Hellenic Cooperative Oncology Group (HeCOG), Athens, Greece
Helen Gogas , Dirk Schadendorf , Reinhard Dummer , Claus Garbe , Celeste Lebbe , Paul D. Nathan , James M. G. Larkin , Andrew Mark Haydon , Dimitris Bafaloukos , Caroline Robert
Background: Trametinib was shown to improve progression-free and overall survival in patients with metastatic melanoma with a BRAF V600E or V600K mutation as compared with chemotherapy in the METRIC trial. However, the median duration of response was 5.5 months and median progression-free survival was 4.8 months in the Trametinib group. Vemurafenib and Ipilimumab were still investigational when this trial was initiated but were available in clinical trials for post-protocol treatment. Methods: In this phase III trial 98 patients out of the 322 patients of the intent to treat population who had metastatic melanoma with a V600E or V600K mutation received Vemurafenib (960mg twice daily orally). We present data of patients with complete information on initiation and discontinuation date of Vemurafenib and investigator reported response. Results: With a median follow-up of 18.3 months, the median progression free survival (PFS) was 5.2 months with 95% CI 3.7-5.7 and a range of 0.5-27.5+ months. The 6 months PFS was 40.1%. The median overall survival (OS) was 8.3 months with 95% CI 7.1-10.6 and a range of 0.5-27.5+. The 6 months OS was 68.1%. Nineteen patients achieved a partial response and one a complete response. Conclusions: Treatment with vemurafenib had an impact on progression free survival post trametinib treatment in patients receiving a MEK inhibitor in first or second line setting. Sequencing BRAF inhibitors with MEK inhibitors and combinations are currently under investigation.
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Abstract Disclosures
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