Another pivotal-stage EGFR conjugate

Fresh from scoring a first-in-human clinical trial presentation at AACR for SYS6010, CSPC Pharmaceuticals is taking this anti-EGFR ADC into its first phase 3 trial. This will be relevant for ALX Oncology, which recently entered the EGFR ADC field with ALX2004, and for Lepu Biopharma, whose pivotal phase 2 study of the similarly acting MRG003 has apparently been selected for an ASCO late-breaker, according to a somewhat premature press release. CSPC's SYS6010 is one of just five clinical-stage monospecific EGFR-directed ADCs, and is already in a study described on the Chinese trials registry as a phase 1b/3; this is apparently uncontrolled, testing a Tagrisso combo in patients with unspecified NSCLC. However, the new study, just revealed on clinicaltrials.gov, is a bona fide phase 3 with a chemo comparator cohort. It will test SYS6010 monotherapy in 380 patients with EGFR-mutated NSCLC who have already failed an anti-EGFR kinase inhibitor like Tagrisso, and test PFS as primary endpoint. In lung cancer CSPC looks to have a fairly clear path for SYS6010; the only other anti-EGFR ADC in clinical trials for NSCLC is Lepu's MRG003, though the pivotal focus for that molecule is nasopharyngeal cancer.

Selected trials of SYS6010/CPO301

Source: OncologyPipeline.