(Renal Cancer) Keytruda + Lenvatinib Effective?

On July 14, 2023, Laurence Albiges et al. from Paris-Saclay University published in the medical journal The Lancet the efficacy and safety results of Keytruda (pembrolizumab) plus lenvatinib as first-line treatment for patients with non-clear cell advanced renal cell carcinoma in the KEYNOTE-B61 Phase II clinical trial.

The KEYNOTE-B61 Phase II trial treated patients with non-clear cell advanced renal cell carcinoma with Keytruda (400 mg every six weeks) plus lenvatinib (20 mg once daily) as first-line therapy until disease progression or intolerable adverse events. The primary endpoint was objective response rate (ORR).

Among the 158 trial participants, the median age was 60 years (range 52–69). Gender: 71% male (N=112) and 29% female (N=46). Race: 81% White (N=128), 8% Asian (N=12), 2% Black or African American (N=3).

At a median follow-up of 14.9 months, the primary endpoint ORR was 49%, including complete response in 6% (N=9) and partial response in 44% (N=69).

Regarding safety, Grade 3–4 adverse events occurred in 51% of patients (N=81/158). The most common adverse events included hypertension (23%), proteinuria (4%), and stomatitis (4%). Serious adverse events occurred in 20% (N=31/158), and adverse event-related deaths occurred in 5% (N=8).

Based on KEYNOTE-B61 results, Laurence Albiges et al. concluded: First-line treatment with Keytruda plus lenvatinib in patients with non-clear cell advanced renal cell carcinoma demonstrated durable anti-tumor activity and has the potential to become a first-line treatment option for this patient population.

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00276-0/fulltext

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