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Zelboraf plus cobimetinib extended PFS in BRAF V600-positive melanoma
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The addition of the BRAF inhibitor vemurafenib to the MEK inhibitor cobimetinib significantly improved PFS in patients with untreated BRAF V600-positive metastatic melanoma, manufacturers Genentech and Exelixis reported.
In the randomized, double-blind phase 3 coBRIM study, 495 patients were assigned to receive either vemurafenib (Zelboraf, Genentech), at 960 mg twice daily plus placebo or vemurafenib at 960 mg twice daily plus cobimetinib at 60 mg once daily from day 1-21 of the 28-day cycle.
Sandra Horning
The study’s primary endpoint was PFS, with secondary endpoints defined as OS, objective response rate (ORR) and duration of response.
“Despite great progress in our understanding and therapy in recent years, advanced melanoma remains a difficult and deadly disease that requires more treatment options,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “These encouraging data support the potential combined use of cobimetinib with Zelboraf to block tumor growth longer than Zelboraf alone. We hope this combination therapy will lead to a new option for patients.”
Adverse events were consistent with those observed in an ongoing phase 1b clinical trial of the combination – BRIM7 – including diarrhea, non-acneiform rash, fatigue, nausea, liver laboratory test abnormality and photosensitivity/sunburn.
“These positive top-line results from coBRIM represent an important milestone for melanoma patients and their physicians, and are the first of four anticipated phase 3 pivotal trial read-outs for Exelixis-discovered compounds in 2014,” Michael M. Morrissey, PhD, president and chief executive officer of Exelixis said in a press release. “We look forward to the full presentation of the data later this year. If ultimately approved, we will execute on our collaborative U.S. co-promotion effort with Genentech and work alongside our partner to bring this important new therapeutic option to melanoma patients in need.”