On February 28, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported interim results from its Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s (Press release, Heat Biologics, FEB 28, 2018, View Source [SID1234524236]).
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anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers have progressed after treatment with one or more lines of therapy.
Among the 35 patients in the Intent-to-Treat ("ITT") population, 6 patients (17%) achieved a partial response and 14 patients (40%) achieved disease control. Evaluable ITT patients (those who underwent at least one follow-up scan regardless of treatment duration) demonstrated overall response and disease control rates of 26% and 67%, respectively. Overall responses appeared durable and long lasting. The survival data are still maturing, and median overall survival has not yet been reached. The combination of HS-110 and nivolumab was well tolerated, with no additional toxicities compared to what has been observed with single agent checkpoint inhibitors.
As predefined in the clinical protocol, patient subgroups were evaluated for levels of tumor infiltrating lymphocytes ("TIL") and for PD-L1 checkpoint protein expression on tumor cells. Four of 9 "cold tumor" patients with low TIL levels (<10%) at baseline had partial responses. HS-110 also showed a durable effect in patients with low levels of PD-L1, with 3 of 9 patients responding. Both of these patient populations respond poorly to checkpoint inhibitors.
George Peoples, M.D., Chief Medical Officer, stated, "The results from this combination trial with HS-110 and nivolumab are very promising, demonstrating durable responses in those patients with low levels of TIL and PD-L1. These patients represent the most difficult-to-treat patient groups and comprise the majority of the NSCLC population."
"We look forward to continuing patient enrollment to better define the optimal NSCLC population and inform the design of a pivotal trial," commented Jeff Wolf, Chairman and CEO. "These data are consistent with the mechanism of action of our T-cell Activation Platform that promotes a robust T-cell immune response, an important component of an effective immunotherapy combination against cancer."
DURGA Trial Design
The ongoing DURGA trial is a single arm multicenter trial that was designed to evaluate the combination of HS-110 and nivolumab in patients with NSCLC. Patients with advanced and previously treated NSCLC were treated with weekly HS-110 for 18 weeks and nivolumab 3 mg/kg every 2 weeks until disease progression or death. The primary endpoints are 1) safety and tolerability, and 2) objective response rate as defined by RECIST 1.1 criteria. Secondary endpoints include disease control rate, duration of response, peripheral blood immune response, progression-free survival and overall survival.
Live Webcast with Slides
The interim data from the DURGA trial will be presented at an analyst event, taking place at 8am Eastern Time, today, Wednesday February 28th. To register and watch a live webcast of the event, visit View Source