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Pembrolizumab (Keytruda) continues to delay disease recurrence in patients with surgically removed early-stage non-small cell lung cancer (NSCLC), according to the final analysis of the KEYNOTE-091 trial. After nearly 7.5 years of follow-up, patients on pembrolizumab had a median disease-free survival of 58.7 months vs. 43.3 months on placebo. However, overall survival remained similar between the two groups.
The final results of the phase 3 PEARLS/KEYNOTE-091 trial confirm that adjuvant pembrolizumab continues to keep early-stage lung cancer at bay longer than placebo — but hasn't yet translated that benefit into a survival advantage. Presented at the 2026 ESMO Congress, the trial followed 1,177 patients with completely resected stage IB to IIIA NSCLC for a median of nearly 7.5 years.
Patients on pembrolizumab saw a median disease-free survival (DFS) of 58.7 months compared to 43.3 months for those on placebo. Overall survival, however, was statistically similar between the two arms — a finding partly complicated by the fact that nearly 30% of placebo patients who progressed later received immunotherapy, potentially narrowing any survival gap.
By the Numbers:
Why it matters: These long-term data reinforce pembrolizumab's role as an FDA-approved adjuvant therapy for resected NSCLC, offering patients a meaningful delay in recurrence. The lack of OS benefit remains an open question, but researchers note the final OS analysis was time-triggered before the planned number of deaths occurred.
