- Incyte (NASDAQ:INCY) is up 3% premarket, albeit on only 530 shares, in response to its announcement of updated results from the Phase 1 portion of a Phase 1/2 clinical trial, ECHO-202, assessing the combination of epacadostat and Merck's (MRK) Keytruda (pembrolizumab) in treatment-naive advanced/metastatic melanoma patients. The data are being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen.
- The rates of progression-free survival (PFS) in 19 patients treated with the combination were 74% (n=14/19) at Month 6 and 57% (n=11/19) at Month 12. Median PFS has not been reached. The complete response rate (CR) was 26% (n=5/19) while the objective response rate (ORR) and disease control rate (DCR) were 58% (n=11/19) and 74% (n=14/19), respectively. Median follow-up was 56+ weeks (range: 46 - 90+).
- In the total Phase 1 population (n=62), grade 3 (severe) and above treatment-related adverse events (TRAEs) were observed in 19% (n=12/62), the most common being rash (8%) and increased lipase (5%). Five patients (8%) discontinued treatment due to TRAEs. The most common (at least 15%) all-grade TRAEs were fatigue, rash, joint pain, itchy skin, diarrhea and nausea.
- Epacadostat is a small molecule inhibitor of IDO1, an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation thereby allowing cancer cells to avoid detection by the immune system. Pembrolizumab helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
- Enrollment in the Phase 2 portion is ongoing.