Cancer Research UK reports that more than 403,000 people are diagnosed with cancer in the UK every year. Cancer is not one disease, so this page follows one strand of treatment: medicines built from peptides, or guided to the tumour by them. Neuroendocrine tumours, which carry large numbers of somatostatin receptors, are where that approach has gone furthest. A registry analysis of 63,949 neuroendocrine tumour cases, published in The Lancet Regional Health Europe in December 2022, found that age adjusted incidence rose 3.7 fold between 1995 and 2018, from 2.35 to 8.61 per 100,000.
This page keeps the latest news in one place, then covers the breakthroughs and setbacks since 2023, including the trials that failed, with the documented reason where one exists, along with trials running now and decisions still to come. The history, from the hypothalamic hormones to the first radioligand approvals and the vaccines that did not work, is on its own history page. Every statement links to a journal, registry, regulator, charity or major news outlet.
Latest news
12 October 2026
ACTION-1: the first phase 3 alpha emitter trial meets its goal
Bristol Myers Squibb announces that the phase 3 ACTION-1 trial of RYZ101, a somatostatin receptor targeting peptide carrying the alpha emitting isotope actinium 225, met its primary goal at a planned interim analysis. Progression free survival by blinded independent central review was longer than with the investigator's choice of standard care, which could be high dose long acting somatostatin analogues, everolimus or sunitinib. Everyone enrolled had grade 1 or 2 gut or pancreatic neuroendocrine tumours that had progressed after lutetium 177 radioligand treatment. The company has not released the numbers or safety data. It describes the result as the first phase 3 data for an alpha emitter based radiopharmaceutical in any cancer. The FDA granted orphan drug designation in August 2026.
7 August 2026
The FDA refuses 177Lu edotreotide, citing manufacturing
The FDA issues a complete response letter, announced by ITM on 10 August, saying it cannot approve the application for 177Lu edotreotide in its present form. The letter cites chemistry, manufacturing and controls items and matters linked to a third party commercial facility. ITM says the FDA raised no concerns about the clinical or non clinical data or about safety. The decision had been due on 28 August.
The application rested on the phase 3 COMPETE trial, published in The Lancet on 2 July 2026, in 309 people with grade 1 or 2 gut and pancreatic neuroendocrine tumours. Median progression free survival was 23.9 months against 14.1 months on everolimus, a hazard ratio of 0.67. Tumours responded in 21.9% against 4.2%, and grade 3 or 4 treatment related events occurred in 18% against 40%. Median overall survival was 63.4 against 58.7 months, a difference that was not statistically significant (hazard ratio 0.78, p = 0.206). The company intends to resubmit.
31 July 2026
Pluvicto is approved for hormone sensitive metastatic prostate cancer
The FDA approves Pluvicto with an androgen receptor pathway inhibitor for adults with PSMA positive metastatic hormone sensitive prostate cancer, according to Novartis. It is a PSMA targeting radioligand rather than a peptide, but follows the same treatment model. The approval rests on the phase 3 PSMAddition trial, which randomised 1,144 men to Pluvicto plus hormone treatment and the pathway inhibitor, or to those two alone. Radiographic progression or death occurred in 24% against 30%, a hazard ratio of 0.72 (95% confidence interval 0.58 to 0.90), with median progression free survival not reached in either arm. Interim overall survival gave a hazard ratio of 0.84 (0.63 to 1.13), not statistically significant. Grade 3 or worse side effects were 51% against 43%. The trial was published online in The Lancet on 6 August 2026.
29 May to 2 June 2026
Duravelo-2: early response rates for a bicycle toxin conjugate in bladder cancer
At the American Society of Clinical Oncology meeting, Bicycle Therapeutics reports interim results for zelenectide pevedotin, a bicycle toxin conjugate, a small constrained peptide that binds the protein Nectin-4 and carries a cell killing drug. In people with locally advanced or metastatic urothelial cancer who had already had treatment, randomised to 5 mg per square metre or 6 mg per square metre, confirmed response rates were 27.6% (2 complete and 6 partial responses) and 29.6% (3 complete and 5 partial responses). The company has agreed the 6 mg dose with regulators. In the first treatment cohort, combined with pembrolizumab, it reported encouraging response rates. Median progression free survival was not yet mature in either cohort.
Breakthroughs and setbacks since 2023
Radioligands: molecules that carry radiation to the tumour
5 June 2024
NETTER-2: radioligand as first treatment in higher grade tumours
The Lancet publishes NETTER-2, a trial of 226 people with newly diagnosed, advanced, grade 2 or 3 gut and pancreatic neuroendocrine tumours, randomised two to one to lutetium 177 dotatate with octreotide or to high dose octreotide. Median progression free survival was 22.8 months against 8.5 months, a hazard ratio of 0.276. Tumours responded in 43% against 9.3%. Overall survival results were still pending, and quality of life did not differ between the groups.
23 April 2024
Lutathera is approved for people aged 12 and over
The FDA approves lutetium 177 dotatate for children and adolescents aged 12 and over with somatostatin receptor positive gut and pancreatic neuroendocrine tumours, the first radiopharmaceutical approved for this age group. The approval rests on safety, dosimetry and pharmacokinetic data from 9 adolescents in the NETTER-P study, with efficacy extrapolated from the adult NETTER-1 trial.
28 March 2025
Pluvicto moves ahead of chemotherapy, with a survival question mark
The FDA expands the approval of Pluvicto to PSMA positive metastatic castration resistant prostate cancer before chemotherapy, after one hormone pathway drug. In PSMAfore, 468 men were randomised to the radioligand or to switching hormone drug. Radiographic progression free survival favoured the radioligand, with a hazard ratio of 0.41 at the primary analysis. Overall survival was not better in the unadjusted analysis, with a hazard ratio of 1.16 at the first reading and 0.98 at the third, and 84.2% of eligible men in the control arm crossed over to the radioligand after progression, which makes survival difficult to compare.
October 2025
Alpha emitter 212Pb DOTAMTATE: response rates in phase 2
The phase 2 ALPHAMEDIX 02 trial tests a somatostatin analogue carrying lead 212, which gives off short range alpha particles. In 35 people who had not had radioligand treatment before, 20 had confirmed partial responses, a response rate of 57.1%. In 26 people whose disease had progressed after lutetium radioligand treatment, the investigator assessed response rate was 34.6%, and 19.2% when read by a blinded central review. Both cohorts were single arm, with no comparison group. The sponsor, Sanofi with Orano Med, says the results will form the basis of discussions with regulators. It is not approved anywhere.
Peptides joined to a cell killing drug
26 February 2021 to 23 February 2024
Melflufen: approved, then withdrawn after a trial found more deaths
Melphalan flufenamide, brand name Pepaxto, a peptide drug conjugate, was given accelerated approval by the FDA on 26 February 2021 with dexamethasone for relapsed multiple myeloma. In July 2021 the FDA warned that the confirmatory OCEAN trial, against pomalidomide, showed an increased risk of death, with a hazard ratio of 1.104 for overall survival. The company withdrew it from the US market in October 2021. An advisory committee voted 14 to 2 in September 2022 that the benefit and risk was not favourable, and on 23 February 2024 the FDA issued its final decision to withdraw approval, saying the trial did not confirm clinical benefit and that the drug had not been shown to be safe or effective under its conditions of use. The European regulator has allowed use under its own authorisation.
Trying to teach the immune system with peptides
9 December 2025
GLP-1 drugs and cancer: a review of trials finds little or no effect
The Annals of Internal Medicine publishes a systematic review of 48 placebo controlled randomised trials with 94,245 participants, with a median follow up of 70 weeks. It found that GLP-1 receptor agonists and dual agonists probably have little or no effect on thyroid cancer (odds ratio 1.37, 95% confidence interval 0.82 to 2.31), pancreatic cancer (0.84), breast cancer (0.95) or kidney cancer (1.12), with moderate certainty. For several other cancers the certainty was lower. The authors note that the trials were not designed to measure cancer and that follow up was short, so longer studies are needed.
Earlier research is on the history page.
Trials running now
Results awaited
Duravelo-2: zelenectide pevedotin in bladder cancer
Bicycle Therapeutics describes Duravelo-2 as a randomised phase 2 trial of zelenectide pevedotin, alone or with pembrolizumab, in advanced urothelial cancer. Cohort 1 compares the combination with chemotherapy in people who have not been treated before. Cohort 2 tests the drug alone in people who have had at least one earlier treatment. The company says more data are planned in the second half of 2026. The registry number is NCT06225596.
Results awaited
COMPOSE: 177Lu edotreotide in higher grade neuroendocrine tumours
The phase 3 COMPOSE trial, sponsored by ITM, compares 177Lu edotreotide with the best standard treatment, capecitabine with temozolomide, everolimus or FOLFOX, in people with well differentiated grade 2 or grade 3 gut and pancreatic neuroendocrine tumours that carry somatostatin receptors. The primary measure is progression free survival. The registry lists 259 participants, shows recruitment ended in May 2025, and estimates primary completion in June 2027. The registry number is NCT04919226.
Follow up continues
Overall survival from PSMAddition and ACTION-1
Overall survival has not matured in two of the year's headline trials. In PSMAddition, the interim survival result was a hazard ratio of 0.84 with a confidence interval of 0.63 to 1.13, a positive trend that does not cross the threshold for statistical significance, and follow up for mature data is continuing. In ACTION-1, patients enrolled will continue to be followed for overall survival.
What comes next
No date announced
ITM plans to resubmit its 177Lu edotreotide application
ITM says it intends to resubmit its new drug application once the manufacturing and facility items in the FDA's letter have been addressed. No resubmission date has been announced. Its phase 3 COMPOSE trial continues.
Future medical meeting
Full ACTION-1 results and talks with the FDA
Bristol Myers Squibb says detailed ACTION-1 results will be presented at a future medical meeting and that it plans to talk to the FDA about next steps. No filing timeline has been stated.
Not yet scheduled
NICE begins looking at Pluvicto for hormone sensitive prostate cancer
NICE has opened an appraisal of lutetium 177 vipivotide tetraxetan in combination for PSMA positive hormone sensitive metastatic prostate cancer. It consulted on the draft scope, with comments closing on 20 April 2026. No guidance date had been published in the sources checked as of 5 November 2026.