Shots:
Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy
Trial showed significantly improved disease-free survival (1EP), with OS as 2EP under evaluation; data to be presented in future & shared…
Shots:
HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC
As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…
Shots:
China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy
NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
Shots:
The EMA’s CHMP has granted positive opinions and approvals to 5 Biologics and 2 New Chemical Entities in February 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Merck’s Welireg to treat Von Hippel-Lindau & Renal Cell Carcinoma
PharmaShots has compiled a list of 6 drugs…
Shots:
The P-III (CheckMate -9ER) trial assessed Cabometyx + Opdivo vs sunitinib in 651 pts with previously untreated advanced RCC
At 67.6mos. mFU, study showed improved mPFS (16.4 vs 8.3mos.), OS (46.5 vs 35.5mos.), ORR (55.7% vs 27.4%) & DOR (22 vs 15.2mos.), while in IMDC risk groups: favorable (n=146; mPFS: 21.4 vs 12.8mos.; mOS:…
Active Ingredient: Nivolumab
Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial
Dosage Form: Injection
Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1)
First Approval: US (22 Dec 2014), EU (19 Jun 2015)
Revenue Analysis of Opdivo
BMS’ Opdivo gives tough competition to other drugs in the…

