On March 13, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, reported that the company achieved the efficacy endpoint for its Phase 1b trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for the treatment of non-small cell lung cancer (NSCLC) and that the trial met the expansion criteria to advance into a Phase 2 (Press release, Heat Biologics, MAR 13, 2017, View Source [SID1234518090]).

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In reviewing the Phase 1b data, the Data Monitoring Committee (DMC) determined that the Phase 1b safety endpoint was met and that there do not appear to be additional toxicities seen in the HS-110/nivolumab combination compared to existing data on nivolumab alone. Furthermore, 5 out of 15 patients treated with the HS-110/nivolumab combination had 20% or greater tumor reduction. The DMC concluded that the positive safety profile, mechanistic evidence and encouraging signs of synergistic efficacy warranted expansion to a Phase 2 trial.

"We are encouraged by the results from this Phase 1b trial evaluating the therapeutic vaccine, HS-110, combined with the checkpoint inhibitor, nivolumab, in patients with advanced non-small cell lung cancer," said Daniel Morgensztern, M.D., Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine. "We continue to see that the combination appears to be generally well-tolerated, and the encouraging signs of efficacy warrant a larger sample size. We’ve seen some patients with increased tumor infiltrating lymphocytes (TIL) after treatment, and anticipate that we can confirm this trend in the Phase 2."

"We are pleased with the DMC’s decision to expand the trial to a Phase 2 given the positive clinical responses seen to-date. We saw that those patients with increased levels of TIL at 10 weeks had a durable benefit, with six out of eight of these patients (75%) alive at the one-year follow-up point," said Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "We designed this trial with the Bristol-Myers Squibb Checkmate 057 nivolumab trial in mind, which reported a 19% response rate in a similar patient population. Although this is a small sample size and a non-randomized trial, we believe that this is an encouraging sign that the combination may be more effective than checkpoint therapy alone and could provide therapeutic benefit to a majority of lung cancer patients who do not respond well to checkpoint monotherapy. We remain focused on enrolling new patients to better characterize the objective response rate, durability of the response and associated immune activity."