Interim analysis shows no improvement in overall survival
Amgen and Takeda's cancer collaboration suffered another setback yesterday after the partners decided to halt trials of ganitumab in advanced pancreatic cancer.
The companies said that they had been advised by the trial's monitoring committee to stop enrolling patients after an interim analysis of the results indicated ganitumab (AMG479) showed no improvement in overall survival.
The phase III trial - codenamed GAMMA - was looking at the effects on survival of adding ganitumab to gemcitabine in the first-line treatment of men with metastatic pancreatic adenocarcinoma.
Amgen and Takeda have also agreed to stop a phase II trial of the IGF-1 receptor-targeting antibody in locally-advanced pancreatic cancer.
"These disappointing results underscore the difficulty of treating pancreatic cancer, which remains a major unmet medical need," said Sean Harper, executive vice president of R&D at Amgen.
Gemcitabine has been the mainstay of pancreatic cancer therapy for years and there have been a string of failures among products used in combination with it, including Roche, Genentech and Chugai's Avastin (bevacizumab); Sanofi and Regeneron's aflibercept; Pfizer's axitinib; and Bristol-Myers Squibb, Lilly, ImClone Systems and Merck KGaA's Erbitux (cetuximab).
Among the only advances in treatment for the cancer have been the introduction of the FOLFIRINOX regimen - consisting of generically-available 5-FU, leucovorin, irinotecan and oxaliplatin - and positive late-stage data with Celgene's Abraxane (nab-paclitaxel) as an adjunct to gemcitabine therapy.
Ganitumab's failure is devastating to patients and a major disappointment for Amgen and Takeda's oncology portfolio after another partnered cancer drug - the VEGF receptor inhibitor motesanib - failed in a phase III trial involving patients with non-small cell lung cancer last year.
The two companies have been working closely together since 2008, when Takeda acquired the US biotech's Japanese operations along with rights to several of its pipeline drugs in the Japanese market, including already-marketed colorectal cancer Vectibix (panitumumab).
Takeda announced separately that it would terminate the Japanese arm of the GAMMA trial, which was being conducted by its Takeda Bio Development Center subsidiary.