Stephen Hodi, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute and Steering Committee Chair for the study, said, “Talimogene laherparepvec is designed to promote tumor antigen release and presentation to initiate an anti-tumor immune response, which may be complementary to Keytruda's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses. The trial will also assess the safety of talimogene laherparepvec in combination with pembrolizumab.į. ![]() The two drugs will be studied in a multicenter, open label clinical trial for their efficacy as a combination treatment compared to Keytruda alone and following progression after monotherapy with Keytruda. The drug is also being studied as treatment for relapsed/refractory classical Hodgkin Lymphoma (cHL) as well as in other indications. Pembrolizumab received its second breakthrough therapy designation in the U.S. Keytruda is an FDA-approved monoclonal antibody (mAb) that inhibits PD-1 from interacting with its ligands PD-L1 and PD-L2. Food and Drug Administration (FDA) as well as a Marketing Authorization Application in the EU for the drug as treatment for patients with regionally or distantly metastatic melanoma. Amgen has filed a Biologics License Application with the U.S. ![]() Talimogene laherparepvec is an investigational oncolytic immunotherapy which selectively replicates in tumors, but not in normal tissue to trigger an immune response against metastasized cancer cells. Merck and its partner Amgen announced the initiation of the clinical trial investigating the combination immunotherapy of Amgen’s talimogene laherparepvec with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with regionally or distantly metastatic melanoma.
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