Kite and Kiniksa Pharmaceuticals Announce Clinical Collaboration Evaluating Investigational Combination of Yescarta and Mavrilimumab in Relapsed or Refractory Large B-Cell Lymphoma
Phase 2 study will Examine the Effect of Mavrilimumab on the Clinical Profile of Yescarta --
SANTA MONICA, Calif., &?HAMILTON, Bermuda--(BUSINESS WIRE)--Dec. 11, 2019-- Kite, a?Gilead Company?(Nasdaq: GILD), and?Kiniksa Pharmaceuticals, Ltd.?(Nasdaq: KNSA) (?Kiniksa?) announced today that the companies have entered into a clinical collaboration to conduct a Phase 2, multicenter study of mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRa), in combination with Yescarta??(axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Kite will be the sponsor of this study and will be responsible for its conduct.This press release features multimedia. View the full release here:?https://www.businesswire.com/news/home/20191211005149/en/
?We were excited to present data from several abstracts at the recent ASH meeting that build upon our understanding of the efficacy and safety profile of Yescarta and we are committed to the exploration of new approaches and treatment combinations that further optimize outcomes for patients,? said?Christi Shaw, Chief Executive Officer of Kite. ?We look forward to working with Kiniksa to learn more about the potential impact of GM-CSFRa inhibition with mavrilimumab.? ?The clinical collaboration with Kite furthers Kiniksa?s goal to develop life-changing medicines for patients with significant unmet medical need,? said?Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. ?We believe the potential for GM-CSFRa inhibition to advance the clinical profile for CAR T cell therapy speaks to the potential broad utility of mavrilimumab.? Treatment related induction of GM-CSF has been identified through clinical, translational and preclinical studies as a potential key signal associated with side effects of chimeric antigen receptor T (CAR T) cell therapy. Preclinical evidence shows the potential for interruption of GM-CSF signaling to disrupt CAR T cell mediated inflammation without disrupting anti-tumor efficacy. Yescarta was the first CAR T cell therapy to be approved by the?U.S. Food and Drug Administration?(FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of cytokine release syndrome and neurologic toxicities; see below for Important Safety Information. Mavrilimumab, alone or in combination with other therapies such as Yescarta, is investigational and has not been approved by the?FDA?or any regulatory authority for any uses. Efficacy and safety have not been established. About Mavrilimumab Mavrilimumab is an investigational fully-human monoclonal antibody that is designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor. Kiniksa is developing mavrilimumab for the potential treatment of giant cell arteritis (GCA), a chronic inflammatory disease of medium to large arteries. U.S. Important Safety Information for Yescarta BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta?. Do not administer Yescarta??to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta?, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta?. Provide supportive care and/or corticosteroids as needed.
- Yescarta??is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta?REMS.
U.S. Prescribing Information for Yescarta, including?BOXED WARNING, is available at?www.kitepharma.com?and?www.gilead.com.
Yescarta is a registered trademark of?Gilead Sciences, Inc., or its related companies.
For more information on Kite, please visit the company?s website at?www.kitepharma.com. Learn more about Gilead at?www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com:?https://www.businesswire.com/news/home/20191211005149/en/
Source: Kite, a?Gilead Company & Kiniksa Kite Contacts: Greg Mann, Investors (424) 322-1795 Nathan Kaiser, Media (650) 522-1853 Kiniksa Contact: Mark Ragosa, Investors and Media (781) 430-8779