August 31, 2017
By Mark Terry, Breaking News Staff


Incyte Corporation will have an abstract published at the European Society for Medical Oncology (ESMO) meeting in early September with new and updated data from its ongoing Phase I/II trial of epacadostat in combination with Merck & Co.’s Keytruda in advanced melanoma.

Across all the melanoma patients that could be evaluated for efficacy, the median progression-free survival (PFS) was 12.4 months. The rates for six months was 70 percent, 54 percent at 12 months and 50 percent at 18 months. In patients who had not received treatment for advanced disease and where the median PFS hadn’t been reached, there were PFS rates of 68 percent at six months, and 52 percent for both 12 and 18 months.

“We are encouraged by these additional data from our ECHO-202 trial, which demonstrate robust and durable responses in patients with advanced melanoma treated with the combination of epacadostat and Keytruda,” said Steven Stein,Incyte’s chief medical officer, in a statement. “These results further underscore the potential of this novel immunotherapy combination, and we look forward to reporting more detailed results from this study at ESMO next month.”

Michael Schmidt, an analyst with Leerink, wrote in a note to investors, “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 continued 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 of success of the ongoing ECHO-301 Phase III trial, which is expected to read out in early 1H18.”

Yesterday, Incyte and Eli Lilly and Company (LLY) announced that Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018 to the U.S. Food and Drug Administration (FDA). It will include new safety and efficacy data, and is expected to be classified as a Class II resubmission, which will trigger a new six-month review cycle. Baricitinib is a once-daily oral drug for moderate-to-severe rheumatoid arthritis (RA).

The FDA didn’t approve the drug before, requesting more clinical data on dosage and to clarify safety issues.

John Carroll, writing for Endpoints News, says, “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.”

Alethia Young, an analyst with Credit Suisse, wrote in a research note, “Incyte/Lilly announced today that after discussion with FDA, they plan to resubmit with new efficacy and safety data before the end of January 2018. We spoke to the company post press release today and think this update is faster than what the company said in July press release that resubmission can take a minimum of 18 months. The class 2 review would take six months so baricitinib can be on the market as early as 2H 2018 (with a likely approval in mid-2018). We are not sure what made FDA change its mind but think the new timeline is positive to the company. The resubmission would include new data, new analysis of the old data, post-marketing experience in EU and Japan, and longer follow-up data from patients on RA trial.”

Both sets of good news worked to give Incyte stock a boost. Shares traded at $121.76 on Friday, Aug. 26, and jumped to $138.28 on Aug. 30. Shares are currently trading for $133.77.



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