Phase 2 Trial Shows Antitumor Activity in Metastatic Clear Cell RCC

Chung-Han Lee, MD, PhD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the efficacy of a phase 2 study (NCT02501096) of pembrolizumab (Keytruda) and lenvatinib (Lenvima) in patient with metastatic clear cell renal cell carcinoma (ccRCC) who have progressed on an immune checkpoint inhibitor.

Lee says that in this setting, the trial was able to demonstrate a high objective response rate of 55% in patients by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) and 52% by RECIST version 1.1. For the patients who responded, the median duration of response was about 10 months, and most patients with metastatic ccRCC remained on treatment at the time of the data cutoff, which was April 9, 2020. Forty-six of the 91 patients with confirmed partial responses.

For the entire group of patients on this trial, there was a median progression-free survival of 11.7 months, and 45% of the total population remained progression-free at the 12-month time point, according to Lee. No new safety signals were observed in this trial, and the most common treatment-related adverse events were fatigue, diarrhea, and proteinuria.

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