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Exelixis (EXEL) and Bristol-Myers Squibb (BMY) to Present Phase 1b Data on Cobimetinib + Vemurafenib + Atezolizumab in Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma Monday October 10th

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Clinical Data Results: 14 pts who received ≥ 1 dose of A were safety and efficacy evaluable. Mediansafety follow-up was 5.6 mo (range 1.5-12.8). All-grade (G) AEs that occurred in > 20%pts and reported as related to A and/or C and/or V were nausea, fatigue, flu-likesymptoms, photosensitivity, maculopapular rash, elevated ALT/AST and bilirubin,mucosal inflammation and arthralgia. 6 pts had C- and/or V-related G3-4 AEs duringrun-in period, and 5 pts had A- and/or C- and/or V-related G3-4 AEs during the triplecombination period; all were manageable and reversible. There were no unexpectedAEs or G5 AEs. No A-related SAEs occurred. 1 pt discontinued all study treatment dueto elevated ALT/AST. 13/14 pts (93%) showed responses (RECIST v1.1), including 1CR and 12 PRs. 1 pt with PR had a 100% reduction in target lesions. Responses wereunconfirmed, and median DOR and PFS were not estimable due to limited follow-upat the time of data cut (Feb 15, 2016). 11/13 pts continue in response. Updated datawith functional biomarkers of T-cell activation will be presented.Conclusions: A + C + V combination therapy results in a manageable safety profileand promising anti-tumor activity in pts with BRAFV600-mutant metastatic melanoma.These preliminary data show that anti-PDL1 therapy can be successfully combinedwith MEK and BRAF inhibitors and warrant further exploration. NCT01656642
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Related Keywords European Society For Medical Oncology 2016, Cobimentinib, Vemurafenib, Atezolizumab, Previously Untreated Braf V600, Mutation-positive Advanced Melanoma