12/29/2023 0 Comments Antibody sequence analysisJemperli is not approved anywhere in the world in combination with chemotherapy in first-line patients with metastatic non-squamous NSCLC or in combination with other agents to treat patients with advanced NSCLC who have progressed on prior anti-PD-L1 therapy and chemotherapy. Jemperli is being investigated in registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers. Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. The primary endpoint is overall survival. The study does not include patients with a known sensitizing epidermal growth factor receptor, anaplastic lymphoma kinase, or receptor tyrosine kinase-1 mutation, for which an approved targeted therapy is available. The study evaluates the efficacy and safety of cobolimab plus dostarlimab plus docetaxel and dostarlimab plus docetaxel compared to docetaxel in patients with advanced non-squamous and squamous NSCLC whose disease had progressed on prior therapy with an anti-PD-(L)1 agent and a platinum doublet-based chemotherapy given in combination or in sequence. The COSTAR Lung trial is a phase II/III global, randomized, open-label trial of 750 patients. Secondary endpoints include investigator-assessed progression-free survival per RECIST v1.1, overall survival, and safety. The primary endpoint was objective response rate of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy assessed by blinded independent central review per RECIST v1.1. The PERLA phase II trial is a global, randomised, double-blind trial of 243 patients evaluating the efficacy and safety of dostarlimab plus chemotherapy compared to pembrolizumab plus chemotherapy in patients with metastatic non-squamous NSCLC without a known sensitising epidermal growth factor receptor, anaplastic lymphoma kinase, or receptor tyrosine kinase-1 mutation, V600E mutation of the BRAF gene or other genomic mutation for which an approved targeted therapy is available. Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “These trials support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.” The COSTAR Lung phase III trial is a randomized, open label 3-arm trial comparing cobolimab, an investigational selective anti–TIM-3 monoclonal antibody, plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-L1 therapy and chemotherapy. The decision follows the recommendation of the Independent Data Monitoring Committee, given that the trial met its pre-specified expansion criteria per protocol. In addition, GSK is also advancing both arms of the COSTAR Lung trial into phase III. The most common treatment-emergent adverse reactions were anaemia, asthenia, nausea, constipation, cough, dyspnoea, vomiting, decreased appetite, and neutropenia. The safety and tolerability profile of dostarlimab in the PERLA phase II trial was consistent with previous clinical trials of similar regimens. The PERLA phase II trial is a randomised, double-blind trial of 243 patients and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this population.The trial was not designed to demonstrate superiority.įull results from the PERLA phase II trial, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, with results by programmed death ligand-1 (PD-L1) expression subgroups, will be presented at an upcoming scientific meeting. The trial evaluated dostarlimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in first-line patients with metastatic non-squamous non-small cell lung cancer (NSCLC). LONDON, UK I OctoI GSK plc (LSE/NYSE: GSK) today announced positive headline results of the PERLA phase II trial, which met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) criteria as determined by blinded independent central review. COSTAR, the phase II/III trial combining dostarlimab with cobolimab, a TIM-3 antagonist, in advanced NSCLC advances to phase III.PERLA is the largest global head-to-head trial of PD-1 inhibitors in this population.
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