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Nivolumab, ipilimumab combination shows promise for renal cell carcinoma
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Combination therapy with nivolumab and ipilimumab led to notable antitumor activity and durable response among patients with metastatic renal cell carcinoma, according to safety and efficacy results of the CheckMate 016 clinical trial.
“For this group of patients, these are very significant results,” Hans J. Hammers, MD, PhD, associate professor of internal medicine at UT Southwestern, and co-leader of the kidney cancer program at The Harold C. Simmons Compressive Cancer Center, said in a press release.
Previous data showed a combination of nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 inhibitor, and ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, produced greater durable response than either agent alone in patients with metastatic melanoma and lung cancer, suggesting an added benefit for various tumor types.
In CheckMate 016, researchers evaluated the combination of nivolumab and ipilimumab or nivolumab plus a tyrosine kinase inhibitor in patients with metastatic renal cell carcinoma.
In the current analysis, researchers evaluated data from 100 patients randomly assigned to three different dosing combinations of nivolumab plus ipilimumab received — 3 mg/kg IV nivolumab plus 1 mg/kg ipilimumab (N3I1; n = 47), 1 mg/kg nivolumab plus 3 mg/kg ipilimumab (N1I3; n = 47), or 3 mg/kg nivolumab plus 3 mg/kg ipilimumab (N3I3; n = 6). Following combination therapy every 3 weeks for four doses, patients received 3 mg/kg nivolumab monotherapy biweekly until progression or toxicity.
At the time of analysis, researchers suppressed data from all six patients in the N3I3 group due to dose-limiting toxicity or other reasons. Therefore, results reported include only the N3I1 and N1I3 groups.
Baseline clinical characteristics appeared similar between the groups.
At a median follow-up of 22.3 months, 97.9% of patients in the N3I1 group and 89.4% in the N1I3 group received at least 90% of the planned dose intensity during the induction phase.
The objective response rate was 40.4% in both arms, with ongoing responses in 42.1% of patients in the N3I1 group and 36.8% of patients in the N1I3 group.
Two-year OS rate was 67.3% in the N3I1 group and 69.6% in the N1I3 group.
All patients in both groups experienced an adverse event of any grade, and 71.3% experienced a grade 3 to 4 event.
Treatment-related adverse events occurred in 93.6% of all patients. Grade 3 to grade 4 treatment-related adverse events occurred in 38.3% of patients in the N3I1 group compared with 61.7% in the N1I3 group.
The N3I1 group most frequently experienced increased lipase (n = 7), as well as diarrhea, pyrexia, increased aspartate transaminase, increased alanine transaminase and increased amylase (n = 2 each). The N313 group most frequently experienced increased lipase (n = 13), increased alanine transaminase (n = 10), diarrhea (n = 7), colitis (n = 7) and increased aspartate transaminase (n = 6).
“While side effects of immunotherapy can be significant, they are typically reversible, and unlike current therapies, don’t significantly dampen patients’ daily quality of life,” Hammers said.
A phase 3 clinical trial further investigating the combination has completed enrollment, according to the press release.
If phase 3 results indicate similar responses, the combination regimen could serve as a new standard of care for patients with renal cell carcinoma, Hammers said. – by Melinda Stevens
Disclosure: Hammers reports he is a consultant or advisor with Bayer, Bristol-Myers Squib, Cerulean, Exelixis and Pfizer; receives research funding to his institution from Bristol-Myers Squibb; and receives research funding from Exelixis, GlaxoSmithKline, Newlink, Pfizer, SFI and Tacon. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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