Craig Slingluff, MD of @UVACancerCenter answers the study design and what is next for phase III data for a melanoma vaccine, seviprotimut-L.
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— MAVIS Study Identifies Most Responsive Patient Subpopulations, Supporting the Continued Study of Adjuvant Treatment in Localized Melanoma Patients —
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., is presenting clinical data from MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), its ongoing Phase III clinical study of seviprotimut-L, an investigational melanoma vaccine candidate, on November 8 at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland.
MAVIS is an adaptive phase III multicenter, double-blind, placebo-controlled 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 American Joint Cancer Committee (AJCC) Stage IIB / C, IIIA, IIIB / C melanoma at high risk of recurrence following definitive surgical resection.
Highlights of the data presented include:
- Improved outcomes in Stage IIB/C patients: Interim analysis of subgroups suggested enhanced RFS for seviprotimut-L among those with AJCC stage IIB/IIC melanoma, as well as those under age 60.
- Favorable adverse event profile: Seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to patients given placebo.
Treatment of Stage IIB/IIC melanoma is primarily limited to surgery, coupled with a “wait and see” approach. However, recurrence of the disease can occur following definitive resection of the melanoma. Many patients progress to more advanced stages following resection and 5-year survival rates fall sharply after a patient passes from localized Stage II melanoma into regional Stage III disease (98.4% to 63.6%). Five-year survival rates are distinctly lower (22.4%) for metastatic Stage IV.1