Toripalimab

SHANGHAI, June 5, 2025 /PRNewswire/ -- At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, from May 30 to June 3, the results of the Phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) were presented by Prof. Xinan Sheng, Chief Physician of the Department of Urologic Oncology, Beijing Cancer Hospital, on behalf of the research team, with key highlights as below: Oral Presentation Background: Urothelial carcinoma (UC) is a common malignant tumor worldwide. Global cancer statistics released in 2024 showed that bladder cancer is the ninth most commonly diagnosed cancer in the world, with about 614,000 new cases and 220,000 deaths annually. The burden and morbidity of bladder cancer is significantly higher in men than in women. It is the sixth most common cancer and the ninth leading cause of cancer death in men [1]. 9MW2821 (Bulumtatug Fuvedotin, BFv) is a next-generation Nectin-4 targeting antibody-drug conjugate. Previous study of BFv has shown promising efficacy in la/mUC patients who progressed on/after platinum-based chemotherapy and immune checkpoint inhibitors [2]. A pivotal phase 3 study of BFv is ongoing in China (NCT06196736, CTR20234024). Toripalimab is a novel recombinant humanized anti-PD-1 monoclonal antibody that has been approved in multiple countries including China and the USA. It is the first time to report in detail on the efficacy and safety of 9MW2821 in combination with Toripalimab in patients with la/mUC. Method: This is a phase Ib/II, open-label, multicenter study of BFv and Toripalimab in la/mUC in China. Every 21 days per cycle, patients received BFv (1.0 or 1.25mg/kg, on day 1 and 8) and Toripalimab (240mg, on day 1). Treatment until disease progression or unacceptable toxicity. Results: As of Apr. 30, 2025, 52 patients with la/mUC were enrolled. Among the 40 assessable patients (treatment-naive for la/mUC) with the median age of 67, 70% of patients were male, 72.5% had an Eastern Cooperative Oncology Group (ECOG) score of 1, 55% with tumor primary site at upper urinary tract, 15% had liver metastases, 82.5% were Nectin-4 positive and 20% were PD-L1 positive. The Objective Response Rate (ORR) was 87.5% (95% CI: 73.2, 95.8), confirmed ORR was 80%, complete response (CR) rate was 12.5%, Disease Control Rate (DCR) was 92.5% (95% CI: 79.6, 98.4). 97.5% of assessable patients had tumor reduction, 57.5% of assessable patients had tumor reduction of 50% above. The ORR in selected subgroups was consistent with results in overall population. Different subgroups of treatment-naive patients could benefit from BFv and Toripalimab regardless of primary tumor site, liver metastasis, expression of Nectin-4 and PD-L1. The ORR was 100% (24/24) in patients older than 65, 94.44% (17/18) in patients with tumor primary site at lower urinary tract, 83.33% (5/6) in patients with liver metastasis, 100% (7/7) in nectin-4 negative patients, and 100% (8/8) in PD-L1 positive patients. As of April 30, 2025, 45% (18/40) of subjects experienced disease progression or death, with a median progression-free survival (mPFS) of 12.5 months (95% CI: 6.47-NA), and a median duration of response (mDoR) that has not been reached. Median follow-up time was 10.8 months, thus mPFS and mDoR was not mature. The incidence rate of treatment-related adverse events (TRAE) was 98.1%, and most of the TRAEs were grade 1-2. The incidence rate of TRAEs ≥grade 3 was 42.3%, mainly characterized by neutrophil counts decreased (11.5%), alanine aminotransferase increased (5.8%), and white blood cell decreased (5.8%). The incidence rate of serious TRAEs was 28.8%, and no TRAEs leading to death occurred. BFv and Toripalimab showed well-tolerated safety profile. No new safety signals of BFv or Toripalimab were observed in this study. Conclusion: BFv combined with Toripalimab has demonstrated encouraging efficacy and manageable safety profile in la/mUC. Patients with advanced age, liver metastases and negative expression of Nectin-4 also achieved considerable response in this study, suggesting that BFv in combination with Toripalimab may provide a new treatment option for patients with advanced UC who are intolerant of or potentially have a poor prognosis with platinum-based chemotherapy. A pivotal phase 3 study of BFv combined with Toripalimab vs platinum-based chemotherapy is ongoing in China (NCT06592326, CTR20242828). About 9MW2821 9MW2821 is a novel Nectin-4 targeting ADC, which achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process of Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for UC have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 4 products have been approved and commercialized, 1 product filed for pre-NDA meeting, 2 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. 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YANTAI, China, June 2, 2025 /PRNewswire/ -- On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement, potentially to benefit patients who are non-responders to traditional targeted therapies. The data presented are from the Phase 2 part of a randomized, multi-cohort, seamlessly connecting Phase 2/3 study, which enrolled systematic chemotherapy-native patients with different HER2 expression levels. As of April 7, 2025, the results showed: Among HER2-overexpressing gastric cancer patients, compared to the PD-1-trastuzumab-CAPOX combination therapy, DV and PD-1 + chemotherapy as well as DV and PD-1 + trastuzumab both demonstrated statistically significant efficacy and favorable safety profiles. Objective response rate (ORR): 66.7% vs 82.4% vs 68.8%; Median progression-free survival (mPFS): NR vs NR vs 14.1 months, with risk of disease progression decreasing by 54%（HR=0.46）and 41% (HR: 0.59); 12-month PFS rate: 66.3%, 67% and 53.6%； Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. In patients with HER2-low-expressing gastric cancer, promising efficacy was observed with DV + PD-1 + CAPOX comparing to PD-1 + CAPOX, with a manageable safety profile. ORR: 72.0% vs 47.8%; mPFS: 9.9 vs 7.2 months, with risk of disease progression decreasing by 31% (HR: 0.69); Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. Dose optimization conducted in patients with HER2-median/low-expressing gastric cancer. Compared to PD-1 + CAPOX, DV at 2.5 mg/kg or 2.0 mg/kg combined with PD-1 + reduced-dose CAPOX showed significant efficacy, and better safety over the full-dose chemotherapy. ORR: 71.4% vs 66.7% vs 56.3%; 6-month PFS rate: 71.4%，72.7% and 53.3%. Globally, this is the first study to explore the triple combination therapy of "HER2 ADC + PD-1 + targeted medication" as first-line treatment of patients with la/m gastric cancer, pioneering a new mode of synergistic therapy. The multi-cohort design of this study provides precision treatment regimen for gastric cancer patients with different level of HER2 expression. For the HER2-overexpressing gastric cancer patients, DV + PD-1 + trastuzumab has the potential to become the new standard first-line treatment; for the HER2-low-expressing gastric cancer patients, DV + PD-1 + chemotherapy has the potential to fill the treatment gap of these patients. Based on the data obtained from the phase 2 study, the phase 3 clinical study of the triple combination therapy in patients with HER2-median/low-expressing gastric cancer has been initiated in April, 2025, in which 616 participants were planned to be enrolled, to further validate the efficacy of the DV combination therapy. Gastric cancer is the fifth most common malignant tumor in the world, and China accounts for about 42.6% of new cases and 45.0% of deaths worldwide. HER2 is an important target in the treatment of gastric cancer, while the traditional targeted drug trastuzumab is only effective in the population with high expression (IHC 3+ or IHC 2+/FISH+), and can easily become resistant. There is a lack of effective targeted therapy options for patients with low/median HER2 expression (IHC 1+ or IHC 2+/FISH-), and the efficacy of chemotherapy combined with immunotherapy is not satisfactory. As the first domestic HER2-targeted ADC drug in China, DV not only precisely kills tumor cells with HER2 over expression but also attacks adjacent cells with HER2 low expression through the bystander effect. Preclinical studies have also shown that the combination of DV with PD-1 inhibitor and trastuzumab can enhance anti-tumor activity. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED