AnHeart and Innovent Releases Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting
June 9, 2021
Hangzhou, China June 7/New York June 6, 2021 – AnHeart Therapeutics Co., Ltd (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, together with Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), today jointly announce 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) 2021 Annual Meeting. 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.”
“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.”
“We are glad to see that the study results of taletrectinib can be presented at the ASCO 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 in development 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.”
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 https://clinicaltrials.gov.
AnHeart Therapeutics Co., Ltd. (“AnHeart”) is a clinical stage biopharmaceutical company developing novel oncology therapies. AnHeart is headquartered in Hangzhou, China with offices in Beijing, Shanghai and has a subsidiary AnHeart Therapeutics Inc. in New York. Led by a management team with a successful track record of clinical development, AnHeart is developing three clinical stage oncology programs globally. For more information, please visit: https://anhearttherapeutics.com/.
Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people.
Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major diseases therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By Leveraging the this platform, the company has built a robust pipeline of 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 4 products officially approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection), – officially approved for marketing in China, one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, 6 assets in Phase 3 or pivotal clinical trials, and an additional 14 more molecules in clinical trials. In 2019, TYVYT® (sintilimab injection) was the first PD-1 inhibitor included in the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor included in the NRDL in that year.
Innovent has built an international team with advanced talented professionals in high-end biological drug biopharmaceutical development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com.
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info cource: https://www.globenewswire.com/news-release/2021/06/07/2242399/0/en/AnHeart-and-Innovent-Releases-Preliminary-Results-from-the-Phase-II-TRUST-Trial-of-Taletrectinib-in-ROS1-Fusion-Positive-NSCLC-at-the-ASCO-2021-Annual-Meeting.html