LCB14 (HER2 ADC, Licensed to Fosun Pharma) Gastric Cancer Phase 2 Result Released

LCB14 (HER2 ADC, Licensed to Fosun Pharma) Gastric Cancer Phase 2 Results Released in ASCO2024

ASCO2024 LCB14 (FS-1502) Abstract  : 
FS-1502(LCB14) in patients with HER2 high expression, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma: An open-label, multicenter, phase II study).
Program Guide – ASCO Meeting Program Guide

FS-1502 was administered at a dose of 2.3 mg/kg every three weeks to HER2-positive patients. The Phase 2 trial consisted of two cohorts: Cohort 1 included patients who had received two or more prior treatments, and Cohort 2 included patients who had only received first-line therapy.

Efficacy Results:

• Cohort 1 (N=16):
  • ORR: 37.5%
  • mPFS: 4.3 months
  • OS: 10.0 months
  • Comparable to Enhertu's DESTINY-Gastric06 trial with ORR 35.6%, mPFS 5.7 months, OS 10.2 months.
• Cohort 2 (N=19):
  • ORR: 52.6%
  • mPFS: 4.4 months
  • DOR: 8.3months
  • OS: 14.6 months
  • Superior to Enhertu's DESTINY-Gastric02 trial with ORR 42%, mPFS 5.6 months, DOR 8.1months, OS 12.1 months, except for mPFS.

Safety Results:

• FS-1502 demonstrated an excellent safety profile with no patients discontinuing treatment due to drug-related adverse events.
• Grade 3 or higher adverse events occurred in 12 patients (26.1%), mainly hypokalemia (6.5%) and fatigue (6.5%).
• No deaths related to drug side effects.
• In contrast, Enhertu had 56% of patients experiencing Grade 3 or higher adverse events, with 19% discontinuing treatment and two deaths due to drug-related interstitial lung disease and pneumonia.

Market Potential:

• FS-1502 is being recognized as a potential alternative to Enhertu in the global ADC cancer drug market.
• Unlike most HER2 ADC competitors using exatecan, FS-1502 uses MMAF.
• FS-1502 targets the market for patients with exatecan resistance and those experiencing side effects from Enhertu.

Previous and Ongoing Trials:

• FS-1502 had previously attracted attention at ASCO 2023 for showing similar efficacy and superior safety compared to Enhertu in a Phase 1 breast cancer trial.
• The consistent superior therapeutic effects of FS-1502 over competing drugs have been confirmed in both breast and gastric cancer.
• FS-1502 is currently undergoing multiple Phase 2 trials in China for various solid tumors, including a Phase 3 trial comparing it to Kadcyla in HER2-positive breast cancer patients. PR reference :  [약업신문]리가켐바이오 포순제약 L/O 위암 ADC 신약후보 2상서 엔허투 대체 가능성 확인 (yakup.com)