NewLink Genetics' shares slip on potential change to Phase III study of indoximod in melanoma

NewLink Genetics disclosed that it will not initiate the randomised portion of the Phase III Indigo301 study of indoximod in combination with Merck & Co.'s Keytruda (pembrolizumab) or Bristol-Myers Squibb's Opdivo (nivolumab) following a review of the programme. Shares in the company fell as much as 15 percent on the news.

The drugmaker recently began an assessment of its clinical programmes following the failure of the Phase III ECHO-301/KEYNOTE-252 trial evaluating Keytruda in combination with Incyte's IDO1 inhibitor epacadostat in patients with unresectable or metastatic melanoma. NewLink is developing indoximod and NLG802, which both target the IDO pathway.

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NewLink indicated that it will review the design, trial size and feasibility of an alternative randomised evaluation of indoximod in melanoma in the context of the failure of the ECHO-301/KEYNOTE-252 trial. The company noted that it will assess the full data set from a single-arm Phase II melanoma study and the opinions of experts in the field, whilst also taking into account "the differentiated mechanism of action of indoximod."

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

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