Eisai will present kidney cancer trial analyses at the Oct. 25 European Society for Medical Oncology (ESMO) Congress, covering a U.S.-approved regimen and experimental treatments that missed interim survival criteria.
The congress runs Oct. 23-27 in Madrid. Eisai lists the final LITESPARK-011 analysis and LITESPARK-012 findings in a 3:30-5 a.m. ET session on Oct. 25 (07:30-09:00 UTC). A separate LITESPARK-011 session on health-related quality of life and efficacy is scheduled for later that day.
The U.S. Food and Drug Administration (FDA) approved belzutifan (WELIREG) with lenvatinib (LENVIMA) on Sept. 24 for adults with advanced renal cell carcinoma with a clear cell component after treatment with a PD-1 or PD-L1 inhibitor. The agency’s review covered 747 LITESPARK-011 participants. FDA figures show median progression-free survival of 14.6 months with the combination, compared with 10.6 months with cabozantinib. Median overall survival was 33.7 months and 28.6 months, respectively, but the FDA said the final analysis did not establish a statistically significant overall-survival result.
The studies address different stages of treatment: LITESPARK-011 follows prior immunotherapy, while LITESPARK-012 evaluates initial therapy. LITESPARK-012 enrolled 1,688 patients and compared pembrolizumab, lenvatinib and belzutifan together, or MK-1308A with lenvatinib, against pembrolizumab plus lenvatinib. Merck and Eisai said in April that interim results for the experimental groups did not establish the required benefit on progression-free or overall survival.
Eisai’s wider ESMO program includes an exploratory biomarker analysis from LEAP-001 and a survey of U.S. patients’ endometrial cancer experiences. The company also lists long-term overall-survival findings from liver cancer study LEAP-012 and end-of-trial safety findings from head and neck cancer study LEAP-009. Its Oct. 15 schedule release does not provide results from the upcoming kidney cancer analyses.
Eisai set the online release of regular abstracts for 6:05 p.m. ET on Oct. 18 (22:05 UTC).
