Lenvima Plus Keytruda May Become Next Standard-of-Care Treatment Option for Advanced Kidney Cancer

Treatment with Lenvima plus Keytruda resulted in a 50% decrease in risk of disease progression or death compared with Sutent in patients with advanced kidney cancer.

The drug duo of Lenvima (lenvatinib) plus Keytruda (pembrolizumab) tended to lead to better outcomes (a 50% reduction in the risk of disease progression or death) than Sutent (sunitinib) for patients with advanced kidney cancer, even after accounting for later therapies, according to findings from the phase 3 CLEAR clinical trial.

The study authors analyzed next-line progression-free survival (time from treatment until disease worsens) in 355 patients who received the Lenvima/Keytruda combination, and 357 patients prescribed Sutent.

To be eligible for the trial, patients had to have a confirmed renal cell carcinoma with clear-cell components and documented evidence of advanced disease. Patients could not have undergone prior systemic therapy, have one or more measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and a Karnofsky performance score of 70 or higher.

Of note, RECIST is a set of rules that providers use to determine a disease’s response to therapy. Moreover, a Karnofsky performance score is used to identify a patient’s functional capabilities. A score of 70 or higher indicates a person is capable of caring for themselves at various levels.

Since so many patients in the Lenvima plus Keytruda group were still alive at the time of data collection, the average second-line progression-free survival was not met. Meanwhile, it was 28.7 months in the Sutent group.

“These findings remained consistent after accounting for subsequent therapies, as evidenced by (second-line progression-free survival) and adjusted (overall survival),” the researchers wrote in an abstract of the data which were presented at the 2022 American Society of Clinical Oncology Annual Meeting.

At the 24-month mark, 72.7% of patients in the combination therapy group were alive on their second line of treatment, compared to 54.2% in the Sutent group. Revlimid plus Keytruda also outperformed Sutent at the 36-month mark, with second-line progression-free survival rates of 61.9% and 42.9%, respectively.

In all, 117 patients in the Lenvima/Keytruda group and 206 patients on the Sutent group went on to another line of therapy. The average time until the next treatment was 12.2 months for those given Lenvima and Keytruda, and 6.4 months for those given Sutent.

The most common next-line of therapy was anti-VEGF treatment, (30.4% of patients in the Lenvima/Keytruda cohort and 33.6% in the sunitinib group), followed by checkpoint inhibition (8.2% and 43.1%, respectively), MTOR inhibition (1.7% and 4.8%) CTLA-4 inhibition (1.7% and 5%) and other (3.4% and 5.6%).

Lenvima plus Keytruda also improved second-line progression-free survival in favorable-, intermediate- and poor-risk groups compared to Sutent.

The average duration of first subsequent treatment was 5.2 months for the Lenvima/Keytruda group, and 6.8 months in the Sutent group.

“These results further support the use of (Lenvima) plus (Keytruda) as a standard-of-care first-line treatments for patients with (advanced) RCC,” the authors concluded.

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Editor's note: A previous version of this article stated that the combination treatment consisted of Revlimid and Keytruda. It in fact was Lenvima and Keytruda.