On November 9, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported data from a preplanned secondary efficacy analysis across human leukocyte antigen (HLA) allele subgroups from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S (NeuVax, NPS) +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patient cohorts (Press release, Sellas Life Sciences, NOV 9, 2018, View Source [SID1234531195]). The data are being presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 7 -11, 2018.
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The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. In the subgroup of triple negative breast cancer (TNBC) patients with the HLA-A24+ allele type, which is highly prevalent in the Asian population, treated with the combination of NPS and trastuzumab (n=47), the p-value is 0.003 with a 90.6% relative reduction in risk of relapse or death at 24 months and a hazard ratio of 0.08 in favor of the active (combination) arm.
"These data not only confirm the clinical effect of the NPS plus trastuzumab combination in TNBC, which we recently announced at ESMO (Free ESMO Whitepaper) with a p-value of 0.013 and a 75% relative reduction in the risk of relapse or death, but also positions NPS biologically as an agent that could potentially be used globally, considering the high prevalence of the HLA-A24 allele in populations across the Pacific basin and Asia. We are scheduled to meet with the U.S. regulatory authorities in December 2018 on the most optimal and expeditious development path for NPS in TNBC, and continue to advance ongoing interactions with potential partners," said Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
"In this preplanned secondary efficacy analysis, consistent positive clinical benefit was seen in the TNBC cohort, irrespective of patients’ HLA allele types in favor of the NPS plus trastuzumab combination arm. Specifically, the HLA-A24+ TNBC patients had a significant improvement in disease-free survival both by log-rank and landmark (24 month) analysis despite the lowest predicted binding potential between the E75 (NPS) antigen and this HLA-type," commented Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study.
"This suggests that NPS, which is able to bind to the lower-affinity MHC-I conformations (A24) in addition to the high-affinity ones, i.e., A02 and A03, may generate an optimally favorable immunologic response, possibly due to decreased exposure and tolerance to the E75 epitope. This is important, as other peptide vaccines can be tolerogenic and lead to progressively diminishing immunogenicity over time, something we do not expect to see with NPS," continued Dr. Mittendorf.
Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.
SITC Presentation Information
Date: Friday, November 9th, 2018
Time: 12:45 p.m. to 2:15 p.m. and 6:30 p.m. to 8:30 p.m. ET.
Venue: SITC (Free SITC Whitepaper) 2018 Annual Meeting, Walter E. Washington Convention Center, Washington, DC
Location: Poster Hall E
Poster number: P159
Title: "Correlation between response and HLA type in a randomized phase IIb trial of NeuVax + trastuzumab in HER2 low-expressing breast cancer patients to prevent recurrence."
About SITC (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy and serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world and brings together all aspects of the cancer immunology and immunotherapy community in its annual meeting.