Lenvima + Keytruda demonstrateslong-term, durable survival benefit versus sunitinib as first-line treatment for advanced renal cell carcinoma
Eisai and Merck & Co., Inc., announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase III CLEAR (Study 307)/KEYNOTE-581 trial investigating Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, Merck’s anti-PD-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
These data will be presented on Monday, June 5 at 11:54 a.m. Central Daylight Time during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502).
After four years of follow-up, Lenvima plus Keytruda maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for Lenvima plus Keytruda versus 69.6% and 60.2% for sunitinib, respectively. Results from the final prespecified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial. Additionally, Lenvima plus Keytruda reduced the risk of disease progression or death by 53% (HR=0.47 [95% CI, 0.38-0.57]), with a median progression-free survival (PFS) of 23.9 months (95% CI, 20.8-27.7) for Lenvima plus Keytruda versus 9.2 months (95% CI, 6.0-11.0) for sunitinib; the objective response rate (ORR) was 71.3% (95% CI, 66.6-76.0) with a complete response (CR) rate of 18.3% for Lenvima plus Keytruda versus an ORR of 36.7% (95% CI, 31.7-41.7) with a CR rate of 4.8% for sunitinib.
There were no new safety signals and the safety profile at the final OS analysis was consistent with the primary analysis. Grade greater than 3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received Lenvima plus Keytruda versus 60.3% of patients who received sunitinib. The six most common TRAEs of any grade of patients in the Lenvima plus Keytruda arm were diarrhea (56.0%), hypertension (54.3%), hypothyroidism (44.9%), decreased appetite (35.5%), fatigue (34.1%) and stomatitis (32.7%). In the sunitinib arm, the six most common TRAEs of any grade were diarrhea (45.3%), hypertension (40.3%), stomatitis (37.4%), palmar-plantar erythrodysesthesia (36.2%), fatigue (32.9%) and nausea (28.2%).
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