On November 11, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that the Company presented additional positive Phase 2 interim top line data from Cohort B of the Company’s Phase 2 trial of its T-cell activating cell-based therapy, HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, NOV 11, 2019, View Source [SID1234550861]). The data was presented at a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 8th.
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Cohort B enrolled patients who had previously received a minimum of 4 months of checkpoint inhibitor (CPI) therapy and whose disease had subsequently progressed, a patient population with a significant unmet medical need. 61% of patients achieved disease stabilization per iRECIST. Median progression-free survival was 3.2 months and median overall survival was 11.8 months. Moreover, patients experiencing dermal injection site reactions (ISR) had statistically significant improvement in PFS and OS compared to those without ISR (Hazard Ratio = 0.40, p=0.0068 and Hazard Ratio = 0.16, p=0.0005, respectively).
George Peoples, M.D., FACS, Heat Biologics’ Chief Medical Advisor, commented, "This data is extremely promising, as the combination of HS-110 and nivolumab may provide patients with treatment options other than salvage cytotoxic chemotherapy. Consistent with our previously reported data, the benefit of HS-110 in combination with nivolumab is independent of PD-L1 expression and we are seeing positive data in low PD-L1 patients (<1%) that typically do not respond well to checkpoint inhibitor monotherapy."
Dr. Peoples continued, "This data suggests re-challenging the immune system with nivolumab and HS-110 after checkpoint inhibitor treatment failure may restore responsiveness and clinical benefit. Further supporting the mechanism of action of HS-110, patients experiencing dermal injection site reactions (ISR) had statistically significant improvement in PFS and OS compared to those without ISR."
This combination of HS-110 and nivolumab is well-tolerated and when compared to CPI monotherapy, no increase in the incidence of immune-related adverse events has been observed.
Jeff Wolf, Heat Biologics’ CEO, commented, "This data is very encouraging as the combination of HS-110 with nivolumab may address an important unmet need among patients whose disease has progressed following checkpoint inhibitor therapy. These patients currently have limited treatment options. We look forward to advancing our clinical trials and exploring potential partnership and other strategic options to move this program forward."