Phase III Data for Investigational Melanoma Vaccine, Seviprotimut-L #SITC @UVACancerCenter

Phase III Data for Investigational Melanoma Vaccine, Seviprotimut-L #SITC @UVACancerCenter

UVA Cancer Center

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Craig Slingluff, MD of @UVACancerCenter discusses the 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 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

Read here: https://www.oncologytube.com/video/annual-meeting-of-the-society-for-immunotherapy-of-cancer-sitc-2019-polynoma-presenting-interim-phase-iii-evidence-for-its-investigational-melanoma-vaccine-seviprotimut-l

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