- Median overall survival for combination 33.6 months vs 16.9 for control
- Two year overall survival was 58%
- Results selected for “Best of ASCO” program
Pierre Fabre and its partner Array BioPharma Inc. announced on 6/4/18 updated results from the Phase 3 COLUMBUS trial in BRAF-mutant advanced melanoma. The results showed median overall survival (mOS) was 33.6 months for patients treated with the combination of encorafenib and binimetinib compared with 16.9 months for patients treated with vemurafenib as a monotherapy. The combination reduced the risk of death compared with vemurafenib monotherapy (hazard ratio [HR] of 0.61 [95% CI: 0.47–0.79], p<0.0001]. The observed efficacy of vemurafenib in the control arm is also consistent with historical data, providing an additional benchmark for validating the patient population and results observed in COLUMBUS.1,2 Further, the two-year OS with the combination therapy was 58%. These results will be part of an oral presentation today at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, and have been selected for the “Best of ASCO” program.
Importantly, the presentation included data showing limited use of post-trial immunotherapy, which is consistent with other published pivotal trials of BRAF and MEK inhibitors in BRAF-mutant advanced melanoma.
“These data indicate that regardless of treatment group, the use of subsequent immunotherapies was similar, and therefore indicate that post-trial treatments are unlikely to have contributed to the OS results we’ve seen,” said Professor Reinhard Dummer, University of Zurich, lead author and Vice-Chairman of the Department of Dermatology in the University Hospital of Zürich, Switzerland. “We’re pleased to present this data at ASCO which builds upon previous analyses of the COLUMBUS data and further support our belief that encorafenib and binimetinib could be a promising new treatment option for patients with BRAF-mutant advanced melanoma.”
Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial and the Phase 3 BEACON CRC trial.
Pierre Fabre has exclusive rights to commercialize encorafenib and binimetinib in Europe, Asia, Latin America and Australia. Pierre Fabre’s development partner, Array BioPharma, has exclusive rights in the U.S. and Canada, and has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.