On December 9, 2024 TransThera Sciences Nanjing, Inc. (the "TransThera") reported the poster presentation at the 2024 European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress to discuss the clinical study of tinengotinib in combination with atezolizumab (Tecentriq) in biliary tract carcinoma (BTC) (Press release, TransThera Biosciences, DEC 9, 2024, View Source [SID1234648937]).

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Title: Tinengotinib (TT-00420) in Combination with Atezolizumab in Chinese Patients with Biliary Tract Carcinoma (BTC): Efficacy and Safety Results from a Phase Ib/II Study

Poster number: 140P

Immune-checkpoint inhibitor (ICI) combined with chemotherapy have been approved as first-line therapy for BTC. However, no standard of care has been established after first-line treatment and the survival of the patients is short, there is a huge unmet clinical need. Tinengotinib is a novel multi-kinase inhibitor. It may play a role of synergistic effect when combined with ICI. The efficacy and safety data of tinengotinib in combination with atezolizumab in Chinese BTC patients has been explored in a phase Ib/II study.

Results:

As of September 26, 2024, a total of 31 heavily pretreated advanced BTC patients were enrolled and treated with tinengotinib plus atezolizumab. 71.0% were priorly treated with at least one immunotherapy.

Promising efficacy:

A total of 20 intrahepatic cholangiocarcinoma patients were efficacy evaluable. The objective response rate (ORR) and disease control rate (DCR) were 25.0% and 80.0%, the median progression free survival (mPFS) reached 8.77 months and the 12-month overall survival (OS) rate was 70.1%.
A total of 28 cholangiocarcinoma patients were efficacy evaluable. The ORR and DCR were 25.0% and 75.0%, the mPFS reached 5.72 months and the 12-month OS rate was 64.8%.
All 31 BTC patients were efficacy evaluable. The ORR and DCR were 22.6% and 74.2%, the mPFS reached 4.11 months and the 12-month OS rate was 61.8%.
Similar efficacy was observed regardless of prior ICI(s) therapy.
Good safety and tolerability:

No DLT was observed in the dose escalation phase.
The combination therapy was generally well tolerated in heavily pre-treated BTC patients.
These encouraging results suggest the combination therapy may have synergistic effect in treating some solid tumor such as BTC, and support the further exploration to evaluate the safety and efficacy of tinengotinib plus ICI in BTC patients who were previously treated with or without ICI therapy.

About Tinengotinib

Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by EMA.