Corbus eyes a Nectin-4 pivotal first
Though the first phase 3 trial of the anti-Nectin-4 ADC SYS6002 won’t be sponsored by Corbus, expect the US biotech to be paying close attention to it. Not only will this study, just revealed on clinicaltrials.gov, be SYS6002’s first pivotal test, it will be only the second phase 3 trial of any anti-Nectin-4 ADC in cervical cancer. That’s relevant for Corbus, which licensed SYS6002 from its originator, CSPC Pharmaceutical, for $7.5m up front in 2023, and which has marked cervical cancer as one setting for a dose-optimisation study. For its part, CSPC is now taking SYS6002 monotherapy into a chemo-controlled phase 3 trial in 412 patients who have failed on platinum chemo and anti-PD-(L)1 therapy. Backing for this trial came from CSPC’s Chinese multi-tumour study, in which three of seven cervical cancer patients responded. So far Corbus has broadly managed to replicate the data in its own Western trial, which included one partial response among two cervical cancer patients. Pfizer/Astellas’s Padcev remains the only marketed anti-Nectin-4 ADC, but its approvals have come in bladder cancer. The only other similarly acting project in pivotal cervical cancer development, according to OncologyPipeline, is Mabwell’s bulumtatug fuvedotin.
Phase 3 trials of anti-Nectin-4 ADCs in cervical cancer
| Project | Company | Study | Primary endpoint |
|---|---|---|---|
| Bulumtatug fuvedotin | Mabwell | Monotherapy, 420 patients progressed after chemo | OS vs chemo |
| SYS6002 | CSPC Pharmaceutical* | Monotherapy, 412 patients progressed on chemo and anti-PD-(L)1 therapy | OS vs chemo |
Note: *licensed to Corbus under the code CRB-701. Source: OncologyPipeline.
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