Updated follow-up of patients in the KEYNOTE-427 trial shows that first-line pembrolizumab monotherapy for advanced clear cell renal cell carcinoma (ccRCC) continues to show promising antitumor activity, investigators reported at the European Society for Medical Oncology 2019 Congress in Barcelona, Spain.

The analysis, which included 110 patients, revealed an overall objective response rate (ORR) of 36.4% after median 23 months of follow-up, according to James Larkin, FRCP, PhD, of The Royal Marsden NHS Foundation Trust in London, and collaborators.

The investigators observed meaningful responses across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups and regardless of PD-L1 status, according to a poster presentation. The ORR was 31.0% and 39.7% for patients with IMDC favorable-risk and intermediate- or poor-risk disease, respectively, and 44.2% and 29.3% for PD-L1 positive and negative patients, respectively.

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In addition, results showed that patients who experienced an 80% or greater reduction in target lesions had a durable overall survival (OS) benefit comparable to that of patients with confirmed complete response.

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Kaplan-Meier estimates showed that the overall population had a median progression-free survival of 7.1 months, according to the investigators. Median OS was not reached.


Larkin JMG, Tykodi SS, Donskov F, et al. First-line pembrolizumab (pembro) monotherapy in advanced clear cell renal cell carcinoma (ccRCC): Updated follow-up For KEYNOTE-427 Cohort A.   Presented at the European Society for Medical Oncology 2019 Congress held September 31 to October 1 in Barcelona, Spain. Poster 949P