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
- Biomarker used to select patients who are more likely have favorable outcomes, supporting a successful confirmatory Registration Study
- Patients 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
PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, a class of cancer drugs representing a
“To our knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population. This underscores the critical importance of having reached an agreement with the FDA on the method for identifying and selecting patients with low PD-L1 tumor expression for our upcoming confirmatory Registration study,” stated
“Patient selection based on low PD-L1 as a biomarker can boost the success of our upcoming confirmatory trial, further enhancing our confidence based on the retrospective data from our Phase 3 study. We appreciate the ongoing dialog, exchange of ideas and information with the FDA in support of CEL-SCI’s groundbreaking work as we aim to treat an unmet need in cancer patients with low PD-L1 expression.”
About
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the very strong data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients.
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* Multikine (Leukocyte Interleukin, Injection) is the trademark that
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