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Nivolumab-ipilimumab combination improves response rate in renal cell carcinoma
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A phase 3 trial designed to compare nivolumab plus ipilimumab with sunitinib monotherapy for first-line treatment of intermediate- or poor-risk patients with renal cell carcinoma met its coprimary endpoint of objective response rate.
Results showed a trend toward improved PFS — the trial’s other coprimary endpoint — with the combination, but the difference did not reach statistical significance.
The randomized, phase 3 CheckMate -214 trial included patients with previously untreated advanced or metastatic renal cell carcinoma.
Researchers assigned patients to one of two regimens: combination therapy with the PD-1 immune checkpoint inhibitor nivolumab (Opdivo, Bristol-Myers Squibb) and the CTLA-4 inhibitor ipilimumab (Yervoy, Bristol-Myers Squibb), or monotherapy with sunitinib (Sutent, Pfizer), a multikinase inhibitor.
Patients assigned the combination received 3 mg/kg nivolumab plus 1 mg/kg ipilimumab every 3 weeks for four doses, followed by 3 mg/kg nivolumab every 2 weeks.
Patients assigned sunitinib monotherapy received 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment.
Treatment in both groups continued until progression or unacceptable toxicity.
PFS, OS and objective response rate served as coprimary endpoints. Safety served as a secondary endpoint.
Researchers reported a higher ORR among patients assigned the combination regimen (41.6% vs. 26.5%).
Patients assigned the combination also achieved longer median duration of response (not reached vs. 18.17 months) and longer median PFS (11.56 months vs. 8.38 months; HR = 0.82; 95% CI, 0.64-1.05).
The combination’s tolerability profile appeared consistent with that observed in prior studies that used the same dosing schedule.
The study will continue, and OS data will be reported when they are mature.
“We are encouraged by the totality of the CheckMate -214 data,” Vicki Goodman, MD, development lead of melanoma and genitourinary cancers at Bristol-Myers Squibb, said in a company-issued press release. “The ORR and duration of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate- and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. This is an important study in first-line renal cancer as these patients need new options.”