Merck and Eisai Discontinue P-III Trial (LEAP-010) of Keytruda + Lenvima for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Shots:
- 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
Related News:- Merck Reports P-III Trial (LITESPARK-005) Results of Welireg (belzutifan) for Patients with Advanced Renal Cell Carcinoma
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
