YANTAI, China, November 28, 2023 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, today announced its two open-label, multicenter, single-arm Phase II studies for Disitamab Vedotin (RC48-C005 and RC48-C009) demonstrated consistent efficacy in patients with locally advanced or metastatic HER2-positive urothelial carcinoma (mUC) (3+ or 2+ immunohistochemistry) who progressed over the course of at least one prior line of systemic chemotherapy. The pooled analyzes of these two studies have been published in the latest issue of the world-renowned journal Journal of Clinical Oncology (JCO).
The pivotal phase II trial (RC48-C005, NCT03507166) aimed to evaluate the efficacy and safety of disitamab vedotin in patients with previously treated HER2-positive advanced urothelial carcinoma (UC). Based on initial positive results and guidance from the National Medical Products Administration (NMPA) in China, recruitment for the RC48-C005 trial was prematurely stopped and a subsequent study (RC48-C009, NCT03809013) was conducted to validate the initial results. A combined analysis of the two studies with an NMPA-approved adaptive trial design was necessary to improve the precision of efficacy and safety estimation. Both trials demonstrated promising efficacy and manageable safety profiles for patients with metastatic urothelial carcinoma (mUC) who had previously experienced progression on routine chemotherapy. Based on the robust results of both studies, in January 2022disitamab vedotin received conditional approval in China for patients with mUC resistant to platinum-based therapies.
The company’s CEO, Dr. Jianmin Fang commented“The reported results demonstrate that disitamab vedotin is one of the first HER2-targeted therapies to have significant clinical value against metastatic or locally advanced urothelial cancer. China“Analysis-based studies led to accelerated approval of the drug in China and large international studies (NCT04879329, NCT05911295) initiated by our partner, Seagen Inc., are underway.”
Key results
One hundred and seven patients were enrolled in total and received an IV infusion of 2 mg/kg disitamab vedotin once every two weeks. The primary endpoint was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). Progression-free survival (PFS), overall survival (OS), and safety were also evaluated. The overall ORR confirmed by BIRC was 50.5% (95% CI, 40.6 to 60.3). Consistent results were observed in predefined subgroups including patients with liver metastases and patients previously treated with anti-PD-1/L1 therapies. By the deadline of May 10, 2022, the median duration of response was 7.3 months (95% CI, 5.7 to 10.8). The median PFS and OS were 5.9 months (95% CI: 4.3 to 7.2) and 14.2 months (95% CI: 9.7 to 18.8), respectively. The most common treatment-related adverse events (TRAEs) were peripheral sensory neuropathy (68.2%), leukopenia (50.5%), AST elevation (42.1%), and neutropenia ( 42.1%). Fifty-eight (54.2%) patients experienced grade ≥3 TRAEs, including peripheral sensory neuropathy (18.7%) and neutropenia (12.1%).
Locally advanced or metastatic urothelial carcinoma (UC) has a poor prognosis, with only approximately 5% of stage IV (metastatic) patients surviving more than five years. Platinum-based chemotherapy remains the first-line standard of care for advanced UC with historically objective response rates (ORR) of 44.6% to 72% and median overall survival (mOS) of 14.0 to 15 ,2 months.
“We are firmly committed to providing effective and safe treatment options to prolong and improve the quality of life of patients with locally advanced or metastatic HER2-positive urothelial cancer. In these studies, we were pleased to see that disitamab vedotin showed consistent and manageable efficacy. safety in patients with chemotherapy-refractory mUC,” said the studies’ principal investigator, Dr. Guo Jun.
About RemeGen Co. Ltd.
Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening diseases. RemeGen has laboratories and research offices throughout China and the UNITED STATES. The Company is committed to discovering, developing and commercializing innovative and differentiated biologic medicines with significant clinical value in the key therapeutic areas of autoimmune, oncology and ophthalmic diseases.
For more details, please visit: www.remegen.com
About Disitamab Vedotin (RC48)
Disitamab Vedotin (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent cancers with high unmet medical need and is the first domestically developed ADC to receive marketing approval in China. The drug was granted conditional marketing approval in June 2021 by the National Medical Products Administration (NMPA) in China to treat locally advanced or metastatic gastric cancer. The same month, the company submitted an investigational new drug (IND) application for the treatment of advanced or metastatic HER2-expressing urothelial carcinoma with disitamab vedotin. In 2021, RemeGen and Seagen Inc. entered into an exclusive global licensing agreement to develop and commercialize disitamab vedotin.
The Company is implementing a differentiated development and commercial strategy for disitamab vedotin, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC) and ( iv) other cancers expressing HER2. cancers.
Forward-looking statements
This press release may contain certain forward-looking statements which, by their nature, are subject to significant risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to RemeGen, are intended to identify such forward-looking statements . RemeGen does not intend to regularly update these forward-looking statements. These forward-looking statements are based on RemeGen’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such 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 RemeGen’s control and are difficult to predict. Therefore, actual results may differ materially from the information contained in the forward-looking statements due to future changes or developments in our business, RemeGen’s competitive environment and political, economic, legal and social conditions.
RemeGen, the directors and employees of RemeGen undertake (a) no obligation to correct or update any forward-looking statements contained on this site; and (b) no liability if any of the forward-looking statements fail to materialize or prove to be incorrect.
View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/remegen-announces-publication-of-results-from-two-phase-ii-studies-for-disitamab-vedotin-in-latest-issue-of- journal-of-clinical-oncology-jco-301998518.html
SOURCE RemeGen Co., Ltd
