Opdivo (nivolumab), when given with or without Yervoy (ipilimumab) improved outcomes for patients with intermediate-risk and poor-risk clear-cell metastatic renal cell carcinoma (a type of kidney cancer) who did not respond or stopped responding to upfront Opdivo, according to clinical trial findings that were recently published in the journal, The Lancet Oncology.
The phase 2 TITAN-RCC trial, which was conducted in cancer treatment centers in Austria, Belgium, Czechia, France, Germany, Italy, Spain and the United Kingdom, included 207 patients who were previously untreated or had undergone one prior anti-angiogenic or chemotherapy regimen. Once enrolled in the study, patients were prescribed intravenous Opdivo once every two weeks.
Patients whose disease responded to Opdivo continued with therapy. If they experienced early progressive disease at or by week eight or if their cancer did not respond (shrink or disappear) by week 16, they then were administered two or four doses of Opdivo and Yervoy boosts.
The main goal of the study was to see if the objective response rate (percentage of patients whose disease shrinks or disappears from treatment) would improve by 25% or more compared to those seen in the phase 3 CheckMate-025 trial, which led to the 2015 approval of Opdivo for metastatic renal cell carcinoma that was previously treated with an anti-angiogenic therapy.
Researchers also analyzed remission rates, time to response, duration of response, progression-free survival (time from treatment until death or disease worsening), time to immunotherapy resistance and overall survival (time from treatment until death of any cause).
Findings showed that at a median follow-up of 27.6 months, 39 of 109 (36%) previously untreated patients and 31 of 98 (32%) in the previously treated groups had a confirmed objective response with Opdivo with and without Opdivo plus Yervoy. Confirmed reponse to Opdivo at week eight or 16 was 28% and 18% in the previously untreated and previously treated groups, respectively.
The most frequently moderate to severe (grade 3 or 4) side effects that were reported in 5% or more of patients on the study were: increased lipase, which could indicate pancreatic issues (7% of patients), colitis (6%) and diarrhea (6%). Three deaths occurred in the trial, which researchers deemed to be related to the treatment: one due to possible ischemic stroke, one due to respiratory failure and one due to pneumonia, according to the findings.
Since Opdivo and Yervoy work by igniting the immune system to find and fight cancer cells, side effects from these type of agents are often treated with corticosteroids, which are a class of drugs that work by reducing inflammation and suppressing the immune system.
“In treatment-naïve patients, (Opdivo) induction with or without (Opdivo) plus (Yervoy) boosts significantly improve the objective response rate compared with that reported for (Opdivo) monotherapy in the CheckMate-025 trial,” the researchers wrote. “However, overall efficacy seemed inferior when compared with approved upfront (Opdivo) plus (Yervoy). For second-line treatment, (Opdivo) plus (Yervoy) could be a rescue strategy on progression with approved (Opdivo) monotherapy.”
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