U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025
Cel-Sci Corporation (CVM)
NASDAQ:AMEX Investor Relations:
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Company Research
Source: Business Wire
Biomarker used to select patients who are more likely have favorable outcomes, supporting a successful confirmatory Registration StudyPatients with low PD-L1 expression treated with Multikine in the target population had a 5-year survival of 73% vs. 45% in the control group in the prior randomized controlled Phase 3 study VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. This study will focus on the treatment of newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low (TPS PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, a class of cancer drugs representing a $48 billion global market in 2023, led by pembro
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News
- CEL-SCI Co. (NYSE: CVM) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- CEL-SCI files to sell 1M shares of common stock for holders [Seeking Alpha]Seeking Alpha
- FDA’s Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI’s Multikine® to Address Major Treatment Gap for PD-L1 Negative Cancer PatientsBusiness Wire
- CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck CancerBusiness Wire
- CEL-SCI's Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation [Yahoo! Finance]Yahoo! Finance
CVM
Earnings
- 8/14/24 - Miss
CVM
Sec Filings
- 11/15/24 - Form 8-K
- 11/13/24 - Form 8-K
- 11/8/24 - Form EFFECT
- CVM's page on the SEC website