On June 6, 2021 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, together with AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, reported a presentation of a scientific poster entitled "Preliminary results from TRUST: A phase II clinical study to investigate Taletrectinib in treating patients with ROS1 fusion positive non-small cell lung cancer (NSCLC)" which summarizes initial data from its ongoing trial of taletrectinib (NCT04395677) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Innovent Biologics, JUN 6, 2021, View Source [SID1234583621]).

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As of the data cut-off date of April 8, 2021, there were 15 crizotinib treatment-naïve patients and 5 crizotinib pre-treated patients, who had been confirmed to be ROS1 fusion positive and assessed at least twice by investigators. The results were as follows:

In the crizotinib treatment-naïve patients (n=15), the overall response rate (ORR) was 93% (14/15) and the disease control rate (DCR) was 93% (14/15);
In the crizotinib pre-treated patients (n=5), the ORR was 60% (3/5); and the DCR was 100% (5/5). ROS1 G2032R resistant mutations were identified in three of the five patients and all three patients experienced tumor regressions; and
Taletrectinib has shown a manageable safety profile characterized primarily by gastrointestinal adverse events, with reversible increases of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
"These safety and efficacy data for taletrectinib are very promising for ROS1 fusion positive lung cancer patients," 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, thus far all five patients continue to benefit from the drug."

"We are glad to see the study result of Taletrectinib can be presented at ASCO (Free ASCO Whitepaper) meeting, the most authoritative clinical oncology conference", said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, "In China, ROS1 positive fusion patients have limited treatment choices at present. More new drugs are needed to develop for clinical application. Taletrectinib has shown good efficacy and safety results, which offers hope to patients with ROS1 fusion positive non-small cell lung cancer."

"Our team is highly focused on completing patient enrollment for this phase II TRUST trial in Q3 2021," said Bing Yan, MD, co-founder and chief medical officer of AnHeart. "These data from the TRUST trial have built a solid foundation for our upcoming global trials of taletrectinib and will support us in seeking regulatory approvals of talectrectinib in China and globally. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to bringing taletrectinib to all ROS1 fusion positive patients in the near future upon approval."

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

On 1 June 2021, Innovent and Anheart announced an exclusive license agreement for the co-development and commercialization of AnHeart’s lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK – in Greater China, including mainland China, Hong Kong, Macau and Taiwan.