China-based Mabwell (688062.SH, 02493.HK) reported early-stage clinical data for its Nectin-4-targeting antibody-drug conjugate 9MW2821 (bulumtatug fuvedotin, BFv) in cervical cancer at the ESMO Gynaecological Cancers Congress in Copenhagen, with results that position the molecule as a potential competitor to Pfizer's Tivdak (tisotumab vedotin) in the post-platinum setting — and, more ambitiously, as a first-line combination option if later-stage data hold.
The monotherapy arm of NCT05216965, a Phase I/II study in recurrent or metastatic cervical cancer, enrolled 55 patients who had progressed on platinum-based chemotherapy with or without bevacizumab. Among 53 efficacy-evaluable patients, the confirmed objective response rate (cORR) was 32% and the disease control rate reached 81%. The headline survival figure — a median overall survival of 19.4 months, with a 24-month OS rate of 49% — is notable for a heavily pretreated population, though the single-arm design and modest sample size preclude direct comparison with approved agents. Cross-trial comparisons are limited, but tisotumab vedotin's Phase III innovaTV 301 trial, which supported full FDA approval in April 2024, reported a median OS of approximately 11.5 months versus 9.5 months for chemotherapy in a similar post-platinum population.
Combination data draw more attention
A second potentially commercially significant dataset came from a Phase Ib/II study pairing BFv with Junshi Biosciences' Loqtorzi (toripalimab), a PD-1 inhibitor approved by the US FDA for nasopharyngeal carcinoma but not for cervical cancer. Among 13 efficacy-evaluable patients — a very small cohort — the ORR was 77% and the disease control rate reached 100%. In the 10 treatment-naïve patients evaluable for response, the ORR was 80%. Adverse events were predominantly Grade 1–2, with no new safety signals identified.
These numbers, while preliminary, are relevant because the first-line cervical cancer setting is currently anchored by Merck's Keytruda (pembrolizumab) combined with platinum-based chemotherapy with or without Roche's Avastin (bevacizumab), an approach restricted to patients with PD-L1 CPS ≥1. A chemotherapy-free ADC plus PD-1 combination that could demonstrate durable responses regardless of biomarker status would address a genuine gap — though the 13-patient efficacy dataset reported here is far too small to draw conclusions about clinical positioning.