Drug Development

In light of Incyte’s epacadostat debacle, NewLink scraps PhIII plans for its own IDO drug

After seeing its shares get dragged down by Incyte’s late-stage debacle, NewLink Genetics is scrapping a PhIII trial for its own IDO drug, raising further questions about the pathway.

It will not initiate the randomization portion of Indigo301, the Ames, IA-based company $NLNK said, a melanoma study that would have evaluated indoximod in combination with checkpoint inhibitors Keytruda or Opdivo in 600 patients. In a press release, NewLink explained the decision was made “in the context of the failure of a competitor’s trial of its enzymatic IDO inhibitor in a similar clinical setting.”

Incyte suffered a bitter setback for its IDO1 drug epacadostat almost two weeks ago, as investigators halted a Phase III study in metastatic melanoma after finding the combo of epacadostat and Merck’s PD-1 star Keytruda ineffective in progression-free survival and unlikely to extend overall survival. A leader in the IDO field, the company told analysts that the ECHO-301 study failure “has a negative impact on the probability of success of the other (combination) studies.”

Charles Link, NewLink

NewLink has apparently heeded its rival’s warning. The plan now is for the clinical team to look into an alternative way to test indoximod in melanoma — the design, trial size and feasibility. They will take into account the full data set from the company’s single-arm PhII melanoma trial, with final results scheduled to come out later this year.

Last year, researchers rolled out a set of data from the PhII study with indoximod and Keytruda, touting a median progression-free survival rate at 12.9 months. They also reported an increase in the complete response rate from 12% to 20%n an overall response rate of 61% and a disease control rate of 80%.

Despite the switch-up, the company wants people to remember that indoximod has a different mechanism of action from direct enzymatic inhibitors like epacadostat.

NewLink’s shares took another dip at the news, falling as much as 15% (though nothing serious compared to the 44% hit it took after the Incyte failure broke) before climbing back up.


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Aro Biotherapeutics Company Denver, CO
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Aro BioTx Philadelphia, PA
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Molecular Templates Austin, TX
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Molecular Templates Austin, TX

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