2:26 PM
Apr 16, 2018
 |  BC Extra  |  Clinical News

NewLink re-evaluating Phase III plans for indoximod combo

NewLink Genetics Corp. (NASDAQ:NLNK) said Sunday that 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 Extra, April 6).

On April 6, NewLink said it would review its clinical programs in light of the ECHO-301 data, and lost 43% to $4.20 on the Incyte news.

NewLink said Sunday that its clinical team will evaluate the design, trial size and feasibility of an "alternative randomized evaluation" of indoximod to treat melanoma. The evaluation will include analysis of the full data set from its single-arm Phase II trial of indoximod plus Yervoy ipilimumab, Keytruda or Opdivo for metastatic melanoma, the "differentiated" mechanism of action of indoximod, and expert opinions.

Final data from the Phase II trial are slated to be presented at a medical meeting this half (see BioCentury Extra, Sept. 7, 2017).

NewLink also reported data on Sunday from the Phase I NLG2105 trial of indoximod to treat pediatric patients with progressive primary malignant brain tumors. In 29 evaluable patients, indoximod plus radiation or chemotherapy led to a median PFS of 6.2 months. The trial is also enrolling a cohort of newly diagnosed patients with diffuse intrinsic pontine glioma (DIPG). Data were presented at the American Association for Cancer Research meeting in Chicago.

NewLink was off $0.35 to $4.13 on Monday.

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