Merck and Eisai Discontinue P-III Trial (LEAP-010) of Keytruda + Lenvima for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- The P-III trial (LEAP-010) evaluating Keytruda (200mg, IV, on Day 1 of each 3wk. cycle) + Lenvima (20mg, qd) vs Keytruda monotx. in a ratio (1:1) in 511 patients whose tumors express PD-L1
- IDMC conducted two planned interim analyses over 11mos. period where improvement in PFS and ORR were observed over Keytruda + PBO in 1st analysis but failed to improve OS as frontline therapy for patients with recurrent or metastatic HNSCC in 2nd analysis
- The safety profile was consistent with prior reported data while companies will work with investigators to share the results with the scientific community. Keytruda + Lenvima was approved in the US, the EU, Japan & other countries for advanced RCC & certain types of advanced EC
Ref: Merck | Image: Merck
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