Clinical Trials
Phase III Study
Phase III Study
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase III 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. MAVIS is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Background
By intent-to-treat (ITT) analysis, RFS was not significantly enhanced for seviprotimut-L in the overall study population but did trend slightly higher. However, strong responses were seen in two well-defined subpopulations based on disease stage and age at time of treatment. Specifically, interim efficacy analysis of subgroups based on pre-planned stratification suggested enhanced RFS for seviprotimut-L among two patient populations: those with AJCC Stage IIB/C melanoma and those under the age of 60.
Age has been identified as a cause of decreased immune competence1; thus, outcomes were assessed as a function of age as an effect modifier. Effects estimates for patients aged less than 60 years are favorable to seviprotimut-L in the overall population (Hazard Ratio= 0.61, 95% CI [0.36, 1.05]) and in the Stage IIB/IIC population (Hazard Ratio= 0.239, 95% CI [0.083, 0.69]).
Seviprotimut-L is well-tolerated with treatment-emergent adverse events (AEs) similar to placebo patients. There were no serious adverse events or Grade 4 or 5 adverse events in the 347 patients studied, and the vast majority of events were Grade 1-2 injection site reactions that were managed by topical cream/s or an over-the-counter antihistamine
Conclusions
- Dorshkind K, Swain S. Age-associated declines in immune system development and function: causes, consequences, and reversal. Curr Opin Immunol 2009; 21: 404-407
A. RFS for the Overall Patient Population
B. RFS for Stage IIB/C Patient Subgroup
C. RFS by Age for the Overall Patient Population
D. RFS by Age for Stage IIB/C Patients
| ____Table 1: Enrollment and adverse events | Seviprotimut-L | Placebo |
|---|---|---|
| N | 230 | 117 |
| AEs | 96% | 97% |
| Grade 3 AEs | 12% | 9% |
| Grade 4-5 AEs | 0% | 0% |
| Rx-related AEs | 70% | 73% |
| Rx-related SAEs | 0% | 0% |
| AEs leading to d/c study drug | 0.9% | 0.9% |
| Rx-related AEs leading to d/c study drug | 0.4% | 0% |
Expanded Access
Polynoma does not presently offer an expanded access program (sometimes called “compassionate use” or “pre-approval access”) for seviprotimut-L. We are working diligently to accelerate the generation of data from clinical trials required by the US Food and Drug Administration (FDA) to enable the availability of seviprotimut-L in the United States as early as possible – this will make the therapy available to the broadest number of patients in need.
For information on participating in and status of seviprotimut-L clinical trials, please see https://clinicaltrials.