European Commission approves Merck’s Keytruda plus Padcev for first-line treatment of urothelial carcinoma
- The European Commission (EC) has approved Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
- This approval is based on the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy.
- The combination therapy reduced the risk of death by 53% and the risk of disease progression or death by 55% versus platinum-based chemotherapy.
- This approval allows marketing of the combination therapy in all 27 EU member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
Read more
HighField Biopharmaceuticals files IND in China for clinical trial of HF50 to treat solid tumor cancers
- HighField Biopharmaceuticals has filed an IND application with China’s National Medical Products Administration for HF50.
- HF50 is a unique lipid-based T cell engager designed to treat solid tumors by directing T cells to attack cancer cells.
- The drug uses a TRAFsome structure, combining two antibodies and a payload of Resiquimod to enhance anti-tumor activity.
- Preclinical studies show HF50 is effective in both in vitro and in vivo, with significant efficacy in humanized tumor-bearing mice models.
Read more
Simcere Zaiming collaborates with TargetRx to introduce third-generation ALK inhibitor
- Simcere Zaiming and Shenzhen TargetRx Inc. have entered a collaboration for the ALK/ROS1 inhibitor TGRX-326.
- Simcere Zaiming will acquire exclusive commercial rights for TGRX-326 in mainland China, including marketing and strategy formulation.
- TargetRx will receive an initial payment of over $20 million and will compensate Simcere Zaiming for promotional services.
- TGRX-326 has shown strong anti-tumor activity and a favorable safety profile in preclinical and Phase 1 clinical trials, particularly for ALK/ROS1-positive non-small cell lung cancer (NSCLC) patients with brain metastases.
Read more
