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Data Safety Monitoring Board Confirms Triple Negative Breast Cancer as the Target Patient Population for Development of NeuVax™ (nelipepimut-S) in Combination with Trastuzumab (Herceptin®) in HER2 1+/2+ Breast Cancer Patients Following Final Analysis of P
Data Safety Monitoring Board met on October 15, 2018 for final analysis
Interim and final results of the Phase 2b study to be presented on Monday, October 22, 2018 during an oral presentation at the European Society for Medical Oncology (ESMO) 2018 Annual Meeting
Conference Call on October 22, 2018 at 8:00 a.m. ET
NEW YORK, Oct. 19, 2018 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group Inc., (Nasdaq: SLS) (SELLAS or the Company), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, today announced that the independent Data Safety Monitoring Board (DSMB) unanimously concluded that the final data from the Phase 2b study of trastuzumab (TZ, Herceptin®) +/- nelipepimut-S (NPS, NeuVax™) in HER2 1+/2+ breast cancer patients confirms the previously announced findings from the interim analysis of this study. The DSMB concluded that there was an incremental improvement in the outcomes and statistics with a longer median follow-up (more than 7 months; 26.1 months at final vs. 18.8 months at interim analysis). The final analysis showed no new safety signals and continued to show no difference in cardiotoxicity between TZ + NPS compared to TZ alone. Finally, the DSMB confirmed that the final analysis continues to identify patients with triple negative breast cancer (TNBC) as the key target patient population for development of the NPS + TZ combination in the adjuvant setting in early-stage HER2 1+/2+ breast cancer patients.
On March 28, 2018, based on a pre-specified interim analysis and the positive TNBC results, the DSMB had recommended to expeditiously seek regulatory guidance by the U.S. Food and Drug Administration (FDA) for further development of the combination of NPS + TZ in TNBC, a population with large unmet medical need.
SELLAS will host a conference call at 8:00 a.m. ET on October 22, 2018, following the oral presentation at the ESMO 2018 Annual Meeting of the interim and updated final clinical data from its Phase 2b trial of the combination of trastuzumab (Herceptin®) +/- nelipepimut-S (NPS, NeuVax™) targeting HER2 low-expressing breast cancer patient cohorts. Management and invited Key Opinion Leaders, Dr. Elizabeth Mittendorf, MD, PhD and Dr. George Peoples, MD, FACS, will participate in the conference call.
Conference Call Details for Monday, October 22, 2018 at 8:00 a.m. ET:
To participate in the conference call, please dial (866) 416-7995 (domestic) or +1 (409) 217-8225 (international) and refer to conference ID 5571389. A live webcast of the call can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.sellaslifesciences.com.
An archived webcast recording will be available on the SELLAS website beginning approximately two hours after the call.
Details for the ESMO presentation are as follows:
Title: 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
Date and Time: 22 October, 2018; 11:54 am Central European Time (5:54 am ET)
Location: Hall A2 - Room 18; Messe Munich Congress Venue, Munich, Germany
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.
The European Society for Medical Oncology (ESMO) is Europe’s leading non-profit medical oncology organization. ESMO is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO 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 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.”
About SELLAS Life Sciences Group, Inc.
SELLAS is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS has Phase 3 clinical trials planned (pending funding availability) for GPS in two indications, acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM), and is also developing GPS as a potential treatment for multiple myeloma (MM) and ovarian cancer. SELLAS plans to study GPS in up to four additional indications. SELLAS has received Orphan Drug designations for GPS from both the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) for AML, MPM, and MM; GPS also received Fast Track designation for AML and MPM from the FDA. SELLAS’ second product candidate, NeuVax™ (nelipepimut-S), is a HER2-directed cancer immunotherapy being investigated for the prevention of the recurrence of breast cancer after standard of care treatment in the adjuvant setting. NeuVax™ has received Fast Track status designation by FDA for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care.
For more information on SELLAS, please visit www.sellaslifesciences.com.
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements, include, without limitation, statements related to the results of clinical studies and as to further development of nelipepimut-S (NeuVax™) for breast cancer. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in Exhibit 99.1 in its Current Report on Form 8-K filed on July 18, 2018 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Stern Investor Relations, Inc.
David Moser, JD
SELLAS Life Sciences Group, Inc.