US-based biopharmaceutical company Mabwell Therapeutics has received approval from China’s National Medical Products Administration (NMPA) to begin a Phase III clinical trial of 9MW2821 plus Toripalimab for treating urothelial carcinoma.
The randomised, open-label trial will analyse 9MW2821 plus Toripalimab against the investigator’s choice of chemotherapy as a first-line treatment for locally advanced or metastatic urothelial carcinoma.
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Patients who have previously been treated with a PD-(L)1 inhibitor and platinum-containing chemotherapy will be enrolled in the trial.
The study is currently in the enrolment stage. To date, 9MW2821 has been approved for three clinical trials.
The drug is a Nectin-4-targeting antibody-drug conjugate (ADC) that has been independently developed by Mabwell and is the first drug of its kind to enter trials in China targeting the same molecule.
More than 400 subjects have been enrolled across multiple indications for clinical studies of 9MW2821.
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By GlobalDataClinical studies have shown that 9MW2821 has a promising therapeutic efficacy and safety profile.
Mabwell developed the site-specific conjugated novel Nectin-4 targeting ADC using its proprietary ADC platform.
The drug is the first Nectin-4-targeting ADC candidate developed by a Chinese company to begin trials.
The US Food and Drug Administration (FDA) recently granted Fast Track Designation for 9MW2821 for the treatment of various indications.
These indications include advanced, recurrent or metastatic oesophageal squamous cell carcinoma, recurrent or metastatic cell carcinoma that has progressed following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer.
9MW2821 has also received Orphan Drug Designation from the FDA for the treatment of oesophagal cancer, as well as Breakthrough Therapy Designation from the NMPA for locally advanced or metastatic urothelial carcinoma after previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy has failed.
In October last year, Mabwell announced that preliminary data from ongoing clinical studies of 9MW2821 showed “promising” signs.
