On November 20, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), reported additional positive Phase 2 interim top line data from Cohort A 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) at a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy on November 19, 2019 available at View Source (Press release, Heat Biologics, NOV 20, 2019, View Source [SID1234551518]). Cohort A enrolled only previously treated patients who have never received a checkpoint inhibitor (CPI).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Company reported median overall survival (mOS) of 16.9 months with 50% of patients censored with median follow up of 17 months. This compares favorably to the 12.2 months mOS reported in the Checkmate 057[i] study with Bristol-Myers Squibb’s nivolumab (Opdivo) alone in a similar patient population. The Company also reported an objective response rate (ORR) per iRECIST of 22%, and a disease control rate (DCR) of 48%, with tumor shrinkage observed in 46% of patients.
Moreover, mOS of patients experiencing dermal injection site reactions (ISR) was 42.1 months. Statistically significant improvement in progression-free survival (PFS) and mOS was observed compared to those without ISR (Hazard Ratio = 0.51, p=0.042 and Hazard Ratio = 0.14, p <0.0001, respectively).
Jeff Hutchins, Ph.D., Heat’s Chief Scientific and Operating Officer commented, "The data from Cohort A is extremely encouraging and builds upon our recently announced data in Cohort B, a population consisting of patients who previously progressed on a checkpoint inhibitor and were re-challenged with HS-110 plus nivolumab. Of special interest in Cohort A is a prospectively defined subset of PD-L1 positive patients who achieved a median overall survival of 42.1 months (95% CI; 15.8 – 42.1). This is particularly compelling when compared to overall survival rates in published literature of 1st or 2nd line checkpoint inhibitor monotherapy."
Highlights for Cohort A patients are presented below:
Median Overall Survival of 16.9 months (50% of patients still alive with median follow up of 17 months)
Median overall survival of ISR positive patients was 42.1 months (95% CI; 15.8 – 42.1) vs. an ISR negative mOS of 5.9 months (95% CI; 1.4 – 11.6) (Hazard Ratio = 0.14, p <0.0001)
A prospectively defined analysis of PD-L1 negative vs. PD-L1 positive showed a difference in mOS of 16.9 months (95% CI; 5.5 – unk) to 42.1 months (95% CI; 1.6 – 42.1), respectively
Objective Response Rate by iRECIST of 22% and DCR of 48%
Tumor shrinkage in 46% of patients
Patients who achieved stable disease or better showed statistically significant decreases in peripheral blood T cell subsets from baseline while on combination treatment
Jeff Wolf, Heat’s CEO, commented, "We are strongly encouraged by this latest data release and believe the data from both Cohorts A and B will be helpful as we advance partnership and collaboration discussions."