This update is based on data from KEYNOTE-B61, a Phase 2, single-arm trial evaluating KEYTRUDA (pembrolizumab),
While the label now includes efficacy data on the non-clear cell population, the approved indication for KEYTRUDA plus LENVIMA for the first-line treatment of adult patients with advanced RCC is unchanged.
KEYNOTE-B61 was a Phase 2, single-arm, multicenter trial that enrolled 160 patients with previously untreated nccRCC to investigate an immune checkpoint inhibitor in combination with a TKI. The major efficacy outcome measure was objective response rate (ORR) as assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Additional efficacy outcome measures included duration of response (DOR) as assessed by BICR using RECIST 1.1. The ORR was 51% (95% CI, 43-59), with a complete response rate of 8% and a partial response rate of 42%, for patients who received KEYTRUDA plus LENVIMA. The median DOR was 19.5 months (range: 1.5+, 23.5+ (+ denotes ongoing response)). No new safety signals were observed.
'Non-clear cell RCC is an aggressive, challenging-to-treat disease, and our goal is to address those unmet needs and advance care for these patients,' said Dr.
About KEYNOTE-B61
KEYNOTE-B61 is a multicenter, single-arm Phase 2 trial (ClinicalTrials.gov, NCT04704219) evaluating KEYTRUDA plus LENVIMA for the first-line treatment of adult patients with advanced/metastatic non-clear cell RCC that enrolled 160 patients.
Among the 160 patients, 158 patients received LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (400 mg every six weeks) for up to 24 months or until unacceptable toxicity or disease progression. LENVIMA could be continued as a single agent beyond 24 months until unacceptable toxicity or disease progression.
Among the 158 treated patients, the baseline characteristics were: median age of 60 years (range: 24 to 87 years); 71% male; 86% White, 8% Asian, and 3% Black;
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