Phase III CONTACT-03 Trial of Atezolizumab Plus Cabozantinib Fails to Meet Primary Endpoint in Renal Cell Carcinoma

On March 2, Exelixis announced that the Phase III CONTACT-03 study evaluating Roche's PD-L1 antibody atezolizumab in combination with cabozantinib for patients with locally advanced or metastatic clear cell or non-clear cell renal cell carcinoma (RCC) did not meet one of the co-primary endpoints of progression-free survival (PFS).

According to the PharmaCube database, atezolizumab has not yet been approved for RCC indications. However, the tyrosine kinase inhibitor cabozantinib was approved by the FDA as a second-line treatment for advanced RCC in 2016 and gained approval for first-line treatment of advanced RCC in 2017. In January 2021, the FDA approved cabozantinib in combination with the PD-1 antibody nivolumab for first-line treatment of RCC.

CONTACT-03 is a randomized, open-label Phase III study that enrolled 522 patients. The study aims to evaluate the efficacy and safety of atezolizumab in combination with cabozantinib compared to cabozantinib monotherapy in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) RCC whose disease progressed during or after treatment with immune checkpoint inhibitors. The primary endpoints of the study include PFS and overall survival (OS).

In addition to not achieving the primary endpoint of PFS, Exelixis stated that the safety profile of atezolizumab in combination with cabozantinib observed in the CONTACT-03 study was consistent with the known safety profiles of each monotherapy, with no new safety signals identified.

Notably, just three months ago, Exelixis disclosed similarly disappointing results from the Phase III CONTACT-01 study. Compared to chemotherapy, the combination therapy of atezolizumab and cabozantinib failed to provide significant OS benefit for previously treated patients with metastatic non-small cell lung cancer.

The CONTACT-02 study aims to evaluate the therapeutic potential of this combination in metastatic castration-resistant prostate cancer, and Exelixis is expected to announce the results this year.

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