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Posted On: 08/06/2025 11:41:12 AM
Post# of 107985
$CVM Recent News : FDA’s Approval of Keytruda for PD-L1 Positive Head and Neck Cancer Patients Signals a Clear Pathway for CEL-SCI’s Multikine to Address a Major Unmet Need in PD-L1 Negative Cancer Patients
FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval
Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival
Pre-operative treatments from CEL-SCI and Merck have the potential to offer clinical benefit for locally advanced resectable head and neck cancer patients across the PD-L1 expression spectrum
VIENNA, Va., June 18, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today applauded the U.S. Food and Drug Administration’s (FDA) approval of Merck’s KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test. Merck’s application was granted the FDA’s priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.
Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.
https://finance.yahoo.com/news/fda-approval-k...00220.html
FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval
Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival
Pre-operative treatments from CEL-SCI and Merck have the potential to offer clinical benefit for locally advanced resectable head and neck cancer patients across the PD-L1 expression spectrum
VIENNA, Va., June 18, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today applauded the U.S. Food and Drug Administration’s (FDA) approval of Merck’s KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test. Merck’s application was granted the FDA’s priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.
Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.
https://finance.yahoo.com/news/fda-approval-k...00220.html
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