Incyte Provides Update on Parsaclisib and MCLA-145

Rhea-AI Summary

Incyte announced the withdrawal of its New Drug Application (NDA) for parsaclisib in the U.S. for treating relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. This decision follows discussions with the FDA on confirmatory studies that could not be completed in a timely manner. Additionally, Incyte has opted out of the continued development of MCLA-145, but will maintain collaboration with Merus. Parsaclisib remains in ongoing Phase 2 and Phase 3 trials for other indications.

Positive

• Parsaclisib is still in Phase 2 trials for various non-Hodgkin lymphomas and a Phase 3 study for autoimmune hemolytic anemia.
• Ongoing collaboration with Merus will leverage their platform for developing new agents.

Negative

• Withdrawal of NDA for parsaclisib for multiple lymphoma indications may hinder revenue potential.
• Decision to opt out of MCLA-145 development may limit future growth opportunities.

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), and MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement with Merus.

Incyte is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The decision to withdraw the NDA follows discussions with U.S. Food and Drug Administration (FDA) regarding confirmatory studies to support an accelerated approval, which Incyte determined cannot be completed within a time period that would support the investment. The withdrawal of the NDA is a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. The decision impacts only the FL, MZL and MCL indications in the U.S., and does not affect other ongoing clinical trials in the U.S. or other countries.

Additionally, as part of its ongoing portfolio prioritization and capital allocation review, Incyte has decided to opt-out of the continued development of MCLA-145. Incyte will continue to collaborate with Merus and leverage their platform to develop a pipeline of novel agents.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and in a Phase 3 study for autoimmune hemolytic anemia (AIHA). Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are also underway.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of parsaclisib to provide a meaningful treatment for patients with non-Hodgkin lymphomas (NHLs), the parsaclisib development program generally and Incyte’s ongoing collaboration with Merus and ability to leverage the Merus platform to develop a pipeline of novel agents contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA or other regulatory authorities; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220125006021/en/

Media

Catalina Loveman +1 302 498 6171

cloveman@incyte.com

Jenifer Antonacci +1 302 498 7036

jantonacci@incyte.com

Investors

Christine Chiou +1 302 274 4773

cchiou@incyte.com

Source: Incyte

FAQ

Why did Incyte withdraw the NDA for parsaclisib?

Incyte withdrew the NDA due to the inability to complete necessary confirmatory studies in a timely manner.

What indications were affected by the NDA withdrawal?

The NDA withdrawal affects follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

Is Incyte still developing parsaclisib?

Yes, parsaclisib is still under evaluation in ongoing Phase 2 and Phase 3 trials for other indications.

What is the future for MCLA-145 after Incyte's decision?

Incyte has opted out of MCLA-145 development but will continue collaborating with Merus.