TransThera Highlights Promising Phase Ib/II Results for Tinengotinib in Nature Communications

Bulletin Express
05/17

TransThera Sciences (Nanjing) reported new Phase Ib/II data showing that its spectrum-selective multi-kinase inhibitor tinengotinib delivered notable antitumor activity both as a standalone therapy and in combination with the immune checkpoint inhibitor atezolizumab in patients with advanced solid tumors.

The China-based study (NCT05253053) evaluated two treatment arms: • Arm A – tinengotinib monotherapy in 53 patients with advanced solid tumors recorded an objective response rate (ORR) of 16.70%. • Arm B – tinengotinib plus atezolizumab in 31 patients with advanced biliary tract cancer posted an ORR of 22.60%.

Subgroup analyses underscored particularly strong signals in cholangiocarcinoma: • Monotherapy: ORR of 30.80% in 13 cholangiocarcinoma patients; a higher ORR of 66.70% was achieved in those harboring FGFR2 fusions who had progressed on prior FGFR inhibitors. • Combination therapy: ORR of 25.00% in 28 cholangiocarcinoma patients, with a disease control rate of 75.00% in the 20 patients previously treated with immune checkpoint inhibitors.

The findings, published in the peer-reviewed journal Nature Communications (Impact Factor = 15.7), support further clinical development of tinengotinib as both monotherapy and in combination regimens. The company cautioned, in line with Rule 18A.08(3) of the Hong Kong Listing Rules, that there is no assurance the drug will ultimately achieve successful commercialization.

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