Some of the most eagerly awaited data at this year's ASCO meeting were clinical results from the phase 3 combination study of New York–based Bristol-Myers Squibb's (BMS) human IgG4 anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) Opdivo (nivolumab) together with the anti-cytotoxic T-lymphocyte antigen 4 human IgG1κ mAb Yervoy (ipilimumab) for the treatment of first-line unresectable or metastatic melanoma. The median progression-free survival (PFS) was 2.9 months with Yervoy, 6.9 months with Opdivo and 11.5 months with the combination. “Although Opdivo doubles the PFS versus Yervoy, the combination is almost quadruple the median PFS versus Yervoy,” Fouad Namouni, vice president and development lead for immuno-oncology at BMS, said during an analyst meeting at ASCO. There were no drug-related deaths in the study, CheckMate-067, but the combination did increase the number of serious toxicities seen with either monotherapy alone.
Other results of combinations were less impressive, however. Basel-based Roche presented its phase 3 “coBRIM” study of the BRAF inhibitor Zelboraf (vemurafenib) plus the investigational mitogen-activated protein kinase kinase (MEK) inhibitor cobimetinib in patients with previously untreated BRAF V600 mutation-positive advanced melanoma. The combination led to 12.3 months PFS versus 7.2 months for patients on Zelboraf alone. And London-headquartered AstraZeneca's earlier-stage trial of the anti-programmed-death ligand 1 (PD-L1) mAb MEDI4736 with its proprietary anti-CTLA-4 fully human IgG2 mAb tremelimumab in advanced non–small cell lung cancer gave the company enough confidence to announce it would test the combo in a phase 3 trial, despite 20 out of 102 patients discontinuing the trial due to drug-related adverse events.
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