Exelixis Inc. (NASDAQ:EXEL) has announced the start of the third phase vital CONTACT-01 cabozantinib (CABOMETYX) study combined with atezolizumab in metastatic non-small cell lung cancer patients. The company is studying the combination in patients that have previously received immune checkpoint inhibitor treatment as well as platinum-containing therapy.
As part of the clinical trial partnership between the company and Roche, they are also planning two more third phase pivotal trials. The two trials will be in (CRPC, CONTACT-02) metastatic castration-resistant prostate cancer as well as (RCC, CONTACT-03) renal cell carcinoma.
Cabozantinib showing synergistic effects with atezolizumab
Gisela Schwab, the Exelixis Chief Medical Officer, indicated that survival rates in metastatic non-small cell lung cancer patients are low. He added that since almost 50% of the patients get diagnosed at advanced stages, it is important for the patient community to have new treatment alternatives. This will be helpful for patients that show progression after chemotherapy and immunotherapy.
The chief medical officer indicated that the company witnessed encouraging results in its COSMIC-021 trial from cohort seven. He said that this validates the growing preclinical as well as clinical evidence the cabozantinib can result in the added immune-permissive condition. This potentially results in synergistic or additive effects with ICIs like Atezolizumab. Gisela added that the company was looking forward to imminent results of the combination treatment in CONTACT-01 trial and other cancers in phase 3 studies.
COSMIC-021 informed the design of third phase study
The current COSMIC-021 trial results informed the design of the pivotal third phase study. The COSMIC-021 study is a phase 1b cabozantinib and atezolizumab study in multiple advanced solid tumors such as CRPC, RCC, and NSCLC. The company presented Preliminary results from the study in a group of patients having advanced NSCLC that had progressed following ICI treatment at the 2020 ASCO Virtual Scientific Program.
The CONTACT-01 will be a multicentre, open-label, randomized, global third phase study that will enroll around 350 patients. It will randomize patients 1:1 to the cabozantinib experimental arm in combination with atezolizumab and the docetaxel control arm.