China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates KN046 and KN026 at the European Society for Medical Oncology (ESMO) 2022 conference. The programs target multiple cancers, including non-small cell lung cancer (NSCLC) and HER2-positive gastric cancer, with results showing promising efficacy and safety profiles.
Study Highlights
- HER2+ Gastric/GEJ Cancer
A Phase II trial enrolled 31 patients with HER2-positive, advanced gastric (GC)/gastroesophageal junction (GEJ) cancer untreated with systemic therapy. Patients received KN026 (30mg/kg Q3W) + KN046 (5mg/kg Q3W). Among 27 evaluable patients:
- ORR: 77.8%
- DCR: 92.6%
- Safety: Mostly grade 1-2 TRAEs; 5 patients had grade ≥3 events.
- First-Line NSCLC (2-Year Follow-Up)
A Phase II study with 23.1-month median follow-up included 51 non-squamous NSCLC patients (KN046 + pemetrexed/carboplatin) and 36 squamous NSCLC patients (KN046 + paclitaxel/carboplatin). Results:
- ORR: 46%
- Median PFS: 5.8 months
- Median OS: 26.6 months
- Platinum-Prereated NSCLC
A trial in 64 patients with metastatic NSCLC who failed first-line platinum therapy showed:
- ORR: 14.1%
- Median PFS: 3.7 months
- Median OS: 18.4 months
- Safety: 42.2% had grade ≥3 TRAEs (infusion reactions, liver dysfunction, pneumonitis).
- EGFR-TKI-Resistant NSCLC
A single-arm Phase II trial in 26 patients with EGFR-mutant NSCLC post-EGFR-TKI failure reported:
- ORR: 26.9%
- DCR: 80.8%
- Median PFS: 5.52 months
- Median OS: 12.68 months
Drug Profiles
- KN046: A PD-1/CTLA-4 bispecific antibody in ~20 trials for NSCLC, TNBC, esophageal, liver, and pancreatic cancers. Cleared for U.S. Phase II trials by FDA.
- KN026: A HER2 bispecific antibody with China/US IND approvals. Licensed to CSPC’s JMT Biotech for development/commercialization in China.-Fineline Info & Tech
