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- 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.
- 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.
- Simcere Zaiming and
深圳市塔吉瑞生物医药有限公司
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.
