PV-10 (Rose Bengal) for the treatment of Neuroendocrine Tumours (NET)

Clinical Trials
Reviewed and edited 26th September 2021 Updated September 21st 2021 Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at European Society for Medical Oncology (ESMO) Congress 2021 KNOXVILLE, TN, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the European Society for Medical Oncology (ESMO) Congress, held online from September 16-21, 2021. Highlights from the ESMO 2021mNET Presentation: Baseline disease characteristics N = 12 patients: 50% male; median age of 66 years (range 47-79) Primary tumor sites: 7…
Read More
New Radiotracer Can Identify Nearly 30 Types of Cancer – SNMMI – 68Ga-FAPI PET/CT

New Radiotracer Can Identify Nearly 30 Types of Cancer – SNMMI – 68Ga-FAPI PET/CT

Clinical Trials, Living with Neuroendocrine Cancer
[caption id="attachment_15259" align="aligncenter" width="840"] see citation below[/caption] New radiotracer can identify nearly 30 types of cancer (including NETs). Future potential for therapeutic application. This is a different type of radiotracer being currently being used in the approved market for NETs.  It's availability and timeline is not yet known. Date: June 7, 2019 Source: Society of Nuclear Medicine and Molecular Imaging Summary: A novel class of radiopharmaceuticals has proven effective in non-invasively identifying nearly 30 types of malignant tumors. Using 68Ga-FAPI PET/CT, researchers were able to image the tumors with very high uptake and image contrast, paving the way for new applications in tumor characterization, staging and therapy. Red more here. https://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=31744 Watch this space for more data on availability timeline and what type of NETs were used in the trial…
Read More
LUTATHERA (PRRT) – NETTER 2 Clinical Trial for Grade 2/Grade 3 Neuroendocrine Neoplasms

LUTATHERA (PRRT) – NETTER 2 Clinical Trial for Grade 2/Grade 3 Neuroendocrine Neoplasms

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Brief SummaryThe NETTER-1 trials led to the approval of Lu177 (or Lutathera), more commonly known in the community as Peptide Receptor Radio Therapy (PRRT).  This led to an explosion of availability across the world but many gaps in service remain.Many PRRT spin off trials are in the pipeline looking at different types of PRRT, mainly using slightly different radionuclides and techniques.  However, NETTER-2 builds on the success of the approved version formally known as Lutathera.The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to…
Read More
Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

Clinical Trials
Update as at 31st July 2021.Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumours.  They have a lead molecule, paltusotine (also referred to as CRN01941 for NET and more recently as CRN00808 for Acromegaly and NET), that may turn out to be best in class. Phase 2 testing for Acromegaly is on track to be completed in Q4 2020. Phase 3 trial likely in 2021 and if successful, they are hoping for FDA approval in 2023 (although the impact of COVID may move these dates to the right).  But it is already behind…
Read More
Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trials
I was never diagnosed with Irritable Bowel Syndrome (IBS) but sometimes I feel like I now have it.  I know many others feel the same way.  But when I look at the alternatives, I can't help thinking it's a small price to pay given that one of them might be a slow degrading quality of life until shuffling off  this mortal coil. If I had the choice again, I would still take the surgery. Before the article continues, let me be clear - I'm not suggesting this is a potential treatment for NET patients with post abdominal surgery side effects or side effects of any other treatment, nor am I suggesting it's a potential treatment for those with carcinoid syndrome diarrhea.  I publish it because there is a connection to…
Read More
Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email "Interestingly, the ORR in pancreatic NETs was 44%, a rate not seen before with targeted agents," Jonathan Strosberg, MD, head of the neuroendocrine tumor division at Moffitt Cancer Center in Tampa Tweet Lenvatinib has completed a Phase 2 trial in Gastrointestinal (GI) and Pancreatic Neuroendocrine Tumours.  The trial was sponsored by Grupo Espanol de Tumores Neuroendocrinos (Spanish NET scientific organisation) and the manufacturers.  A European venture with sites in Austria, Italy, Spain, UK.   Headline: The responses are better than Everolimus (Afinitor) and Sunitinib (Sutent).What is Lenvatinib?It is a type of targeted therapy known as a multikinase inhibitor. The brand name is 'LENVIMA'. These work by inhibiting multiple intracellular and…
Read More
Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email The treatment of liver metastasis is a common approach following a metastatic diagnosis or discovery of liver metastasis downstream via re-staging. In addition to surgery, there are several liver directed therapies available via embolization techniques. This comes in several flavours:1. Bland liver embolization - a minimally invasive technique which simply blocks the blood supply to the liver tumours in an attempt to reduce or kill those tumours. Sometimes called Hepatic Arterial Embolization or HAE.2. Chemotherapy liver embolization - as above but adds in some cytotoxic chemo to the mix. Sometimes called Trans Arterial Chemo Embolization or TACE.3. Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to…
Read More
Clinical Trial SPARTALIZUMAB  – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trial SPARTALIZUMAB – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trials, Treatment
PDR001 (anti-PD-1) is an investigational immunotherapy being developed by Novartis to treat both solid tumors and lymphomas (cancers of the blood).  It is currently being trialled on many cancers including Neuroendocrine.  It's brand name is SPARTLIZUMAB. How PDR001 works PDR001 is a type of immunotherapy, meaning that it acts by activating the body’s own immune system to recognize and fight cancer cells. Normally, an immune system cell called T-cells recognizes and kills infected or abnormal cells, including those that are cancerous. To prevent T-cells from accidentally damaging healthy and essential tissues, however several immune system checkpoints exist to inhibit, or block, them from going about this work. One example is the programmed cell death 1 (PD-1) pathway. Healthy cells produce and display a protein called programmed cell death ligand-1 or…
Read More
Breath test with the goal of detecting multiple cancers – ready to start trials

Breath test with the goal of detecting multiple cancers – ready to start trials

Clinical Trials
While it's a long way off becoming reality, this is quite an exciting clinical trial. I have no idea if it will pick up Neuroendocrine disease but initially, patients with suspected oesophageal and stomach cancers will be asked to try the test. Later it will be extended to include prostate, kidney, bladder, liver and pancreatic cancers. It's possible that Neuroendcorine tumours in these locations might be picked up or at least show up some abnormality that triggers further checks. The fact that Cancer Research UK is involved gives me some confidence as they tend to back the strong horses. I will keep this article live and track developments. Read more by clicking here. Thanks for reading Ronny I’m also active on Facebook. Like my page for even more news. I’m also…
Read More
Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Clinical Trials, Living with Neuroendocrine Cancer, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email UPDATE: In March 2020, the decision was taken to terminate further in-house development of the MTD201 programme with immediate effect although the asset remains available for licensing. All activities connected with MTD201 have been wound down expeditiously and the manufacturing facilities in Bilbao have been closed. Following the termination of in-house development of MTD201, the Company realigned its strategy towards exploiting its Q-Sphera technology more broadly.Original Article belowIn my article listing the somatostatin analogues and their drug delivery systems pipeline (click here), there has been a very interesting development in a product called Q-Sphera (was previously known as Q-Octreotide).  In a press release, it was announced that an unnamed 'pharma giant'…
Read More
Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Clinical Trials
This post is currently parked due to anecdotal reports that Ipsen is withdrawing from the radiopeptide market.  It's possible this product may continue under another manufacturer.  Will update when known. What is Lutetium-177 OPS-201? This is a 'next generation' Peptide receptor radionuclide therapy (PRRT) or more specifically the radiopharmaceutical that binds to both activated and unactivated somatostatin receptors which are upregulated on these tumours. There is far higher binding via this mechanism than standard octreotate. The technical name of the radiopharmaceutical is Satoreotide tetraxetan lutetium-177 (author's note, I'm guessing but it could be a variant of Lanreotide).  It was once named JR11. What's the difference to the current approved therapy?  Conventional PRRT (e.g. Lutathera, Lu177 Dotatate) is based on a somatostatin receptor 'agonist' approach, whereas 177Lu Ops 201 Satoreotide is…
Read More
Neuroendocrine Cancer – Short Update from NANETS 2018

Neuroendocrine Cancer – Short Update from NANETS 2018

Clinical Trials, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship
I would love to go to a NANETS conference but I would need sponsorship or otherwise have to fund my own way there. Seattle sounds like a great place to visit. I would even have been their twitter correspondent had they asked! I've been to the European equivalent twice, they always have theirs in Barcelona it would seem, at least NANETS uses different locations making it more interesting.  It's a scientific conference for the most part, but I guess some basic stuff is also covered. However, in the world of instant contact and communications on the internet, together with twitter, one can keep up to speed on what is or has been discussed.  One day, NANETS and ENETS will be sufficiently advanced that we can all watch the presentations from…
Read More
Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Clinical Trials, Living with Neuroendocrine Cancer, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Edit 21st January 2021. The imaging time window of 64Cu-DOTATATE positron emission tomography/computed tomography (PET/CT) for patients with neuroendocrine neoplasms can be expanded from one hour to three hours post-injection, according to new research published in the January 2021 issue of The Journal of Nuclear Medicine.  Read more hereEdit 4th September 2020.  64Cu-dotatate now named Detectnet™ is approved for use by US FDA. Majority read revealed Detectnet had over 98% accuracy, 100% sensitivity, and over 96% specificity to confirm or exclude presence of disease. Read more here. Edit 14th July 2020.  Expanded Access Program via clinical trial now recruiting - see below.  The objective of this trial is to provide patients with confirmed…
Read More
177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors proves effective

177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors proves effective

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email In the News Update in March 2021.  Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company, announced the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE), in patients with neuroendocrine tumors (NET).  Clinical Trial number to follow.  EBTATE is used in Precision Medicine for Targeted Radionuclide Therapy. The key feature of this technology is the appendage of Evans blue (EB) to the targeting radiopharmaceutical. EB binds reversibly to serum albumin to enhance the radiotherapeutic time window with longer circulation half-life and increase…
Read More
Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Clinical Trials, Treatment
Researchers are testing the drug Sapanisertib to see if it can halt the progression of pancreatic NETs (pNETs) which cannot be surgically removed, have not responded to other treatment, and have spread to other parts of the body. What is Sapanisertib? Sapanisertib is one of a group of targeted therapy drugs that interferes with tumor progression by inhibiting an enzyme known as mTOR which a tumor cell needs for growth.  In fact this is the same technique used in Afinitor (Everolimus), already approved for NETs. It is also being tested in a number of different advanced cancers, including bladder, kidney, breast, liver, and certain types of lung cancers, among others. The Clinical Trial The primary goal of the phase II study is to evaluate how well pNET tumors respond to Sapanisertib.…
Read More
Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Updated 21st March 2021Thankful to a fellow patient for this update from Professor Essand. "The AdVince trial is actively recruiting NET patients with liver metastases. The AdVince trial is a so-called phase I dose escalation study with four dose levels and we are currently treating at dose level three (so far without observing severe toxicity). As for all phase I studies, the primary endpoint is safety and to determine maximum tolerable dose of the oncolytic AdVince virus. We are of course also looking for efficacy. We have for practical reasons so far only included local patients for the dose-escalation part (phase I). This is because of the complex treatment schedule with…
Read More
PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT)

PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email What is Targeted Alpha-emitter Therapy?  Regular PRRT which is authorised for use now, i.e. Lutathera/Lu177 is a beta therapy.  Targeted Alpha Therapy is based on the coupling of alpha particle emitting radioisotopes to tumour selective carrier molecules, such as monoclonal antibodies or peptides. These molecules have the ability to selectively target tumour cells even if they are spread throughout the body. They recognize the targeted cancer cells through antigens that are expressed on the cell surface and can bind selectively to these cells, similar a key fitting into a lock. In targeted alpha therapy these carrier molecules serve as vehicles to transport the radioisotopes to the cancer cells. This is…
Read More
Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Clinical Trials
Graphic courtesy of ITM In the News. On the heels of the approval of PRRT in USA and UK and elsewhere, here's news of a new PRRT compound undergoing a phase 3 clinical trial.  ITM Isotope Technologies Munich SE, a specialized radiopharmaceutical company, today (7th Dec 2017) announced the enrolment of the first patient recruited in Europe for the COMPETE phase III clinical trial at the University Hospital Marburg, Germany. The CEO of ITM said "This marks the starting point of COMPETE in Europe, whereby we expect a rapid increase in the number of recruits.”What is the COMPETE TRIAL? COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) and the trial is comparing it to Everolimus (Afinitor). The trial runs…
Read More
Lanreotide for Lung NETs – SPINET Clinical Trial

Lanreotide for Lung NETs – SPINET Clinical Trial

Clinical Trials, Treatment
Reviewed and updated 19th October 2021.  Phase III trial data updatedThere's been a lot of action in the area of what is termed Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs).  It can therefore sometimes appear that Lung NETs are the poor relation.  There are certainly some unmet needs in this area of the anatomy including a lack of research.  However, there has been some recent movement. Last year, the use of Afinitor (Everolimus) was approved for progressive, non-functional NET of GI or Lung origin.SPINET Trial for Lung NETsIn late 2016, I tipped you off about an Ipsen sponsored trial for Lung NETs involving Lanreotide (Somatuline).  SPINET is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of Lanreotide plus "Best Supportive Care" (BSC) versus placebo plus BSC for the treatment…
Read More
Immunotherapy: Studies with Neuroendocrine Neoplasms

Immunotherapy: Studies with Neuroendocrine Neoplasms

Clinical Trials, Treatment
IntroductionThere's a lot of Immunotherapy stuff out there! However, I also wanted to break it down and perhaps see if I can pick up the what, when, why, where and how in regard to Neuroendocrine Cancer. It's difficult, not least because the picture is not clear and there is no general roadmap printed, let alone one for Neuroendocrine disease. Immunotherapy for NETs was discussed at ENETS 2017 in Barcelona. The presentation that sticks out was one given by Dr Matthew Kulke, a well-known NET Specialist in Boston. My reaction to the presentation was one of 'expectation management' and caution i.e. it's too soon to know if we will get any success and when we will get it. He also hinted that it's more likely that any success will first be…
Read More
ASCO 2017 – Let’s talk about NETs #ASCO17

ASCO 2017 – Let’s talk about NETs #ASCO17

Clinical Trials
ASCO (American Society of Clinical Oncology) is one of the biggest cancer conferences in the world normally bringing together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.  As Neuroendorine Tumors is on a roll in terms of new treatments and continued research, we appear to be well represented with over 20 'extracts' submitted for review and display.  This is fairly complex stuff but much of it will be familiar to many.  I've filtered and extracted all the Neuroendocrine stuff into one list providing you with an easy to peruse table of contents, complete with relevant linkages if you need to read more.  For many the extract title and conclusion will be sufficiently educational or at least…
Read More
All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

Clinical Trials, Treatment
Update June 6th 2021. Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera. New analysis of the NETTER-1 trial data has been published. For those who just need a quick summary, the quote from Dr Jonothan Strosberg is below. Short PRRT PrimerWhat is Peptide Receptor Radionuclide Therapy (PRRT)?For those who are still not sure what it's all about. This is a non-surgical treatment which is normally administered intravenously. It's based on the use of somatostatin receptors to attract a 'radiopeptide'. The radiopeptide is a combination of a somatostatin analogue and a radioactive material. As we already know, somatostatin analogues (i.e. Lanreotide/Octreotide) are a NET cell targeting drug using somatostatin receptors, so when combined with radioactivity, it binds with…
Read More