Significant improvement seen in overall survival with pembrolizumab versus placebo and across key subgroups
For patients with clear-cell renal cell carcinoma (ccRCC), overall survival (OS) is improved for those receiving pembrolizumab versus placebo at a median follow-up of about 57 months, according to a study presented at the American Society of Clinical Oncology annual Genitourinary Cancers Symposium, held from Jan. 25 to 27 in San Francisco.
Toni Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues randomly allocated 994 adults with histologically confirmed ccRCC to receive pembrolizumab 200 mg or placebo intravenously every three weeks for ≥17 cycles (about one year) or until disease recurrence, intolerable toxicity, or withdrawal of consent (496 and 498 patients, respectively). The primary end point was disease-free survival (DFS) by investigator assessment; OS was a key secondary end point. Results from the third prespecified interim analysis with a median follow-up of about 57 months were reported.
The researchers found that OS improved significantly with pembrolizumab versus placebo (medians not reached; hazard ratio, 0.62). There were 55 and 86 OS events in the pembrolizumab and placebo arms, respectively. At 48 months, the estimated OS rate was 91.2 and 86.0 percent with pembrolizumab and placebo, respectively. Across key subgroups, there was an OS benefit observed, including in patients with M0 disease (hazard ratio, 0.63). For pembrolizumab versus placebo, the observed DFS was consistent with that of prior interim analyses (hazard ratio, 0.72). There were no new safety signals.
“We can now tell our patients that pembrolizumab after surgery not only delays recurrences but also helps them live longer,” Choueiri said in a statement.
Several authors disclosed ties to pharmaceutical companies, including Merck, which manufactures pembrolizumab and funded the study.
