Checkpoint Therapeutics Announces Initiation of CONTERNO Phase 3 Trial of Cosibelimab Combined With Chemotherapy in Patients With First-Line Non-Squamous Non-Small Cell Lung Cancer

Checkpoint Therapeutics, Inc. recently announced the initiation of the CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC). The primary endpoint for the CONTERNO Phase 3 trial is overall survival (OS), and the study is designed to support full regulatory approvals worldwide.

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said “We are excited to develop this combination in NSCLC, with the goal of extending the lives of patients with lung cancer and providing expanded access and fewer obstacles to potentially life-saving immunotherapy treatment. Our strategy since our founding has been to enter the largest markets in this class with a focus on highly competitive pricing, and there is no more impactful indication to execute on this approach than NSCLC with approximately 1.7 million new worldwide cases reported in 2020.”

The CONTERNO study (ClinicalTrials.gov, NCT04786964) is a Phase 3, open-label, multi-center, randomized trial investigating cosibelimab (1200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum chemotherapy (either carboplatin or cisplatin) versus pemetrexed and platinum chemotherapy alone in patients with previously untreated stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is OS. Key secondary endpoints include progression-free survival, objective response rate and safety. Approximately 560 subjects will be randomized in a 2:1 ratio to receive cosibelimab in combination with chemotherapy or chemotherapy alone.

Lung cancer is the most common cancer worldwide according to the World Health Organization, accounting for more than 2 million new cases diagnosed each year. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer diagnoses, resulting in approximately 1.7 million new cases each year. Currently, the 5-year survival rate for lung cancer is less than 20%, decreasing further when the disease is diagnosed at later stages. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease. Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25% of all cancer deaths.

Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to support one or more applications for marketing approval. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (EGFR) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. For more information, visit www.checkpointtx.com.