Lenvatinib (LENVIMA) in Neuroendocrine Cancer — Updated January 2026
What is Lenvatinib?
Lenvatinib is a targeted therapy known as a multikinase inhibitor. The brand name is LENVIMA. These drugs work by inhibiting multiple intracellular and cell‑surface kinases involved in tumour growth, angiogenesis, and metastatic progression. Targets include:
- VEGFR
- PDGFR
- FGFR
- c‑KIT
- Flt3
Because tumour progression typically involves multiple signalling pathways rather than a single driver, multikinase inhibition is a logical therapeutic strategy.
How does it compare with other targeted therapies used in NETs?
- Sunitinib (Sutent) – a multikinase inhibitor targeting VEGF pathways; approved for pancreatic NETs.
- Everolimus (Afinitor) – an mTOR inhibitor that blocks cell growth and angiogenesis; approved for several NET types.
- Cabozantinib – a potent inhibitor of VEGFR2, MET, and AXL; now approved for pancreatic and extra‑pancreatic NETs in many countries.
Lenvatinib is already approved for thyroid, renal, and liver cancers. Its mechanism overlaps with the agents above, and combination or sequential use is common in oncology.
The TALENT Trial (GETNE 1509) — Phase 2 Results (NCT02678780)
This multicentre, open‑label Phase 2 study enrolled 111 patients with advanced, progressive Grade 1–2 pancreatic NETs (panNETs) or gastrointestinal NETs (GI‑NETs). All had progressed on prior therapy.
Key Findings
- Overall Response Rate (ORR): 29.9%
- 44.2% in panNETs
- 16.4% in GI‑NETs
- Median PFS: 15.7 months
- Duration of response:
- panNET: 19.9 months
- GI‑NET: 33.9 months
- Toxicity: Mostly mild–moderate (fatigue, diarrhoea, hypertension).
- 93.7% required dose reductions or interruptions.
This represents the highest centrally confirmed response rate reported for a targeted agent in advanced GEP‑NETs.
Publication
Capdevila et al., Journal of Clinical Oncology, 2021. DOI: 10.1200/JCO.20.03368.
What’s Next?
Given the strong response rates compared with other approved targeted agents, a Phase 3 trial would normally be expected. However:
As at January 2026, no Phase 3 trial of lenvatinib in GEP‑NETs has been announced. No regulatory submissions or sponsor‑initiated expansions have been reported.
Real‑world data published in 2025 suggests that lower starting doses (8–14 mg) may retain activity with improved tolerability, but this has not yet led to a formal Phase 3 programme.
I will continue to monitor this.
Other Clinical Trials Involving Lenvatinib
1. Lenvatinib + Everolimus (NCT03950609)
MD Anderson Cancer Center, USA
- Status: Active, not recruiting
- Updated primary completion: March 2026 (estimated)
- Purpose: Evaluate the combination in advanced, unresectable NETs
- Notes: No results posted yet
This trial has been repeatedly delayed but remains ongoing.
2. Lenvatinib + Pembrolizumab (Keytruda) (NCT03290079)
Moffitt Cancer Center, USA
- Status: Suspended
- Reason: Interim analysis showed
- insufficient tumour shrinkage for partial response
- insufficient progression to justify continuation
- Update (2026): No restart, no new data, no publications.
This programme appears unlikely to proceed further. You can read the output click here
3. Lenvatinib in Pheochromocytoma/Paraganglioma (NCT03008369)
Mayo Clinic
Earlier versions of the trial record showed 3 participants, but the final dataset confirms:
- 11 enrolled
- 9 evaluable for response
- Study completed: September 2022
- Results posted: Updated February 2024
Key Findings
- ORR: 9% (1 partial response)
- Disease Control Rate: 81%
- 1 PR
- 8 stable disease
- 2 progressive disease
- Median PFS: 14.7 months
- Median OS: Not reached
- Toxicity: Consistent with known lenvatinib profile
Although the ClinicalTrials.gov summary is poorly formatted, the data suggest modest activity with meaningful disease stabilisation in a rare tumour type with limited options.
Reference Material Used
- ESMO Congress 2018 – 1307O – Efficacy of lenvatinib in patients with advanced pancreatic (panNETs) and gastrointestinal (giNETs) grade 1/2 (G1/G2) neuroendocrine tumors: Results of the international phase II TALENT trial (GETNE 1509)
- ClinicalTrials.gov – NCT02678780 (TALENT)
- ClinicalTrials.gov – NCT03950609 (Lenvatinib + Everolimus)
- ClinicalTrials.gov – NCT03008369 (Pheo/Para)
- ClinicalTrials.gov – NCT03290079 (Lenvatinib + Keytruda)
- Journal of Clinical Oncology (2021) – Lenvatinib in Patients With Advanced Grade 1/2 Pancreatic and Gastrointestinal Neuroendocrine Tumors: Results of the Phase II TALENT Trial (GETNE1509)
- Phase II study of pembrolizumab and lenvatinib in advanced well-differentiated neuroendocrine tumors – click here
- Real-world outcomes of lower lenvatinib doses in advanced neuroendocrine tumors: a multinational retrospective study – click here
Final Thoughts
New treatments can take years to progress through trials, and many never reach approval. Not everyone will be eligible, and some trials halt early. Please keep this in mind when reading about emerging therapies. I will continue to update this page as new information becomes available.
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Finally
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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Hi, there. This is straight from the horse’s mouth: I was part of the Spain Lenvatinib trial from May 2016 to end of October 2017 (I live in Madrid). Having been diagnosed with and had surgery for locally advanced pancreatic neuroendocrince cancer in 2011, I experienced PFS till late 2015 when the beast came back in the form of liver metastasis. A first clinical trial did not work and I entered the Lenvatinib trial. I was put on the full 24 mg dose initially but this was gradually reduced and I was on the minimum 10mg by the time I exited the trial in 2017. I left as my tolerance to the toxicity had reached its limit and I could not continue with the nausea, diarrea, severe joint and muscular pain. I should add that I am very sensitive to medication. Over the 18 months I was on the trial, the cancer spots on my liver shrank considerably and my CgA levels are today almost within normal range. (I take PPIs which can skew results). I was also treated with SBRT. Since then, I have been put on Somatuline Autogel 120 and I have 3-monthly CT scans, with an Octreoscan SPECT/CT scan before Christmas. Nearly 15 months after coming off Lenvatinib I show no tumoral activity. Needless to say, I hold my breath between scans (next one in March) but know that awareness of neuroendocrine cancer has grown enormously since my initial diagnosis – thanks in part to blogs such as Ronny’s – and that this impacts research. Sad deaths such as Aretha Franklin’s also help to strengthen awareness. My oncologist tells me that should I have a relapse, then he’ll recommend PRRT. I am blessed to live in a part of the world where all this is a) available and b) available through the public health system.
Good luck to one and all and unending thanks to Ronny for keeping us up to date.
There is so much hope now in this sneaky cancer . I just want to live and live …life is so wonderful…now there is even more hope and time for us n e t s people!! Just a shame sometimes we have to shout out for it! My doctor recently scared me by calling after a 5 1ahh sample saying it was high again…I immediately brought my consultant appointment forward and worried constantly for the weeks wait….only to be told it was actually LOWER than ever before and I can now after 2 and a bit years go to 6 monthly appoint….jumping for joy was an understatement!!!
Keep it up Ronnie….you are doing a great job in reporting the latest and greatest. Liver Mets continues as the most irritating but treatable in different stages. We need more and more on this topic! Thank You!