ESMO 2021: Update From KEYNOTE-427 With Pembrolizumab Monotherapy for Kidney Cancer
Posted: Wednesday, October 6, 2021
The open-label, single-arm, phase II KEYNOTE-427 study previously found that first-line pembrolizumab monotherapy improved treatment outcomes and showed antitumor activity for patients with advanced clear cell renal cell carcinoma. Updated results from this study indicated that at 41 months of follow-up, this treatment appeared to remain safe and efficacious in this type of kidney cancer. This update was presented by David F. McDermott, MD, of Beth Israel Deaconess Medical Center, Boston, and colleagues during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 666P).
Patients enrolled in the KEYNOTE-427 study had advanced clear cell renal cell carcinoma with no prior exposure to systemic therapy (n = 110). These patients had received intravenous pembrolizumab monotherapy (200 mg every 3 weeks) until disease progression, toxicity, or withdrawal of consent.
The median duration of therapy was 8.5 months, with a median time from enrollment to data cutoff of 47.3 months. The overall response rate was found to be 36.4%, with a median duration of response of 18.9 months, and 43.5% of responding patients remained in response for 2 years or longer. A reduction in lesions was observed in 69% of patients, with nearly 20% of patients having a reduction of 80% or more in the sum of target lesions. The median progression-free survival was 7.1 months, and the median overall survival was 40.7 months.
When the study authors separated outcomes based on the International Metastatic Renal Cell Carcinoma Database (IMDC) risk scores, the overall response rate was found to be 31% for patients at favorable risk and 39.7% for those at intermediate or poor risk. The median progression-free survival for those at favorable risk was 9.7 months, and the median overall survival was not reached. For patients at intermediate or poor risk, the median progression-free survival and overall survival were 6.9 months and 30.8 months, respectively. There were no new safety signals identified.
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.