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GU Cancers 2021 | Cabo-nivo or cabo-nivo-ipi for metastatic genitourinary tumors

Andrea Apolo, MD, National Cancer Institute, Bethesda, MD, gives an outline of the final results from a Phase I trial (NCT02496208) and expansion cohorts of cabozantinib and nivolumab alone (cabo-nivo) or with ipilimumab (cabo-nivo-ipi) for metastatic genitourinary tumors at ASCO GU 2021. 120 patients were enrolled in the study. The ORR was 38% with 11.1% of patients achieving complete responses and 26.9% achieving partial responses. The median duration of response was 22.8 months. The therapy showed particular efficacy in renal cell carcinoma. This data has informed trials including CheckMate 9ER (NCT03141177), COSMIC 313 (NCT03937219), PDIGREE (NCT03793166) and ICONIC (NCT03866382). This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

This year at GU ASCO 2021, we present the final results of the Phase I trial and expansion cohort of cabo-nivo and cabo-nivo-ipi for patients with genital urinary tumors. Preclinical work done with cabozantinib and urothelial cancer cell lines, and tumor xenografts demonstrated that the MET HGF pathway may be important in urothelial carcinoma. And that led to a Phase II study of cabozantinib monotherapy in patients with bladder cancer...

This year at GU ASCO 2021, we present the final results of the Phase I trial and expansion cohort of cabo-nivo and cabo-nivo-ipi for patients with genital urinary tumors. Preclinical work done with cabozantinib and urothelial cancer cell lines, and tumor xenografts demonstrated that the MET HGF pathway may be important in urothelial carcinoma. And that led to a Phase II study of cabozantinib monotherapy in patients with bladder cancer. And within that study, we saw that cabozantinib had monotherapy activity, and that it also may modulate immune subsets, providing a rationale for combining cabozantinib with immunotherapies such as nivolumab and nivolumab-ipilimumab. And that led to the Phase I study that I’m presenting today at GU ASCO 2021 of cabo-nivo and cabo-nivo-ipi. And I present not only the Phase I dose escalation study of the first 54 patients, but also the additional seven expansion cohorts for a total of 120 patients.

And what we saw is an overall response rate of 38%, in a heterogeneous group of patients with genital urinary tumors, including very rare tumors with an 11% complete response. And the median duration of response was 23 months, and the time to response was two months. And when we look at it by tumor type, the overall response rate for patients with renal cell carcinoma, including sarcomatoid patients is an overall response rate of 42%, and in patients with urothelial carcinoma.

So, the overall response rate that we saw for the entire cohort was 38% for all patients with a complete response rate of 11%. And remember, this is a very heterogeneous group of patients with genital urinary tumors, the median duration of response was 23 months and the time to response was two months. And if we look at it by tumor type, the renal cell carcinoma patients, the overall response rate was 63%. And this included patients with sarcomatoid histology and for bladder cancer patients, advanced bladder cancer patients, the overall response rate was 42% with 21% of patients achieving a complete response.

And we also saw activity in rare tumors, such as adenocarcinoma of the bladder, uracil squamous cell carcinoma of the bladder, small cell carcinoma of the bladder, penile cancer, renal medullary carcinoma, and chromophobe renal cell carcinoma. And actually, the safety and preliminary activity that we saw in the renal cell carcinoma, in patients with renal cell carcinoma and rare GU tumors informed the development of several Phase III trials, including the CheckMate 9ER, the COSMIC 313 Study, and the Alliance PDIGREE Study, and renal cell carcinoma, and the Alliance ICONIC Phase II study in rare GU tumors.

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