Overall survival (OS) is the U.S. Food and Drug Administration’s gold standard in clinical trials of cancer agents and among therapies approved for treatment of people with metastatic cancers, none have extended OS as long as 5 months. Now, for some people with metastatic melanoma, vemurafenib (Zelboraf) may be poised to shatter that ceiling.
In an open-label, phase 2 trial of patients with the BRAF V600 mutation, vemurafenib resulted in a 15.9-month median OS. According to researchers who published the study in the New England Journal of Medicine, OS in patients with metastatic melanoma treated with chemotherapy averages 7 months less than the OS observed in the vemurafenib treatment group.
An analysis is underway of OS data from the BRIM-3 study, a controlled, phase 3 trial that initially reported progression-free survival (PFS) in advance of vemurafenib’s August 2011 FDA approval.
In other notable studies involving oncologic agents: Roche reported “significant” PFS improvement in HER2-positive breast cancer patients given trastuzumab emtansine (T-DM1), a Herceptinchemotherapy single-drug combo, vs. those given lapatinib (Tykerb) and capecitabine (Xeloda). Full data will be reported later this year. Ditto for abiraterone (Zytiga), though Johnson & Johnson teased investors with topline results that showed the drug met PFS and OS endpoints when given with prednisone in chemo-naïve, castration-resistant prostate cancer patients.