KEY TAKEAWAYS
- The phase 1 & 2 trial aimed to investigate the efficacy and safety of 9MW2821, a monoclonal ADC, in patients with R/M CC.
- The primary endpoint was to determine ORR.
- Researchers noticed promising antitumor activity and acceptable safety of 9MW2821 monotherapy in patients with R/M CC; further investigation is ongoing.
Treatment options and outcomes for patients with recurrent or metastatic (R/M) cervical cancer (CC) are often inadequate. 9MW2821, a monoclonal antibody-drug conjugate (ADC) targeting Nectin-4, presents a novel therapeutic approach.
Huijuan Yang and the team aimed to evaluate the efficacy and safety 9MW2821, specifically in patients with CC.
They performed an inclusive analysis in this multi-center, open-label, single-arm, phase I/II study, which enrolled patients with Nectin-4-positive R/M CC. Patients, who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease, were eligible for enrollment.
Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8, and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects, or withdrawal from the study. The primary endpoint was the objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (version 1.1). Key secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
About 40 patients received at least one dose of 9MW2821 as of Sep 25, 2023. The median age was 52 years (range: 33-64 years), with 40% of patients having received two prior lines of systemic therapy. Among them, 82.5% had squamous cell disease, 77.5% had an ECOG score of 1, 57.5% had received bevacizumab, and 60.0% had received immune checkpoint inhibitors.
The median follow-up time was 5.60 months (range: 1.08-8.97 months). In 37 evaluable patients, the ORR was 40.54% (95% CI, 24.75% to 57.90%), and the DCR was 89.19% (95% CI, 74.58% to 96.97%), with one complete response (2.70%) and 14 partial responses (37.84%). Median PFS, overall survival (OS), and DoR were not reached.
Treatment-related adverse events (TRAEs) occurred in 92.50% of participants, with grade 3-4 TRAEs reported in 70.00% of participants, including neutropenia (40.00%), rash (17.50%), and gamma-glutamyltransferase increased (12.50%). No deaths related to treatment were reported.
The study concluded that 9MW2821 monotherapy exhibited promising antitumor activity and acceptable safety profiles in patients with previously treated R/M CC. Further investigation of 9MW2821 in this patient population is deemed necessary and warranted.
The trial was sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.
Source: https://sgo.planion.com/Web.User/AbstractDet?ACCOUNT=SGO&ABSID=450631&CONF=AM2024&CKEY=
Clinical Trial: https://clinicaltrials.gov/study/NCT05216965
Yang H, Zhang J, Liu R, et al. (2024). “Efficacy and safety of 9MW2821, an antibody-drug conjugate targeting Nectin-4 monotherapy, in patients with recurrent or metastatic cervical cancer: A multicenter, open-label, phase I/II study.” Presented at SGO 2024.
