Dive Brief:
- Incyte Corp., best known for its bone marrow disease drug Jakafi, on Wednesday said a combination of its experimental IDO1 enzyme inhibitor and Merck's Keytruda (pembrolizumab) helped shrink the tumors in 11 out of 19 patients with treatment-naive advanced melanoma.
- Median progression-free survival was not reached in the updated results from the Phase 1 study, but all responses were confirmed with a median follow-up time of 42 weeks.
- Incyte is enrolling patients for a Phase 2 tumor-specific study as part of its plan to evaluate the combination therapy across several solid tumors and hematological malignancies. A Phase 3 trial studying Keytruda with either placebo or Incyte's drug, known as epacadostat, is underway and expected to readout in 2018.
Dive Insight:
The clinical and market successes of Mercky's Keytruda and Bristol-Myers Squibb' Opdivo (nivolumab) have spurred nearly 100 combination studies pairing the PD-1 inhibitors with various other small-molecule drugs, immuno-oncology agents or vaccines, according to a report from EP Vantage.
Incyte hopes combining epacadostat with Keytruda will help boost response rates, compared to treatment with just the anti-PD1 drug alone.
The positive results, while still early, give a lift to Incyte, which has seen two clinical trials of Jakafi fail this year. In February, the Delaware-based biotech discontinued further study of Jakafi in solid tumors after a Phase 3 trial failed to demonstrate efficacy in prostate cancer, just a few weeks after a Phase 2 trial in colorectal cancer also fell short.
RBC Capital Markets analysts Simos Simeonidis sees the combination's safety data as particularly positive, noting the percentage of Grade 3 or higher treatment-related adverse events (TRAEs) seen remains well below the rate observed in studies of Opdivo and Bristol-Myer's Yervoy (ipilimumab).
Studies of Opdivo and Yervoy showed similar response rates according to Simeonidis, but the 18% of patients experiencing Grade 3 or higher TRAEs knocks the 50%+ seen in Opdivo/Yervoy studies out of the water.
Incyte stock rose nearly 5% in Wednesday trading on the news, closing at $93.20 per share before slipping a little under 1% Thursday from that mark.