medwireNews: The latest findings from the CheckMate 9ER trial show that the combination of nivolumab plus cabozantinib continues to offer superior survival to that of sunitinib for patients with treatment-naïve advanced renal cell carcinoma (RCC) after a median follow-up of 32.9 months.
The update published in The Lancet Oncology builds on the initial positive findings after a median follow-up of 18.1 months in the open-label phase 3 trial, explain Robert Motzer (Memorial Sloan Kettering Cancer Center, New York, USA) and co-authors.
They now report the results of a preplanned final analysis showing a median overall survival (OS) of 37.7 months for the 323 patients randomly assigned to receive nivolumab 240 mg every 2 weeks plus cabozantinib 40 mg/day. This was significantly longer than the median OS of 34.3 months for the 328 patients instead given sunitinib 50 mg/day, giving a hazard ratio (HR) for death of 0.70 in favor of the combination arm.
Moreover, an OS benefit with the combination treatment was noted among subgroups of patients with special characteristics, including those with sarcomatoid features, history of nephrectomy, and liver, bone, or lung metastases at baseline.
Progression-free survival (PFS) was also updated, to give a median duration of 16.6 months for patients given nivolumab plus cabozantinib versus 8.3 months for their sunitinib-treated counterparts, with a significant HR for death or progression of 0.56.
Patients in the nivolumab plus cabozantinib group were more likely to achieve an objective response to treatment than those in the sunitinib group (56 vs 28%) and had a longer duration of response (median 23.1 vs 15.1 months), the researchers add.
The team notes that the nivolumab plus cabozantinib treatment arm also had a longer median duration of treatment than the sunitinib arm (21.8 vs 8.9 months) and that the safety profile “remained consistent with the primary analysis.”
Grade 3–4 treatment-related adverse events (TRAEs) occurred in 65% of patients given nivolumab plus cabozantinib and 54% of those given sunitinib, which the authors describe as being “a nominal respective increase from the primary analysis.” The most common TRAEs at this severity were hypertension (13 vs 12%), palmar–plantar erythrodysesthesia (8 vs 8%), and diarrhea (7 vs 5%).
“Overall, these data further support nivolumab plus cabozantinib as an efficacious first-line treatment option for advanced renal cell carcinoma among a broad range of patients,” Motzer et al conclude.
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