NewLink Genetics to review clinical programmes following failed Merck & Co., Incyte melanoma trial of IDO inhibitor

NewLink Genetics stated Friday that it will review its clinical programmes in light of the failure of the Phase III ECHO-301/KEYNOTE-252 trial evaluating Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) in combination with Incyte's IDO1 inhibitor epacadostat in patients with unresectable or metastatic melanoma. Merck and Incyte's study did not meet its primary endpoint of progression-free survival and the companies have decided to halt the trial. Shares in NewLink, whose lead therapies indoximod and NLG802 target the IDO pathway, fell as much as nearly 45 percent on the news.

NewLink noted that indoximod has a "differentiated mechanism of action which may demonstrate clinical benefit for patients where direct enzymatic inhibitors have not." The company added that it is due to present new data at the American Association for Cancer Research (AACR) annual meeting next week "further supporting indoximod's differentiated mechanism of action," as well as "encouraging" early clinical results of indoximod plus radiation for paediatric patients with diffuse intrinsic pontine glioma.

FirstWord reports in this therapy area - KOL Insight Malignant Melanoma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Indoximod is being evaluated in combination with Keytruda or Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) in the Phase III Indigo301 trial of patients with advanced melanoma. The drug is also being tested in a mid-stage study as an addition to AstraZeneca's anti-PD-L1 monoclonal antibody Imfinzi (durvalumab), along with standard chemotherapy, for patients with metastatic pancreatic cancer.

Meanwhile, Bristol-Myers Squibb last year released Phase I/IIa study data indicating that the combination of Opdivo plus its experimental IDO1 inhibitor BMS-986205 led to an "encouraging response" among heavily pre-treated patients with advanced bladder and cervical cancers.

For related analysis, see ViewPoints: ECHO-301 failure will reverberate throughout I/O universe.


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