Sellas Life Sciences Group Inc. (NASDAQ:SLS) recently announced that the Data Safety Monitoring Board (DSMB) accepted the Phase 2b study data of Trastuzumab confirming the findings previously announced from the interim analysis of this study. SLS is a biopharmaceutical company engaged in performing clinical-stage research and developing novel cancer immunotherapies for a wide range of cancer indications. The company is currently studying the effect of trastuzumab in breast cancer patients.
Final Phase 2b study of Trastuzumab analysis shows no new safety signals
According to DSMB, the outcomes revealed incremental improvement with longer median follow-up statistics. The final analysis shows no new safety signals or even a small difference in cardiotoxicity when it compared TZ+ NPS to TZ alone. DSMB concluded that the Phase 2b study’s final analysis identifies the patients suffering from triple negative breast cancer (TNBC) as the major target patient population who can develop NPS + TZ combination.
On March 28 this year DSMB recommended SLS to seek regulatory guidance for its Phase 2b study of Trastuzumab from the U.S. Food and Drug Administration (FDA) so that the study can further develop the NPS + TZ in TNBC combination. DSMB made this recommendation on the basis of the positive TNBC results and a pre-specified interim analysis.
SLS announced Phase 2b nelipepimut-S combination clinical trial data
Apart from announcing the final data for Phase 2b study data of Trastuzumab, the company recently also announced the data from its single-blinded, randomized, prospective and controlled Phase 2b nelipepimut-S combination clinical trial data. The combination targets HER2 low-expressing cohorts of breast cancer patients. The company presented the data in an oral presentation in Munich, Germany at the European Society of Medical Oncology (ESMO) 2018 Annual Meeting.
In his annual meeting address, President and Chief Executive Officer of SELLAS Dr. Angelos Stergiou, MD, ScD h c, said, “These data presented at ESMO today highlight the therapeutic potential of NPS for patients with early-stage triple negative breast cancer (TNBC), who currently face limited and ineffective treatment options in the adjuvant setting.”