Citations 1
Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence
Slingluff, Craig L. , Lewis, Karl D. , Andtbacka, Robert Hans Ingemar, Hyngstrom, John , Milhem, Mohammed , Bowles, Tawnya L. , Hamid, Omid , Hernandez‐Aya, Leonel F. , Claveau, Joël, Jang, Sekwon, Philips, Prejesh, Holtan, Shernan G. , Shaheen, Montaser , Curti, Brendan D. , Schmidt, William, Butler, Marcus O. , Paramo, Juan, Lutzky, Jose , Padmanabhan, Arvinda, Thomas, Sajeve , Milton, Daniel T., Pecora, Andrew L. , Sato, Takami , Hsueh, Eddy C. , Badarinath, Suprith, Keech, John A., Kalmadi, Sujith, Kumar, Pallavi , Weber, Robert, Levine, Edward A. , Berger, Adam C. , Bar, Anna, Travers, Jeffrey B. , Mihalcioiu, Catalin , Gastman, Brian , Beitsch, Peter D. , Rapisuwon, Suthee , McCarron, Edward C. , Gupta, Vinay , Behl, Deepti , Blumenstein, Brent A. , Peterkin, Joanna, Curti, Brendan , Lutzky, Jose , Rapisuwon, Suthee , Milhem, Mohammed M , Butler, Marcus O , Levine, Edward A , Holtan, Shernan , Markovic, Svetomir N. , Paramo, Juan, Milton, Daniel, Beck, J. Thaddeus , Glaspy, John A.
Journal for ImmunoTherapy of Cancer | October 1, 2021 | Volume: 9 | Issue: 10 | Pages: e003272
Background Most patients with advanced melanomas relapse after checkpoint blockade therapy. Thus, immunotherapies are needed that can be applied safely early, in the adjuvant setting. Seviprotimut-L is a vaccine containing human melanoma antigens, plus alum. To assess the efficacy of seviprotimut-L, the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was initiated as a three-part multicenter, double-blind, placebo-controlled phase III trial. Results from part B1 are reported here. Methods Patients with AJCC V.7 stage IIB-III cutaneous melanoma after resection were randomized 2:1, with stage stratification (IIB/C, IIIA, IIIB/C), to seviprotimut-L 40 mcg or placebo. Recurrence-free survival (RFS) was the primary endpoint. For an hypothesized HR of 0.625, one-sided alpha of 0.10, and power 80%, target enrollment was 325 patients. Results For randomized patients (n=347), arms were well-balanced, and treatment-emergent adverse events were similar for seviprotimut-L and placebo. For the primary intent-to-treat endpoint of RFS, the estimated HR was 0.881 (95% CI: 0.629 to 1.233), with stratified logrank p=0.46. However, estimated HRs were not uniform over the stage randomized strata, with HRs (95% CIs) for stages IIB/IIC, IIIA, IIIB/IIIC of 0.67 (95% CI: 0.37 to 1.19), 0.72 (95% CI: 0.35 to 1.50), and 1.19 (95% CI: 0.72 to 1.97), respectively. In the stage IIB/IIC stratum, the effect on RFS was greatest for patients <60 years old (HR=0.324 (95% CI: 0.121 to 0.864)) and those with ulcerated primary melanomas (HR=0.493 (95% CI: 0.255 to 0.952)). Conclusions Seviprotimut-L is very well tolerated. Exploratory efficacy model estimation supports further study in stage IIB/IIC patients, especially younger patients and those with ulcerated melanomas. Trial registration number NCT01546571.