![]() ![]() Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. 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 was the first CAR T cell therapy to be approved by the U.S. Preclinical evidence shows the potential for interruption of GM-CSF signaling to disrupt CAR T cell mediated inflammation without disrupting anti-tumor efficacy. 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. “We believe the potential for GM-CSFRα inhibition to advance the clinical profile for CAR T cell therapy speaks to the potential broad utility of mavrilimumab.” Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. ![]() “The clinical collaboration with Kite furthers Kiniksa’s goal to develop life-changing medicines for patients with significant unmet medical need,” said Sanj K. “We look forward to working with Kiniksa to learn more about the potential impact of GM-CSFRα inhibition with mavrilimumab.” “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. Kite will be the sponsor of this study and will be responsible for its conduct. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. (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-CSFRα), in combination with Yescarta ® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma. Kite, a Gilead Company (Nasdaq: GILD), and Kiniksa Pharmaceuticals, Ltd. SANTA MONICA, Calif., & HAMILTON, Bermuda-(BUSINESS WIRE)-Dec. Phase 2 study will Examine the Effect of Mavrilimumab on the Clinical Profile of Yescarta. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |