Recent Articles in Trials & Approvals

Yantai RemeGen said an interim analysis of its anti-HER2 antibody drug conjugate (ADC) showed efficacy in the cervical cancer cohort of a China Phase II trial. The Phase II open-label trial is currently testing Disitamab Vedotin (RC48) as a monotherapy in patients with HER2-expressing gynecologic malignancies. In June 2021, RC48 was granted conditional approval in China for locally advanced or metastatic gastric cancer. Three years ago, RemeGen out-licensed ex-China rights for RC48 to Seattle’s Seagen in a $2.6 billion ($200 million upfront) agreement. More details....

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Beijing’s Akeso (HK: 9926) enrolled the first patient in a Phase III clinical trial of cadonilimab (a PD-1/CTLA-4 bispecific antibody) as a first-line treatment for patients with PD-L1 negative non-small cell lung cancer. Cadonilimab will be combined with chemotherapy and compared to tislelizumab (a PD-1 antibody) combined with chemotherapy. Cadonilimab, which is being tested in more than 60 ongoing clinical studies, is already approved as a second/third line therapy for advanced cervical cancer, and it has completed a successful Phase III trial as a first-line gastric cancer therapy. More details....

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Nanjing TransThera was approved to begin a European Phase III trial of tinengotinib in patients with cholangiocarcinoma (CCA). CCA, a cancer in the tubes that carry the digestive fluid bile through the liver, is a rare but aggressive form of cancer. To be enrolled, patients must have FGFR-altered disease that is refractory/relapsed from chemotherapy or a FGFR Inhibitor. The European Phase III trial is part of a global study of the drug. Tinengotinib, a next-gen FGFR inhibitor, has shown potency against a variety of FGFR2 kinase domain mutations in Phase I and II trials for the CCA indication. More details....

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Suzhou Innovent and AnHeart Therapeutics of Hangzhou have filed a second NDA of their partnered next-gen ROS1 TKI in China. The new NDA, which has been accepted for review by China’s CDE, is for use of taletrectinib as a first-line therapy for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have not previously been treated with a ROS1 TKI. The first NDA filing was for NSCLC patients who have been previously treated with ROS1 TKIs. In 2021, Innovent entered a $189 million agreement with AnHeart to commercialize taletrectinib in Greater China. More details....

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Jinan Qilu Pharma presented data from a Phase II trial showing that its QL1706 combination therapy of a PD-1 and CTLA-4 was effective against cervical cancer. The combination met its primary endpoint with an objective response rate of 33.8%. In August 2023, China’s NMPA accepted a new drug application for QL1706, the first MabPair product targeting PD-1 and CTLA-4 worldwide. Qilu will present the trial data at The European Society of Gynecological Oncology (ESGO) 2024 Conference later this week. More details....

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