NewLink re-evaluating Phase III plans for indoximod combo in melanoma
NewLink Genetics Corp. (NASDAQ:NLNK) said it will not start the randomized, placebo-controlled portion of the Phase III Indigo301 trial to evaluate indoximod (NLG8189) plus anti-PD-1 mAbs Keytruda pembrolizumab or Opdivo nivolumab to treat unresectable or metastatic melanoma. The company had planned to start the randomized portion of the trial in 2Q18 or 3Q18. Indoximod is an indoleamine 2,3-dioxygenase (INDO; IDO) pathway inhibitor.
The news comes on the heels of data reported by Incyte Corp. (NASDAQ:INCY) and partner Merck & Co. Inc. (NYSE:MRK) showing that Incyte's epacadostat plus Merck’s Keytruda missed the primary endpoint of improving progression-free survival (PFS) vs. Keytruda alone in the Phase III ECHO-301/KEYNOTE-252 trial as first-line treatment of unresectable or metastatic melanoma. Epacadostat is an indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor (see BioCentury, April 13)...