On January 11, 2022 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on a pivotal Phase 3 clinical study of seviprotimut-L, Polynoma’s melanoma cancer vaccine, for the adjuvant treatment of patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival (Press release, Polynoma, JAN 11, 2022, https://www.prnewswire.com/news-releases/polynoma-receives-special-protocol-assessment-spa-agreement-from-the-us-fda-for-a-pivotal-phase-3-clinical-study-of-seviprotimut-l-a-melanoma-cancer-vaccine-301457618.html [SID1234598604]). Seviprotimut-L previously received Fast Track designation from the U.S. FDA.
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Final analysis of Part B1 data from Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was recently published in the Journal for ImmunoTherapy of Cancer (JITC). A subgroup analysis of patients receiving seviprotimut-L with AJCC Stage IIB/IIC melanoma, under age 60 with a median follow-up time of 45.8 months (3.8 years), showed clinically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 68% (HR=0.32; 95% CI, 0.121, 0.864) compared to patients receiving placebo. Additionally, RFS was more favorable in patients under age 60 with ulcerated melanomas (HR 0.21; 95% CI: 0.065-0.702), and there was a trend toward improved overall survival (OS) (HR 0.34; 95% CI: 0.117, 0.975) for patients that received seviprotimut-L compared to those receiving placebo. Seviprotimut-L was extremely well tolerated, with adverse events (AEs) similar to patients that received placebo; there were no immune-mediated AEs or other treatment-related serious AEs observed.
"Vaccination with seviprotimut- L has an advantage of having very low toxicity, without significant immune-related adverse events and no significant increase in toxicity over placebo," said Craig L. Slingluff, Jr., MD, Professor of Surgery and Director of the Human Immune Therapy Center and lead author of the JITC research paper on MAVIS. "If definitive evaluation of this vaccine therapy confirms clinical benefit in patients with Stage IIB/IIC melanoma, particularly those aged 60 and younger, the low toxicity of this approach will be a valuable option for these patients."
"This SPA agreement with the U.S. FDA for our planned pivotal trial provides important guidance for the regulatory path towards approval of seviprotimut-L as an adjuvant treatment in Stage IIB/IIC melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Executive Officer at CK Life Sciences. "We believe results from this trial will support seviprotimut-L as the first choice in treating younger patients with localized melanoma."
About FDA Special Protocol Assessment
The SPA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for a new drug application. A SPA does not ensure the receipt of marketing approval or that the approval process will be faster than conventional regulatory procedures. Final marketing approval depends on efficacy and safety results and an evaluation of the overall benefits and risks of treatment after review of the data from the development program in its totality. For more information on Special Protocol Assessments, please visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry.
About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase 3 trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. For additional information about the trial, please visit View Source
About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB and IIC melanoma, following definitive resection.