European Commission Approves KEYTRUDA + Chemo as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable NSCLC at High Risk of Recurrence in Adults
“Today’s approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer,” said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need.”
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“We are pleased to evaluate the clinical combination of IDE892 with RG6505 in MTAP-deleted RAS-mutant PDAC,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. “This collaboration aligns with our broader clinical strategy to evaluate rational combinations with assets in our MTAP-deletion portfolio, and there remains especially high
“In the first reported data from the clinical combinations of our PRMT5 inhibitor vopimetostat and RAS(ON) inhibitors, we saw extremely encouraging early results, with 92% of patients with PDAC in the vopimetostat plus daraxonrasib arm achieving an objective response, supporting the preclinical data showing synergistic activity of PRMT5 + RAS
“Non-small cell lung cancer is the most prevalent lung disease with more than 8,000 patients in the U.S. diagnosed each year with KRAS G12D-mutations. Receiving Fast Track designation for VS-7375 reinforces both the significant unmet need and the potential of VS-7375 to improve outcomes for patients with KRAS G12D-mutated lung
“KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years,” said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. “We believe the proprietary Firelink™ platform will overcome