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Phase 1b trial of HS-110, nivolumab combination meets efficacy endpoint in NSCLC
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The phase 1b trial designed to evaluate HS-110 in combination with nivolumab for the treatment of non–small cell lung cancer met its efficacy endpoint and will advance into a phase 2 trial, according to the drug’s manufacturer.
HS-110 (viagenpumatucel-L, Heat Biologics) uses lung cancer cells modified by “ImPACT” therapy — or Heat Biologics’ proprietary off-the-shelf Immune Pan-Antigen Cytotoxic therapy, an engineered cell line designed to express a version of the naturally occurring gp96 heat-shock protein— to stimulate a patient’s immune system to activate a cytotoxic T cell response against a range of antigens associated with NSCLC.
“We are encouraged by the results from this phase 1b trial evaluating the therapeutic
vaccine, HS-110, combined with the checkpoint inhibitor, nivolumab (Opdivo, Bristol-Myers Squibb), in patients with advanced NSCLC,” Daniel Morgensztern, MD, associate professor of medicine and director of thoracic oncology at Washington University School of Medicine, said in a Heat Biologics–issued press release. “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 after treatment, and anticipate that we can confirm this trend in the phase 2 [trial].”
Of the 15 patients treated with the combination, five demonstrated a 20% or greater tumor reduction.
Eight patients with increased levels of tumor infiltrating lymphocytes at 10 weeks showed a durable benefit. Six of those patients were alive at 1-year follow-up.
The Data Monitoring Committee of the phase 1b study determined the safety endpoint was met and no additional toxicities observed with the combination compared with existing data of nivolumab monotherapy.
“We are pleased with the Data Monitoring Committee’s decision to expand the trial to a phase 2 [trial] given the positive clinical responses seen to-date,” Jeff Hutchins, PhD, chief scientific officer and senior vice president of preclinical development at Heat Biologics, said in the release.
“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,” Hutchins added. “Although this is a small sample size and a nonrandomized 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.”