Junshi Biosciences announces acceptance of sNDA for toripalimab combined with bevacizumab for advanced hepatocellular carcinoma
- The National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) for toripalimab combined with bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
- The sNDA is based on the HEPATORCH study, a phase III clinical trial that showed significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard treatment with sorafenib.
- The study involved 57 centers in China and demonstrated that the combination therapy significantly prolonged PFS and OS while improving secondary endpoints such as objective response rate and time to progression.
- No new safety signals were identified, and further details will be presented at a future international academic conference.
Read more
Biotheryx announces first patient dosed in phase 1 clinical trial of BTX-9341 for HR+/HER2- breast cancer
- Biotheryx has dosed the first patient in its Phase 1 trial of BTX-9341, a dual bifunctional degrader of CDK4/6.
- The trial will evaluate BTX-9341 as a monotherapy and in combination with fulvestrant for advanced HR+/HER2- breast cancer.
- The study will begin with dose escalation, followed by combination therapy, and conclude with dose expansion.
- Key assessments include safety, tolerability, pharmacokinetics, and pharmacodynamics, with a formal efficacy evaluation in an expansion cohort.
Read more
