Study Design of COSMIC-021 in Advanced Urothelial Carcinoma

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 methods and design of the COSMIC-021 study (NCT03170960).

Within his presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Pal focused on cohorts 3, 4, 5 enrolled within the multicenter, open-label, phase 1b, study. The main goals of the trial are to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of the combination of cabozantinib (Cabometyx) and atezolizumab (Tecentriq) across multiple tumor types, including advanced urothelial carcinoma (UC).

Those enrolled in these cohorts included patients with inoperable locally advanced/metastatic UC who had transitional cell histology and an ECOG performance status of 0‒1. In cohorts 3 and 4, patients were required to have no prior therapy with cohort 3 being cisplatin-based chemotherapy ineligible or and those in cohort 4 eligible. Further, patients enrolled in cohort 5 had 1 prior immune checkpoint inhibitor and no prior VEGFR-tyrosine kinase inhibitor therapy.

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0:08 | The study is designed to test the principle that targeted therapy and immunotherapy have synergy. We started with dose escalation cohorts to make sure that cabozantinib and atezolizumab are safe and combinable. Once we reached that, we expanded to multiple different disease types where we thought that the combination would have activity.

0:26 | We've already published our results in kidney cancer. We have data that we've presented already in prostate cancer [and] we have some data in platinum refractory bladder cancer. This represents some of the new data that we have for previously untreated bladder cancer, so I'm quite excited to share this with our ASCO audience.

0:44 | To enroll in this particular study, again, many different tumor types are included, but in the specific cohorts that we focused on at ASCO 2022, patients had to have cisplatin eligible status, cisplatin ineligible status, or have received a prior immune checkpoint inhibitor. These are patients with metastatic urothelial cancer. These are defined by the cisplatin eligibility as defined by conventional criteria.