Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the "A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy" has been approved.

The company will initiate the Phase III clinical study to assess the efficacy and safety of 9MW2821 in patients with recurrent or metastatic cervical cancer (CC) that has progressed on or after platinum-based chemotherapy.

9MW2821, a novel Nectin-4 targeting ADC developed by Mabwell, is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. It's also the first Nectin-4-targeting ADC to enter phase III clinical study for the treatment of CC worldwide. Multiple clinical studies have been conducted for urothelium carcinoma, cervical cancer, esophageal cancer, and breast cancer, and more than 400 subjects have been enrolled. The results of the existing clinical studies have demonstrated outstanding therapeutic efficacy and safety.

Treatment options and outcomes for patients with recurrent or metastatic cervical cancer remain limited. In the cervical cancer expansion cohort of the phase I/II study, the detection rate of Nectin-4 expression was 91.87%, and the detection rate of Nectin-4 IHC 3+ was 73.98%. 53 CC patients received at least one dose of 9MW2821 and were evaluable for efficacy assessment. All of the patients had received doublet platinum-containing chemotherapy, 51% patients had received bevacizumab, and 58% patients had received immune checkpoint inhibitor. ORR and DCR in 53 CC patients were 35.8% and 81.1%, respectively. The median progression-free survival (mPFS) and duration of response (DOR) was 3.9 months and 7.2 months, respectively. Median overall survival (OS) was not reached yet and 12-months OS rate was 74.6%. Among patients with Nectin-4 IHC 3+, the ORR was 43.6%.

The results of the above studies indicate that 9MW2821 has a positive therapeutic effect in patients with cervical cancer. The company is in the process of scientifically evaluating and advancing the conduct of clinical studies on first-line combination therapies.