Checkpoint Therapeutics Announces Presentation of Updated Cosibelimab Lung Cancer Results at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting
November 09, 2020 at 08:00 AM EST
NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced updated interim results from the ongoing global, open-label, multicohort Phase 1 clinical trial of its anti-PD-L1 antibody, cosibelimab, in patients with advanced cancers, including a cohort of patients with previously untreated high PD-L1 expressing advanced non-small cell lung cancer (“NSCLC”). The updated interim results are being presented in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting being held virtually from November 9-14, 2020.
“The single-agent activity of cosibelimab in NSCLC is compelling, with the observed 44.0% objective response rate and 10.3-month median progression-free survival comparing favorably to the datasets generated in similar subjects from the PD-(L)1 therapies available today. Based on the strength of these results, we intend to initiate a Phase 3 registration-enabling trial evaluating cosibelimab in combination with chemotherapy in first-line, metastatic NSCLC patients,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint. “The annual market for PD-(L)1 therapies in NSCLC is approximately $10 billion and growing. If approved, we believe cosibelimab could capture meaningful market share as a lower-priced alternative to therapies currently available, and NSCLC is an ideal follow-on to our planned first indication of cutaneous squamous cell carcinoma, for which top-line results from an on-going registration-enabling trial are expected in the second half of 2021.”
Summary of NSCLC Data Presented at SITC:
As of the interim analysis, 25 patients with NSCLC were enrolled and evaluable for efficacy by investigator assessment with at least one post-baseline tumor assessment or discontinued treatment prior. Tumor response assessments are summarized in the table below.
Objective response rate = best overall response of complete response or partial response divided by the number of evaluable patients. 1Represents patients who discontinued study without a post-baseline tumor assessment.
At the time of analysis, 123 patients with advanced cancers had been treated with cosibelimab and were evaluable for safety. Cosibelimab appeared to be safe and well-tolerated with a potentially favorable safety profile as compared to anti-PD-1 therapies currently available. The most common treatment-related adverse events (“TRAEs”) included fatigue (n=19, 15.4%) and rash (n=17, 13.8%), with only 2 patients (1.6%) discontinuing treatment due to a TRAE. Grade ≥3 TRAEs occurred in only 6 patients (4.9%), most commonly anemia and fatigue (each n=2, 1.6%, grade 3 only).
A copy of the poster presentation is available on the Publications page of the Pipeline section of Checkpoint’s website, www.checkpointtx.com.
Additional information on the meeting can be found on the SITC website, www.sitcancer.org.
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