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Incyte, Merck Provide Collaboration Now Includes Seven Registrational Trials across Five Tumor Types.

M2 PHARMA-March 31, 2017-Incyte, Merck Provide Collaboration Now Includes Seven Registrational Trials across Five Tumor Types

(C)2017 M2 COMMUNICATIONS

- US-based pharmaceutical companies Incyte Corp. (NASDAQ: INCY) and Merck (NYSE: MRK) have expanded their clinical development program investigating the combination of epacadostat, Incyte's investigational oral selective IDO1 enzyme inhibitor, with Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, the companies said.

This collaboration now involves patients across five tumor types, including metastatic melanoma, non-small cell lung cancer (NSCLC), bladder cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck (SCCHN).

The expanded collaboration now includes seven pivotal studies.

These include Phase 3 study in metastatic melanoma (trial underway); two Phase 3 studies in first-line NSCLC, including both PD-L1 high-expressing and PD-L1 unselected populations; two Phase 3 studies in bladder cancer, including one in first-line bladder cancer and one in second-line bladder cancer; a Phase 3 study in first-line RCC; and a Phase 3 study in first-line SCCHN.

Incyte and Merck will share responsibilities for funding these pivotal studies, and Merck will be responsible for conducting the trials.

The ECHO clinical trial programme was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology.

Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies.

ECHO-301 (NCT02752074), a Phase 3 randomised, double-blind, placebo-controlled study investigating

Keytruda in combination with epacadostat or placebo for the first-line treatment of patients with advanced or metastatic melanoma, is also underway.

Indoleamine 2,3-dioxygenase 1 is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance.

Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that reverses tumor-associated immune suppression and restores effective anti-tumor immune responses.

In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor Keytruda improved response rates compared with studies of the immune checkpoint inhibitors alone.

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Publication:M2 Pharma
Date:Mar 31, 2017
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