Lenvima Plus Keytruda ‘Stood the Test of Time’ for Kidney Cancer


Longer follow-up data showed that Lenvima plus Keytruda still outperformed Sutent in the treatment of patients with advanced renal cell carcinoma.

Lenvima (lenvatinib) plus Keytruda (pembrolizumab) improved outcomes compared with Sutent (sunitinib) for patients with advanced renal cell carcinoma, according to recent study findings, so patients “should feel very comfortable” if their clinicians choose the two-drug regimen for them, explained Dr. Thomas Hutson, a genitourinary oncologist at Texas Oncology-Baylor Charles A. Sammons Cancer Center, in an interview with CURE®.

Four-year follow-up data from the phase 3 CLEAR trial, which were presented at the 2023 ASCO Annual Meeting, showed that both overall survival (time from treatment until death of any cause) and progression-free survival (time from treatment until disease worsens) averages were longer in the Lenvima/Keytruda group compared with the Sutent group.

“This data has matured and it stood the test of time,” Huston said, noting that earlier data from the CLEAR trial led to the approval of frontline Lenvima plus Keytruda for this patient population in August 2021.

Specifically, at 48 months, 55.9% of patients were still alive in the Lenvima/Keytruda group, compared with 52.5% in the Sutent group. Additionally, median progression-free survival was 23.9 months and 9.2 months in the two-drug and single-agent groups, respectively. At 48 months, 24.5% in the Lenvima/Keytruda group did not experience disease progression, compared with 13.1% of patients in the Sutent group.

Additionally, a higher percentage of patients saw their disease shrink as a result of the two-drug therapy (71.3% compared with 36.7% of patients in the Lenvima/Keytruda groups, respectively), and fewer patients given Lenvima plus Keytruda had to move on to subsequent cancer therapies.

READ MORE: Lenvima-Keytruda Continues to Show Benefit in Advanced Kidney Cancer


The patient should feel very comfortable when their doctor is choosing (Lenvima plus Keytruda). This data has matured and it has stood the test of time. The great initial results that were published two years ago now, resolving the to regulatory approval, have been maintained and confirmed with efficacy benefits as predicted maintenance of an overall survival benefit. Benefits in progression-free survival, response rate, and comfortability that the side effects that they're experiencing are not cumulative. There's no additional safety signals for long-term use. So, at the end of the day, they should feel very comfortable with the choice that their physician has made for them.

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