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The FDA on Thursday approved the PD-L1-directed immune checkpoint inhibitor atezolizumab (Tecentriq) for advanced melanoma patients with a BRAF V600 mutation, to be used in combination with targeted agents, .

Approval was based on results of , a phase III trial of over 500 patients receiving the BRAF inhibitor vemurafenib (Zelboraf) plus the MEK inhibitor cobimetinib (Cotellic) as initial therapy, plus either atezolizumab or placebo.

Median investigator-assessed progression-free survival (PFS) reached 15.1 months for those randomized to atezolizumab, as compared with 10.6 months for those assigned to placebo (HR 0.78, 95% CI 0.63-0.97, P=0.025).

"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 at Genentech, said in a statement.

PFS favored the triplet versus the doublet at both the 12-month (54.0% vs 45.1%) and 18-month (43.6% vs 31.6%) timepoints.

Response rates were similar between the two arms (66.3% vs 65.0%, respectively), but the median duration of response was 21.0 months in the atezolizumab arm versus 12.6 months with placebo. At 1 year, 69.4% versus 50.8%, respectively, had maintained their responses.

Since the time this trial was initiated, however, standard of care for patients with BRAF-mutant melanoma has shifted to dual checkpoint blockade, followed by targeted agents at progression.

Common adverse events seen with the triplet in IMspire150 included rash, musculoskeletal pain, fatigue, and hepatotoxicity in 50% or more of patients, as well as pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction in over 20%.

The new approval marks the sixth . The drug was previously OK'd for non-small and small-cell lung cancer, triple-negative breast cancer, and urothelial and hepatocellular carcinomas.

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