Lepu starts another pivotal conjugate trial

The EGFR-targeting ADC arena is heating up, if recent trial initiations are anything to go by, and the latest phase 3 features Lepu Biopharma’s becotatug vedotin (MRG003). The Chinese Magic-C002 study, just posted on clinicaltrials.gov and slated to start this month, will enrol patients with second-line nasopharyngeal carcinoma and test becota-v plus Lepu’s anti-PD-1 MAb pucotenlimab, versus chemo. An important readout for the project will soon come at ASCO, where data from a phase 2 trial testing becota-v monotherapy in a similar setting will feature in a late-breaking session. At ESMO 2023, the same phase 2 produced ORRs of 39% and 55% with 2.0mg/kg and 2.3mg/kg respectively. Lepu has another Chinese phase 3 of becota-v ongoing, in second/third-line head and neck cancer, which is due to complete in August. It’s not the only pivotal player in this space: CSPC Pharmaceuticals recently started a pivotal trial of its contender, SYS6010, in NSCLC, while phase 3 head and neck results with Rakuten’s cetuximab sarotalocan are due this year. Others are taking a dual approach, like Bristol Myers Squibb and SystImmune, partnered on the EGFR x HER3-targeting izalontamab brengitecan, which will soon begin its first global pivotal trial, Izabright-Breast01.

EGFR-targeting ADCs in phase 3

Note: *Anti-EGFR x HER3 ADC. Source: OncologyPipeline & clinicaltrials.gov.