seviprotimut-L (POL-103A) / CK Life Sci - LARVOL DELTA

Polynoma Receives Special Protocol Assessment (SPA) Agreement from the U.S. FDA for a Pivotal Phase 3 Clinical Study of Seviprotimut-L, a Melanoma Cancer Vaccine (PRNewswire) - P3, N=504; MAVIS (NCT01546571); Sponsor: Polynoma LLC; "Polynoma LLC...announced 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....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."

P3 data • Special protocol assessment • Melanoma • Oncology • Skin Cancer

Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (clinicaltrials.gov) - P3; N=504; Terminated; Sponsor: Polynoma LLC; N=1224 ➔ 504

Enrollment change • Melanoma • Oncology • Solid Tumor

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. (PubMed, J Immunother Cancer) - P3 | "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."

Clinical • Journal • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (clinicaltrials.gov) - P3; N=1224; Terminated; Sponsor: Polynoma LLC; Trial completion date: Dec 2025 ➔ Jun 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2021 ➔ Apr 2021; Planned interim analysis showed a strong signal of efficacy in a pre-specified patient population. Fast track designation was granted and a new, redesigned pivotal trial will be conducted.

Trial completion date • Trial primary completion date • Trial termination • Melanoma • Oncology • Solid Tumor

Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (clinicaltrials.gov) - P3; N=1224; Active, not recruiting; Sponsor: Polynoma LLC; Trial primary completion date: Jan 2025 ➔ Dec 2021

Trial primary completion date • Melanoma • Oncology • Solid Tumor

ASCO 2020: Abstract Recommendations From Dr. Ari VanderWalde for Melanoma (PracticeUpdate) - "Patients with resected high-risk stage III melanoma were randomized to receive pembrolizumab or placebo for 1 year or until disease progression or toxicity. After 3 years of follow-up, pembrolizumab was associated with a significantly prolonged recurrence-free survival (RFS) compared with placebo in the overall population and in patients with PD-L1–positive tumors....The authors report the 5-year outcomes following the use of adjuvant dabrafenib (D) plus trametinib (T) or placebo in patients with high-risk resected stage III BRAF V600E/K-mutant melanoma....Patients with stage III melanoma received two cycles of neoadjuvant ipilimumab 1 mg/kg and nivolumab 3 mg/kg (I1N3) following placement of a marker in the index lymph node (ILN). Resection of the ILN was completed at 6 weeks to allow the omission of therapeutic lymph node dissection (TLND) in patients achieving major pathologic response (MPR)."

Online posting

Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L (PRNewswire) - "Polynoma LLC…announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival."

Fast track designation • Melanoma • Oncology

Polynoma presenting final analysis of MAVIS phase III part b1 data of its investigational melanoma vaccine, seviprotimut-l, at ASCO20 virtual scientific program (PRNewswire) - "The study abstract is one of 12 abstracts selected for discussion in the Melanoma/Skin Cancers poster discussion session....Further details on poster presentation and discussion session: Abstract 10017: Final analysis of relapse-free survival in a multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine after resection of high-risk melanoma....Author...Omid Hamid, MD...Jose Lutzky, MD...Poster Discussion Session...Discussant: Kenneth F. Grossmann, MD, PhD..."

Polynoma presenting final analysis of MAVIS phase III Part B1 data of its investigational melanoma vaccine, seviprotimut-L, at ASCO20 virtual scientific program (PRNewswire) - P3, N=1,224; MAVIS (NCT01546571); Sponsor: Polynoma LLC; "Polynoma LLC...is presenting final analysis of clinical data from Part B1 of MAVIS (Melanoma Antigen Vaccine Immunotherapy Study)...at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program, to be held online May 29-31, 2020...Final analysis of subgroups confirmed the findings from the interim analysis, suggesting enhanced RFS for seviprotimut-L in patients with AJCC Stage IIB/IIC melanoma, particularly those under age 60, and those with ulceration, whose lesions are considered more serious because they have a greater risk of metastasis."

P3 data • Melanoma • Oncology • Solid Tumor

Polynoma presenting interim phase III data for its investigational melanoma vaccine, seviprotimut-L, at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Canada Newswire) - “Polynoma LLC…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...A multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in post-resection melanoma patients at high risk of recurrence...Karl D. Lewis, MD...Svetomir N. Markovic, MD, PhD; Omid Hamid, MD...Jose Lutzky, MD, FACP..."

P3 data