Exelixis Announces Detailed Results From Late-Stage Cabometyx Combo Trial In Kidney Cancer

Exelixis Inc EXEL announced detailed results from the COSMIC-313 Phase 3 trial cabozantinib (Cabometyx), nivolumab, and ipilimumab combo in untreated advanced renal cell carcinoma (RCC) patients.
The data are being presented at the 2022 European Society of Medical Oncology (ESMO) Congress.
As previously announced, the cabozantinib combination significantly reduced the risk of disease progression or death compared with the combination of nivolumab and ipilimumab.
The cabozantinib combination versus the combination of nivolumab and ipilimumab did not demonstrate a significant benefit in overall survival (OS). Therefore, the trial will continue to the next analysis of OS.
The median progression-free survival (PFS) was not reached for the combination of cabozantinib, nivolumab, and ipilimumab and was 11.3 months for the nivolumab + ipilimumab combo.
Objective response rates in the PFS intent-to-treat population were 43% and 36%, respectively. The median duration of response was not reached in either treatment arm. PFS subgroup analyses will also be presented at the ESMO meeting.
The safety profile observed in the trial reflected the known safety profiles for every single agent and the combination regimens used in this study. No new safety signals were identified.
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