On July 23, 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 that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/-nelipepimut-S (NeuVax) will be presented as a Proffered Paper in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Sellas Life Sciences, JUL 23, 2018, View Source;Herceptin-at-Upcoming-European-Society-for-Medical-Oncology-ESMO-2018-Meeting/default.aspx [SID1234527830]).
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The abstract, "Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients," describes research undertaken at Cancer Insight, LLC by a team of clinicians-scientists led by COL (ret) George E. Peoples, MD, FACS, the principal investigator for the study.
Data will be presented from a prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of Herceptin +/- NeuVax in HER 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences. As previously announced, a pre-specified interim analysis of safety and efficacy conducted by the study independent data safety monitoring board (DSMB), demonstrated a clinically meaningful and statistically significant difference between the TNBC cohort of patients and the control arm with a hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax + Herceptin combination compared to Herceptin alone. The analysis also showed an adverse event profile with no notable differences between treatment arms and no additional cardiotoxicity in the NeuVax + Herceptin arm. Based on these positive results, the DSMB recommended to expeditiously seek regulatory guidance from the U.S. Food and Drug Administration for further development of the combination of NeuVax + Herceptin in TNBC, a population with a large unmet medical need.
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.
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The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care".