On September 27, 2021 AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, together with Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that interim clinical data from a Phase Ⅱ trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC) (Press release, AnHeart Therapeutics, SEP 27, 2021, View Source [SID1234590324]). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021.

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The scientific presentation entitled: "Taletrectinib (AB-106): Preliminary results from TRUST, Phase Ⅱ trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC)," summarized preliminary data from an ongoing Phase Ⅱ trial of taletrectinib (NCT04395677).

As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows:

In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21).
In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16).
Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD).
In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6).
Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.
"We are pleased with the interim Phase Ⅱ data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer," said Dr. Caicun Zhou, Director of the Department of Oncology, Shanghai Pulmonary Hospital. "Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug."

"Our team is focused on completing patient enrollment for our Phase Ⅱ TRUST trial," said Bing Yan, MD, Co-founder and Chief Medical Officer at AnHeart Therapeutics. "The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs."

"We are glad to see the interim Phase Ⅱ data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China," said Dr. Hui Zhou, Senior Vice President of Innovent, "In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC."

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source