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Highlights from Mabwell's Presentation on 9MW2821 at ASCO 2025

On June 5, 2025, during the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, results from a pivotal clinical study of Mabwell's 9MW2821 were shared by Professor Xinan Sheng. This trial focused on the efficacy of 9MW2821, a next-generation antibody-drug conjugate (ADC) targeting Nectin-4, in combination with Toripalimab for patients suffering from locally advanced or metastatic urothelial carcinoma (la/mUC).

Background on Urothelial Carcinoma

Urothelial carcinoma is a widespread malignant tumor, with bladder cancer accounting for a significant burden globally. According to 2024 data, around 614,000 new cases and 220,000 deaths occur each year, indicating a pressing need for effective treatments. The disease disproportionately affects men, marking it as the sixth most prevalent cancer and the ninth leading cause of cancer-related deaths among males.

About 9MW2821 and Toripalimab

9MW2821, also known as Bulumtatug Fuvedotin (BFv), has demonstrated encouraging outcomes in patients who have shown progression after traditional therapies involving platinum-based chemotherapy and immune checkpoints. The clinical research team reported the first detailed results regarding the safety and efficacy of 9MW2821 combined with Toripalimab for treating la/mUC, marking a significant moment in oncology. Toripalimab, a humanized anti-PD-1 monoclonal antibody, is recognized for its efficacy and has been approved in multiple countries, including the USA and China.

Study Design

This phase Ib/II study involved a multicenter, open-label design conducted across various sites in China. Patients received treatments every three weeks, where 9MW2821 was administered at doses of 1.0 or 1.25 mg/kg, complemented by a 240 mg dose of Toripalimab on the first day of the cycle. The therapy continued until disease progression or unacceptable toxicity was observed.

Key Findings

As of April 30, 2025, the study included 52 patients with la/mUC, with 40 patients deemed assessable for evaluation. Amongst these participants, the median age was 67, with 70% being male. A notable 82.5% were found to be Nectin-4 positive, and 20% exhibited PD-L1 positivity.

The results highlighted an impressive Objective Response Rate (ORR) of 87.5%. More specifically, 80% of responses were confirmed, with a complete response rate of 12.5%. Additionally, a Disease Control Rate (DCR) reached 92.5%, indicating substantial tumor reduction in 97.5% of the assessable patients, with 57.5% demonstrating a reduction of more than 50%. Notably, the ORR across various subgroups remained consistent, indicating that the treatment is beneficial regardless of primary tumor site or the expression levels of Nectin-4 and PD-L1.

Furthermore, the study noted that as of the reporting date, 45% of the participants had experienced disease progression or death—highlighting a median progression-free survival time of 12.5 months. Notably, adverse events related to treatment occurred in 98.1% of patients, with most being of grade 1-2 severity and none leading to mortality, denoting a favorable safety profile for both drugs in this combination.

Conclusion

The study concludes positively, suggesting that the combination of 9MW2821 with Toripalimab showcases not only a promising therapeutic avenue for la/mUC but also affords a new treatment option particularly for patients who may not respond well to traditional chemotherapy treatments. The ongoing pivotal phase 3 study comparing this combination with platinum-based chemotherapy further emphasizes Mabwell's commitment to advancing cancer treatment strategies.

About Mabwell

Mabwell is a pioneering biopharmaceutical firm, orchestrating a comprehensive value chain within the medical industry. The company emphasizes the development of innovative therapies that improve patient outcomes and meet pressing global healthcare needs. With a pipeline that includes 16 products at various development stages and significant recognition for its drug candidates, Mabwell is set to revolutionize treatment practices in oncology and beyond.

For more insights, visit Mabwell's Official Website.