SELLAS Life Sciences (Nasdaq:SLS) a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced the completion of enrollment for a Phase 2 independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS) targeting high-risk, high-expression HER2-positive (IHC3+) breast cancer patients.

As quoted in the press release:

 This trial enrolled 100 patients and top-line data are expected in the fourth quarter of 2019.  SELLAS recently reported positive data from a separate Phase 2b study of trastuzumab +/- NPS in low-expression HER2 (IHC 1+/2+) or triple negative breast cancer patients whose tumors are also identified by low-to-no expression of hormone receptors.

This trastuzumab + NPS clinical study is a multi-center, prospective, randomized, single-blinded investigator-sponsored Phase 2 trial focusing on patients with a diagnosis of HER2-positive (immunohistochemistry [IHC] 3+ and/or HER2 FISH-amplified) breast cancer who are HLA-A02, A03, A24 or A26-positive and at high-risk for recurrence after standard therapy for early-stage disease.  Eligible patients were randomized to receive NPS plus trastuzumab or trastuzumab alone in the adjuvant setting to prevent or delay disease recurrence. The primary endpoint of the study is disease-free survival (DFS). Support for this trial is provided, in part, by the Congressionally Directed Medical Research Program (CDMRP), funded through the Department of Defense via a Breast Cancer Research Program Breakthrough Award to Elizabeth Mittendorf, MD, PhD.  The National Breast Cancer Coalition led the effort to establish the CDMRP to enhance the funding for breast cancer research and remains integrally involved in the grant selection process.

Click here to read the full press release.