Vemurafenib treatment in patients with BRAF-mutated melanoma failing MEK inhibition with trametinib.

Authors

null

Helen Gogas

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

Organizations

Hellenic Cooperative Oncology Group (HeCOG), Athens, Greece, University Hospital Essen, Essen, Germany, Universitätsspital Zürich - Skin Cancer Center University Hospital, Zürich, Switzerland, Department of Dermatology, University of Tübingen, Tübingen, Germany, APHP Hôpital Saint Louis, University Paris Diderot, Paris, France, Mount Vernon Cancer Centre, Northwood, United Kingdom, Royal Marsden Hospital, London, United Kingdom, Alfred Hospital, Melbourne, Australia, Gustave Roussy Institute, Villejuif, France

Research Funding

No funding sources reported

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 Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Melanoma/Skin Cancers

Track

Melanoma/Skin Cancers

Sub Track

Melanoma/Skin Cancers

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 9061)

DOI

10.1200/jco.2014.32.15_suppl.9061

Abstract #

9061

Poster Bd #

265

Abstract Disclosures