Amgen said today it halted all clinical studies of its compound rilotumumab (formerly AMG 102) in advanced gastric cancer—including two Phase III studies—after the data monitoring committee for one of the trials found more deaths in the rilotumumab-plus-chemotherapy arm compared with the chemo-alone arm.
Detailed results of that trial, RILOMET-1, “will be submitted for presentation and publication,” Amgen stated, without offering details. The company did add, however, that “protocol-defined futility criteria would likely have been met at the planned interim analysis,” which was scheduled for March 2015.
“While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area,” Sean E. Harper, M.D., Amgen’s evp of research and development, said in a statement.
Amgen said it was working with investigators to coordinate study termination, and provide guidance for follow-ups of patients in the study
Rilotumumab is an investigational fully-human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF):MET pathway. That inhibition had the potential to reduce cell proliferation, impair survival signals, and prevent the migration and invasion of tumor cells, Amgen reasoned.
The apparent failure of Rilotumumab leaves the biotech giant with Phase III-or-registration cancer candidates that include:
- The immunotherapy blinatumomab, an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody indicated for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursorAcute lymphoblastic leukemia (ALL), and awaiting review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of May 19, 2015
- The experimental cancer vaccine Talimogene laherparepvec (T-Vec), an oncolytic immunotherapy derived from HSV-1 and designed to fight melanoma. Amgen is awaiting decisions on T-Vec by FDA and the European Commission. In June, Amgen said T-vec met its primary endpoint in a Phase III trial of statistically significant improvement in durable response rate (16%) with 40% of patients achieving a complete response—but narrowly missed statistical significance in a secondary endpoint of overall survival
- The investigational peptibody trebanabi, designed to inhibit the angiopoietin axis. Earlier this month, Amgen disclosed that trebanabib failed to show a statistically significant improvement in overall survival; median overall survival was 19.3 months vs. 18.3 months for the control arm in the Phase III TRINOVA-1 trial, which assessed the compound in women with recurrent platinum-resistant ovarian cancer.