Shots:
- Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
- At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs 10.7mos.), with favorable OS trend observed (mOS: 34.9 vs 27.6mos.). 2EPs showed cORR of 52.6% vs 39.6% at mFU of 19.6mos., while at 29mos. mFU, DoR was 23 vs 12.3mos.
- Based on LITESPARK-011, the FDA accepted sNDAs of Welireg & Lenvima for adults with clear cell advanced RCC following ti-PD-1/ PD-L1 therapy, with a PDUFA date of Oct 04, 2026, & global regulatory filings planned
Ref: Merck | Image: Merck | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
