Innovent and AnHeart Announce Interim Data from Phase 2 Trial of Taletrectinib in ROS1-Positive NSCLC at the CSCO 2021 Annual Meeting
SAN FRANCISCO?and SUZHOU,?China,?Sept. 26, 2021?/PRNewswire/ -- 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, and AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, today jointly announced the interim clinical data from a Phase 2 trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on?September 25-29, 2021.
The scientific presentation entitled: "Taletrectinib (AB-106): Preliminary results from TRUST, Phase 2 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 2 trial of taletrectinib (NCT04395677).
As of?June 16, 2021, 21 crizotinib treatment-na?ve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1?fusion-positive. The?key results are as follows:
BYVASDA? (bevacizumab biosimilar injection), HALPRYZA? (rituximab biosimilar injection), and SULINNO? (adalimumab biosimilar injection) are not approved products in?the United States.
TYVYT? (sintilimab injection, Innovent)
BYVASDA? (bevacizumab biosimilar injection, Innovent)
HALPRYZA? (rituximab biosimilar injection, Innovent)
SULINNO? (adalimumab biosimilar injection, Innovent)
Pemazyre? (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre? was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China,?Hong Kong,?Macau?and?Taiwan. Disclaimer: 1. This indication hasn't been approved in?China.
2. Innovent does not recommend any off-label usage.
3.?For medical and healthcare professionals only. About AnHeart AnHeart Therapeutics Co., Ltd. ("AnHeart") is a clinical-stage biopharmaceutical company developing novel first-in-class or best-in-class precision oncology therapeutics. Its lead asset, taletrectinib, is a next-generation ROS1 and NTRK inhibitor currently in Phase 2 trials for the first and second-line non-small cell lung cancer (NSCLC) . AnHeart is developing a broad pipeline of next-generation precision oncology therapeutics with high unmet medical need. For more information, please visit?www.anhearttherapeutics.com. Innovent Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. AnHeart Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends," or "continue," or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. SOURCE Innovent Biologics
- In the crizotinib treatment-na?ve 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.
BYVASDA? (bevacizumab biosimilar injection), HALPRYZA? (rituximab biosimilar injection), and SULINNO? (adalimumab biosimilar injection) are not approved products in?the United States.
TYVYT? (sintilimab injection, Innovent)
BYVASDA? (bevacizumab biosimilar injection, Innovent)
HALPRYZA? (rituximab biosimilar injection, Innovent)
SULINNO? (adalimumab biosimilar injection, Innovent)
Pemazyre? (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre? was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China,?Hong Kong,?Macau?and?Taiwan. Disclaimer: 1. This indication hasn't been approved in?China.
2. Innovent does not recommend any off-label usage.
3.?For medical and healthcare professionals only. About AnHeart AnHeart Therapeutics Co., Ltd. ("AnHeart") is a clinical-stage biopharmaceutical company developing novel first-in-class or best-in-class precision oncology therapeutics. Its lead asset, taletrectinib, is a next-generation ROS1 and NTRK inhibitor currently in Phase 2 trials for the first and second-line non-small cell lung cancer (NSCLC) . AnHeart is developing a broad pipeline of next-generation precision oncology therapeutics with high unmet medical need. For more information, please visit?www.anhearttherapeutics.com. Innovent Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. AnHeart Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends," or "continue," or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. SOURCE Innovent Biologics