SELLAS Life Sciences Group, Inc. announced follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo®) in patients with refractory/relapsed malignant pleural mesothelioma (MPM). As previously reported, ten patients were enrolled in the clinical study and nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response.

All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional analyses for the correlation of immune response and survival benefit were performed. Immune response was defined as a measurable increase in activated Wilms Tumor 1 (WT1) specific T cells, both CD8 T+ cells (killer T cells) and CD4+ T cells (regulatory T cells).

Of the 10 evaluable patients, eight were male and two were female, with a median age of 69 years. 60% entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients).

All patients had MPM epithelioid and/or sarcomatoid variant, a tumor that universally expresses WT1, one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy. The key clinical efficacy and immune response study outcomes are as follows: 70.3 weeks (17.6 months) median overall survival (OS) was achieved in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all 10 patients (nine patients with combination therapy and one GPS-only patient). Median OS for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months).

OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40% of patients). The median OS among patients who did not have an immune response to GPS was 9.0 months; the median OS for patients who had an immune response to GPS was 27.8 months, more than three times longer median OS (208.3% increase). Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS.

Three patients had both CD4+ and CD8+ immune responses (33.3%). Among patients who had a full immune response (both CD4+ and CD8+) to GPS, two patients achieved an objective response (66.7%), while among the patients who did not have an immune response to GPS one patient achieved an objective response (14.3%). 11.9 weeks median progression-free survival (PFS) was observed for all patients.

The disease control rate (DCR) was 30% with three patients achieving stable disease per RECIST criteria with a tumor volume decrease of up to 17%. DCR is the sum of the overall response rate and rate of stable disease.