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Thomas Flaig, MD


ASCO 2022: COSMIC-021 Cohorts of Cabozantinib Plus Atezolizumab in Urothelial Cancer

By: Vanessa A. Carter, BS
Posted: Monday, June 20, 2022

Sumanta K. Pal, MD, FASCO, of the City of Hope Comprehensive Cancer Center, Duarte, California, and colleagues conducted a phase Ib study to assess an anti–PD-L1 therapy combination of cabozantinib and atezolizumab in patients with inoperable, locally advanced or metastatic urothelial carcinoma. Presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4504), the results of cohorts 3, 4, and 5 of the COSMIC-021 trial focused on the combination’s safety and efficacy.

“Cabozantinib and atezolizumab demonstrated encouraging clinical activity with manageable toxicity in inoperable locally advanced/metastatic urothelial carcinoma as first-line systemic therapy in cisplatin-based chemotherapy eligible/ineligible patients, and as second- or later line in patients who received prior immune checkpoint inhibitors,” concluded the investigators.

This trial enrolled 30 patients in each cohort (C3, C4, and C5) who had inoperable, locally advanced or metastatic urothelial carcinoma with transitional cell histology. Participants in C3 and C4 received no prior therapy and were ineligible for cisplatin-based chemotherapy; those in C5 received one prior immune checkpoint inhibitor. Individuals were administered 40 mg of cabozantinib orally and 1,200 mg of atezolizumab intravenously.

The median patient age was 74 years in C3, 66 years in C4, and 68 years in C5. In C3, C4, and C5, 63%, 57%, and 74% of participants demonstrated an Eastern Cooperative Oncology Group performance status of 1, 33%/17%, 40%/20%, and 58%/23% experienced lung/liver metastasis, and 67%, 70%, and 71% had the bladder as a primary tumor site, respectively.

The median follow-up was 27.9 months in C3, 19.1 months in C4, and 32.9 months in C5; one, six, and one patient remained on treatment. The most common treatment-related adverse events of any grade included nausea, diarrhea, decreased appetite, and fatigue. Furthermore, grade 3 or 4 treatment-related adverse events occurred in 63%, 43%, and 45% of individuals in C3, C4, and C5.

Disclosure: For full disclosures of the study authors, visit

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