Incyte’s complete response rate for a mid-stage combo of its IDO1 drug epacadostat with checkpoint legend Keytruda took a hit in the latest data update, but the growing biotech came away with a thumbs-up from analysts who have been tracking this trial carefully.
Leerink’s Michael Schmidt took a close look, and was comforted overall to see some consistency and continued promise. His bottom line:
Efficacy and safety data highlighted in the abstract in this larger (n=54) melanoma cohort look very consistent relative to earlier dose-escalation results presented previously in n=19 patients. Importantly, data continue to compare favorably not only to historic Keytruda or Opdivo monotherapy results, but also compared to the combination of Opdivo with Yervoy in treatment-naïve metastatic melanoma patients, which we think bodes well for the probability-ofsuccess of the ongoing ECHO-301 Phase III trial, which is expected to read out in early 1H18.
That’s based on these results, which included a drop in complete responses from 26% to 13%:
1. In all 54 efficacy evaluable patients, reports Leerink, an ORR of 56% was achieved (8 complete responses [CRs] and 22 partial responses [PRs], n=54 patients). In treatment-naïve patients, an ORR of 56% was achieved (6 CRs and 19 PRs, n=45 patients). In treatment-naïve patients receiving the Phase III epacadostat dose (100mg BID) an ORR of 60% was achieved (2 CRs and 16 PRs, n=30 patients). This compares to the ORR of 58% in n=19 treatment-naïve patients presented previously at ESMO 2016.
2. In all 54 evaluable patients, a median progression-free survival [PFS] of 12.4 months was achieved with PFS rates at 6, 12, and 18 months of 70%, 54%, and 50%, respectively. In treatment naïve patients, median PFS had not been reached with PFS rates at 6, 12, and 18 months of 68%, 52%, and 52%, respectively.
So far, so good. We’ll keep updating these small numbers from ECHO-202 while the pivotal trial progresses to a near-term readout.
It’s been a good week for Incyte, which announced with Eli Lilly yesterday that the FDA is letting the partners resubmit their rheumatoid arthritis drug baricitinib without the new late-stage trial that was insisted on earlier this year. If in fact the FDA changed its mind, after the arrival of Scott Gottlieb as commissioner, then the agency has shifted course on safety. That’s a big deal for everyone.
In the meantime, Incyte is also pursuing its own PD-1 program with a partner, looking to line up an in-house combo that could eventually supplant agnostic collaborations with Merck and Bristol-Myers Squibb.
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