Zymeworks' Zanidatamab Aces Mid-Stage Esophageal Cancer Trial

  • At the European Society of Medical Oncology Congress 2021 (ESMO21), Zymeworks Inc ZYME presented encouraging early data on its HER2‑targeted bispecific antibody.
  • Twenty-eight patients were deemed evaluable.
  • Zymeworks’ zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy.
  • The overall disease control rate (DCR) was 89%.
  • There was one complete response and 20 partial responses.
  • Meanwhile, the median duration of response was 16.4 months, with a median progression-free survival of one year across all patients. At the cutoff, 61% of patients were still in the study.
  • Zymeworks plans to pursue a Phase 3 study with the combination of zanidatamab and the chemo regimen known as CAPOX/FP.
  • The combo regime posted a response rate of 93% and DCR of 100%.
  • Zymeworks plans to launch with BeiGene Ltd BGNE HERIZON-GEA-01 study in Q4.
  • The planned trial will test the zanidatamab-CAPOX combo with or without PD-1 inhibitor tislelizumab in a head-to-head matchup with the trastuzumab (Herceptin)-chemo standard of care in first-line advanced GEA.
  • Novartis AG NVS in-licensed tislelizumab from BeiGene in North America, Europe, and Japan.
  • Price Action: ZYME stock is up 5.93% at $34.99 during the market session on the last check Thursday.
  • Check out our coverage of the European Society for Medical Oncology Congress (ESMO21)
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