Incyte Corporation (Nasdaq: INCY) announced today that it has entered into a clinical trial collaboration agreement with Merck, through a Merck subsidiary, to evaluate the safety and efficacy of Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, and Merck’s investigational anti-PD-1 immunotherapy, MK-3475, in a Phase I/II study in previously treated metastatic and recurrent non-small cell lung cancer (NSCLC), and other advanced or metastatic cancers.
Both INCB24360 and MK-3475 are part of a new class of cancer treatments known as immunotherapies that are designed to enhance the body’s own defenses in fighting cancer. INCB24360 and MK-3475 target distinct regulatory components of the immune system, and there is preclinical evidence suggesting that the combination of these two agents may lead to an enhanced anti-tumor immune response than either agent alone.
“The field of immunotherapy is evolving rapidly. Given the synergistic activity we have seen with our IDO1 inhibitor when combined with checkpoint inhibitors in preclinical models, we look forward to working with Merck on this initial clinical collaboration,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “To further our understanding of the therapeutic value of our IDO1 inhibitor, we intend to establish additional clinical collaborations with other companies, cancer networks and academia.”
“We are pleased to be collaborating with Incyte to study MK-3475 as part of this novel combination regimen,” said Dr. Eric Rubin, Vice President, Clinical Development for Oncology, Merck Research Laboratories. “Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer."
Under the terms of the agreement, Incyte and Merck will collaborate on a Phase I/II study to evaluate the safety and efficacy of the combination in previously treated metastatic and recurrent NSCLC, and other advanced or metastatic cancers. The Phase I portion of the trial is expected to establish a recommended dose regimen of INCB24360 and MK-3475. In the Phase II portion of the study, all patients receive MK-3475 and patients will be randomized to receive either INCB24360 or matching placebo. The study, which is expected to begin in the first half of 2014, will be co-funded by Incyte and Merck and conducted by Incyte. Results from this first study with Merck will be used to determine whether further clinical development of this combination is warranted.