GU Cancers 2021 | CheckMate 9ER: cabo-nivo superior to sunitinib in extended follow-up results
Andrea Apolo, MD, National Cancer Institute, Bethesda, MD, gives an overview of the extended follow-up results from the Phase III CheckMate 9ER study (NCT03141177) trialling first-line cabozantinib plus nivolumab (cabo-nivo) versus sunitinib for advanced renal cell carcinoma (aRCC). At a median follow-up of 24 months, cabo-nivo showed superior efficacy over sunitinib with a progression-free survival (PFS) of 17 months versus eight months. In an exploratory subgroup analysis of patients with sarcomatoid rCC, the PFS was 10.3 months with cabo-nivo, with overall survival (OS) not reached, versus a PFS of 4.2 months and an OS of 19.7 months for sunitinib. This interview took place during the 2021 Genitourinary Cancers Symposium.
Transcript (edited for clarity)
Speaking of the CheckMate-9ER study, this is another study that we’re presenting this year at GU ASCO 2021. And this is a Phase III trial of first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma, which was initially presented at ESMO 2020 and showed that the cabozantinib and nivolumab combination was superior to sunitinib, with a median follow-up of 18 months...
Speaking of the CheckMate-9ER study, this is another study that we’re presenting this year at GU ASCO 2021. And this is a Phase III trial of first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma, which was initially presented at ESMO 2020 and showed that the cabozantinib and nivolumab combination was superior to sunitinib, with a median follow-up of 18 months.
So, we now report the key efficacy and safety outcomes of cabo-nivo versus sunitinib with a longer follow-up of 24 months and an exploratory subgroup analysis in patients with sarcomatoid renal cell carcinoma. With a longer follow-up, we see that in the 651 patients that were randomized to receive cabo-nivo versus sunitinib, cabo-nivo continues to show superiority to sunitinib in terms of progression-free survival, with a progression-free survival benefit of 17 months versus 8 months for the sunitinib arm with a hazard ratio of 0.52. The overall survival was not reached in the cabo-nivo arm but it was 29 months for the sunitinib arm, with a hazard ratio of 0.66.
And when we look at the sarcomatoid arm, the progression-free survival of cabo-nivo was 10.3 months versus 4.2 months for sunitinib. And the overall survival was not reached for cabo-nivo, and it was 19.7 months for the sunitinib arm. So, in conclusion, with this longer follow-up, cabo-nivo still appears to be superior to sunitinib. And based on the findings that were initially presented at ESMO 2020 on January 22, 2021, the FDA granted FDA approval to the combination of cabozantinib and nivolumab for the first-line treatment of renal cell carcinoma.
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