Merck and Eisai to Present P-III Study (CLEAR) Results of Keytruda + Lenvima as 1L Treatment for Advanced Renal Cell Carcinoma at ASCO 2023
- The final pre-specified OS analysis results from the P-III CLEAR (Study 307)/(KEYNOTE-581) trial evaluating Keytruda (200mg, IV, q3w for ~24mos.) + Lenvima (20mg, qd) vs sunitinib in a ratio (1:1:1) in 1069 patients
- The results showed that the patients maintained a clinical OS benefit after 4yrs. of follow-up, 21% reduction in risk of death, 24 & 36mos. estimated OS rates (80.4% & 66.4%) for Keytruda + Lenvima vs (69.6% & 60.2%) for sunitinib
- The safety profile was consistent with the primary analysis, 53% reduction in risk of disease progression or death with an m-PFS (23.9 vs 9.2mos.); ORR (71.3% vs 36.7%), CR rate (18.3% vs 4.8%) with no new safety signals & grade ≥3 TRAE (74.1% vs 60.3%)
Ref: Businesswire | Image: Merck
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