FDA approves Tecentriq plus Cotellic and Zelboraf for advanced melanoma
The FDA today approved atezolizumab plus cobimetinib and vemurafenib for the treatment of patients with BRAF V600-positive advanced melanoma, according to a manufacturer-issued press release.
This 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 (Tecentriq, Genentech) to the MEK inhibitor cobimetinib (Cotellic, Genentech) and BRAF inhibitor vemurafenib (Zelboraf, Genentech) prolonged median PFS (15.1 months vs. 10.6 months; HR = 0.78; 95% CI, 0.63-0.97).
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, PhD, chief medical officer and head of global product development at Genentech, said in the press release. “[This] FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”