Atezolizumab plus cobimetinib and vemurafenib approved for advanced melanoma

August 1, 2020 0 By FM

The FDA has recently approved atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of patients with BRAF V600-positive advanced melanoma, announced Roche.

The approval was based, in part, on data from the phase 3 IMspire150 study, which included 514 treatment-naive patients with unresectable stage IIIC or stage IV melanoma and BRAF V600 mutations.

Results showed the addition of the PD-L1 inhibitor atezolizumab to the MEK inhibitor cobimetinib and BRAF inhibitor vemurafenib prolonged median progression-free survival (15.1 months vs. 10.6 months).

Common treatment-related adverse events in the atezolizumab-cobimetinib-vemurafenib and cobimetinib-vemurafenib groups included blood creatinine phosphokinase increase (51.3% vs. 44.8%), rash (40.9% in both), arthralgia (39.1% vs. 28.1%), pyrexia (38.7% vs. 26%), alanine aminotransferase increase (33.9% vs. 22.8%) and lipase increase (32.2% vs. 27.4%).

“When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” Levi Garraway, MD, Ph D chief medical officer and head of global product development at Genentech, said in the press release.