New study aims to cement Multikine’s role in pre-surgical immunotherapy, offering hope for enhanced survival rates.
In a significant advancement for cancer treatment, CEL-SCI Corporation (NYSE American: CVM) announced today that it has received the U.S. Food and Drug Administration’s (FDA) approval to proceed with a confirmatory clinical study of its innovative cancer immunotherapy, Multikine. This approval follows robust results from the largest ever Phase 3 study involving 928 patients with locally advanced primary head and neck cancer, signaling a potential paradigm shift in treating this challenging disease.
The FDA’s green light allows CEL-SCI to initiate a 212-patient confirmatory study, designed to further validate the efficacy and safety of Multikine administered before surgery. “This marks a tremendous step forward not just for CEL-SCI, but for the many patients who may benefit from our treatment in the years to come,” said Geert Kersten, CEO of CEL-SCI. “With the confirmatory study, we aim to reinforce the compelling survival benefits we observed in the Phase 3 trial.”
Multikine, the first immunotherapeutic agent of its kind, is intended to enhance the patient’s immune response against cancer at the earliest stage of the disease. In previous studies, patients treated with Multikine showed a remarkable 73% survival rate compared to 45% for those who received the current standard of care alone.
The upcoming study will focus on newly diagnosed patients who exhibit no lymph node involvement and low PD-L1 tumor expression, factors that were associated with the highest increase in survival rates in earlier trials. “Our goal with the confirmatory study is not only to confirm what we’ve learned but also to bring a new standard of care to patients at an earlier and potentially more curable stage of cancer,” added Kersten.
Head and Neck Cancer Global Market Size
The global market for head and neck cancer therapeutics is experiencing significant growth and is projected to continue expanding over the next decade. In 2023, the market size reached approximately $1.67 billion and is expected to grow at a compound annual growth rate (CAGR) of 11.2% through 2032, potentially reaching around $4.32 billion by the end of the forecast period. The increase is primarily driven by the rising prevalence of head and neck cancers and the development of new therapies, including targeted and immunotherapies.
In terms of therapy types, targeted therapy and immunotherapy are prominent segments contributing to the market growth. Targeted therapies, particularly those using EGFR monoclonal antibodies, have shown promising results, though they also carry risks of long-term side effects which could restrain their market growth slightly.
Geographically, North America holds the largest share of the market, attributed to advanced healthcare infrastructure, high awareness of the disease, and substantial government support for healthcare development. However, the Asia Pacific region is expected to witness the fastest growth due to increasing geriatric populations and a rising number of prescriptions for immunotherapy drugs.This dynamic market landscape is supported by ongoing advancements in treatment methodologies and the introduction of innovative drugs, which promise to enhance the efficacy of head and neck cancer therapies and improve patient outcomes.
CEL-SCI Path Forward
CEL-SCI’s pioneering work in cancer immunotherapy comes at a time when treatment options for head and neck cancer remain limited. The successful validation of Multikine could significantly alter clinical practice, introducing a new frontline therapy option that leverages the body’s own immune defenses before traditional interventions such as surgery and chemotherapy.
As CEL-SCI prepares for the rapid enrollment and execution of the confirmatory study, the global healthcare community watches closely, hopeful for a new tool in the fight against cancer. With FDA support and promising data backing its approach, CEL-SCI is poised to make a significant impact on how early-stage head and neck cancer is treated worldwide.
For more information on CEL-SCI’s innovative therapies and upcoming studies, visit CEL-SCI’s website.
