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 Patients
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Oncologic Drugs Advisory Committee (ODAC) determines risks outweigh benefits in some cancers for frontline immune checkpoint inhibitors, including blockbuster drugs such as Keytruda and Opdivo, in patients with low PD-L1 expression - Multikine has shown survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression
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Multikine has potential as a combination drug with current checkpoint inhibitors such as Keytruda which is projected to be the top selling drug in the world with
$27 billion in 2024 sales - To the Company’s 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
FDA advisory committees provide independent expert advice to the FDA on the safety and effectiveness of new and marketed drugs and help the agency make sound and informed decisions. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The
- adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population
- differing risk-benefit assessments in different subpopulations defined by PD-L1 expression
- adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression
Following a thorough analysis of peer-reviewed published data, the panel of experts on the ODAC voted 10-2 and 11–1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Most ODAC members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the immune checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients.
Checkpoint inhibitors were an estimated
“The FDA advisory committee’s findings and public statement on the risk-benefit of checkpoint inhibitors based on PD-L1 expression is potentially a turning point in cancer treatment, pointing to a major treatment gap in low and negative PD-L1 patients. While the approved blockbuster checkpoint inhibitors, including Keytruda which is expected to be the biggest selling drug in 2024, work well in high PD-L1 expressing patients, to our knowledge, Multikine is the only immunotherapy that is targeted to and has shown survival benefit in the low and negative PD-L1 population.
“The FDA’s ODAC decision further supports our belief that Multikine holds strong potential in treating patients across a wider range of solid tumor cancer indications alone and in combination regimens,” Kersten concluded.
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 agreed to 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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