renal cell carcinoma

Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients with Advanced Clear Cell Renal Cell Carcinoma

Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients with Advanced Clear Cell Renal Cell Carcinoma

In the March 20, 2021 edition of Journal of Clinical Oncology, David F. McDermott and colleagues report on the results of pembrolizumab monotherapy as first line treatment in advanced renal cell carcinoma.

PURPOSE

KEYNOTE-427 study is a phase 2 clinical trial where the efficacy and safety of pembrolizumab monotherapy in untreated patients with advanced clear cell renal cell carcinoma (cohort A) and advanced non-clear cell RCC (cohort B)

METHODS

The study was an open label, single-arm phase II study in patients with advanced clear cell RCC who were treated with pembrolizumab 200 mg every 3 weeks for up to 2 years with a primary end point of ORR per RECIST, version 1.1.

RESULTS

110 patients were reviewed. The ORR was 36.4% with 4 (3.6%) CRs and 36 (32.7%) PRs; CBR was 58.2% (95% CI, 48.4 – 67.5). 68.2% of patients had a decrease in target lesions, including 30.9% with a reduction ≥ 60%. The median duration of response was 18.9 (range, 2.3 to 37.6+ months) months; 64.1% of responders had a response that lasted for more than 1 year. The median PFS was 7.1 months (95% CI, 5.6 to 11.0). The median OS was not reached; 1 year and 2-year overall survival rates were 88.2% and 70.8%, respectively. Durable responses were noted across all International Metastatic RCC Database Consortium categories.  Colitis and diarrhea were the most common grade 3-5 treatment-related adverse events, seen in 30.0% of patients.

The authors concluded “Single-agent pembrolizumab showed promising antitumor activity as a first-line treatment in patients with advanced ccRCC, with durable responses across International Metastatic RCC Database Consortium categories. Safety and tolerability profile of pembrolizumab monotherapy was comparable to what has been previously described in other tumor types.”

https://ascopubs.org/doi/full/10.1200/JCO.20.02363

en_USEnglish