COSMIC-021 Trial Reveals Encouraging Safety and Efficacy in Urothelial Carcinoma


Sumanta K. Pal, MD, discusses the safety and efficacy results of the COSMIC-021 clinical trial.

Sumanta K. Pal, MD, professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Kidney Cancer Program at City of Hope Comprehensive Cancer Center, discusses the safety and efficacy results of the COSMIC-021 clinical trial (NCT03170960).

In the multicenter, open-label trial the combination of atezolizumab (Tecentriq), and cabozantinib (Cabometyx) is being examined in patients with metastatic urothelial carcinoma (UC).

According to Pal, a total of 3 patients, 1 patient in cohort 3 and 2 in cohort 4, had complete responses while 5 patients in cohort 3, 7 in cohort 4, and 3 patients in cohort 5 achieved partial responses, respectively. The objective response rates demonstrated in the trial were 20%, 30%, and 10%, and the disease control rates were 80%, 63%, and 61%.

Overall, atezolizumab with cabozantinib demonstrated encouraging clinical activity with manageable toxicity when used as treatment in this patient population.


0:08 | In terms of efficacy, we determined that the response rate was 30%, 20%, and 10%, across the 3 cohorts ranging from cisplatin-eligible to ineligible to immune checkpoint inhibitor pretreated. In terms of some of the other data that we presented at the meeting, we have the median duration of response that we're reporting out within this cohort, which was 7.1 months amongst those patients that were cisplatin-ineligible, and 4.1 months in those that have received prior immune checkpoint inhibitors. This is what's really compelling. The median duration of response was not reached in those both patients that were cisplatin eligible. It is going to be interesting to see how that pans out.

0:49 | We saw that the vast majority of patients of a cohort had some degree of tumor shrinkage with a combination irrespective of the cohort. In terms of progression free survival [PFS], the PFS in the cisplatin eligible cohort was 7.8 months. In the cisplatin ineligible cohort, it was 5.6 months. In terms of safety and tolerability, I thought that there weren't any unusual signals that you wouldn't expect from a caveat and that based immunotherapy combination. We have seen that data and renal cell, hepatocellular, and other diseases, so nothing that really stood out in my mind.

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