Survival Benefit With Lenvima/Keytruda for Advanced Clear Cell RCC Continues After 4 Years

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After a median follow-up of four years, the survival benefit, including progression-free survival persisted in patients with advanced clear cell renal cell carcinoma treated with Lenvima plus Keytruda compared with those treated with Sutent.

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At a median follow-up of approximately 50 months, treatment with Lenvima plus Keytruda led to a 21% reduction in the risk of death compared with Sutent.

Survival benefits from treatment with Lenvima (lenvatinib) and Keytruda (pembrolizumab) were sustained compared with Sutent in pateints with advanced clear cell renal cell carcinoma (RCC) after four years of follow-up, according to updated study results.

These findings from the phase 3 CLEAR study were presented at the 2023 ASCO Annual Meeting.

At a median follow-up of approximately 50 months, treatment with Lenvima plus Keytruda led to a 21% reduction in the risk of death compared with Sutent. The median overall survival (the time when a patient with cancer is still alive) was 53.7 months with the combination versus 54.3 months with Sutent. The overall survival rates at 24, 36, and 48 months all favored the combination arm versus the control arm at 80.4% versus 69.6%, 66.4% versus 60.2%, and 55.9% versus 52.5%, respectively.

When presenting these data at the ASCO meeting, study author Thomas E. Hutson explained that the reason the overall survival outcomes for the two study arms appeared to come closer together at the four-year time point was due to subsequent anticancer medications.

“Sixty-nine percent of patients who received (Sutent) went on to receive subsequent anticancer therapy, including anti-VEGF therapy in 45% and PD-1/L1 checkpoint inhibitors in 55%. This is comparted to only 51% of patients moving on to additional anticancer therapy in the (Lenvima)/(Keytruda) group, with only 16% receiving PD-1/L1 checkpoint inhibitors,” said Hutson, who is director of the urologic oncology program and co-chair of the Urologic Cancer Research and Treatment Center at Baylor University Medical Center.

Hutson said the investigators adjusted data in the study to account for the potential impact of subsequent anticancer medications, which suggested “that the (overall survival) analysis was indeed impacted by the imbalance in the use of subsequent anticancer medication in the (Sutent) group versus the (Lenvima)/(Keytruda) group.”

Regarding progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening), Hutson said that with an additional 23 months of follow-up, the median progression-free survival was 23.9 months with Lenvima plus Keytruda compared with 9.2 months with Sutent, translating to a 53% reduction in the risk of disease progression or death. The progression-free survival rates at 24, 36, and 48 months all favored the Lenvima/Keytruda versus the Sutent group at 49% versus 23.4%, 37.3% versus 17.6%, and 24.5% versus 13.1%, respectively.

Overall, the three-arm CLEAR study randomized patients to receive Lenvima plus Keytruda (355 patients), Lenvima plus everolimus (357 patients) or oral Sutent (357 patients). Updated findings for the everolimus arm were not presented at the ASCO meeting.

Baseline characteristics showed that the median patient age was 64 years in the combination arm and 61 years in the Sutent arm. In the combination arm, 27% of patients had favorable risk, 64% had intermediate and 9% had poor risk disease.

The objective response rate (the percentage of patients with a partial or complete response to treatment) was 71.3% with Lenvima plus Keytruda compared with 36.7% for Sutent. The rate of complete responses (the disappearance of all signs of cancer as a result of treatment) was 18.3% with the combination compared with 4.8% for Sutent. The median duration of response (the time from when a response to treatment was observed to progression or all-cause death, whichever occurred first) was 26.7 months with Lenvima/Keytruda compared with 14.7 months with Sutent.

Regarding safety, Hutson said, “No new safety signals were identified; adverse events were managed with dose modifications as necessary.”

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