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AnHeart Therapeutics Begins Phase II Basket Trial of Taletrectinib in NTRK-Positive Solid Tumors

NEW YORK – AnHeart Therapeutics said on Thursday it has begun a Phase II basket trial of its ROS1 and NTRK inhibitor taletrectinib in patients with NTRK fusion-positive solid tumors.

The single-arm trial will enroll up to 40 participants in China with locally advanced or systemic metastatic solid tumors with NTRK1/2/3 gene fusions. Patients need to have received previous treatment with either radiotherapy, chemotherapy, or targeted therapy. The primary endpoint for the study is best overall response.

In late 2019, AnHeart licensed taletrectinib from Daiichi Sankyo worldwide for an undisclosed amount. This month, AnHeart also entered into a $189 million exclusive license agreement with Innovent Biologics that gave Innovent rights to codevelop and commercialize AnHeart's taletrectinib in greater China including mainland China, Hong Kong, Macau, and Taiwan. AnHeart will continue developing taletrectinib up to regulatory approval in mainland China and supply taletrectinib for both developmental and commercial purposes in greater China.

AnHeart is also studying taletrectinib in the Phase II TRUST trial for patients with non-small cell lung cancer with ROS1 fusions, which began last year. In early data from that trial, 93 percent of participants, or 14 of 15 patients who had not received another ROS1 inhibitor, responded to taletrectinib.