Aphton Corporation Announces Positive Results of Phase II Study on G17DT Immunogen in Treating Gastric and Gastroesophageal Cancer

Strategic Insights -

Aphton Corporation, a biopharmaceutical company, announced significant positive results from a multicenter Phase II study on its G17DT Immunogen in combination with cisplatin and 5-Fluorouracil (5-FU) in chemotherapy-naive patients with locally recurrent or metastatic gastric and gastroesophageal cancer. The study, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated a 51% best overall tumor response rate and a median survival of 8.9 months for patients treated with the combination. Notably, patients who developed antibodies to G17DT had a significantly improved median survival of 10.8 months, compared to 6.2 months for non-responders.

Key Takeaways:

  • The Phase II study, conducted on 103 chemotherapy-naive patients with advanced gastric or gastroesophageal cancer, demonstrated a 51% best overall tumor response rate.
  • Patients treated with G17DT in combination with cisplatin and 5-FU had a median survival of 8.9 months.
  • Patients who developed G17DT antibodies had a significantly improved median survival of 10.8 months, compared to 6.2 months for non-responders.
  • The addition of G17DT did not exacerbate the systemic toxicity profile of cisplatin and 5-FU.
  • The study's results provide a separate indication that survival benefit was not solely a function of health status.
  • Multivariate analysis showed the immune response to G17DT as an independent predictor of tumor response and survival.
  • One patient with partial response converted to complete response after additional G17DT treatment in an extension protocol.

Statistics:

  • 51% best overall tumor response rate based on RECIST criteria
  • 8.9 months median survival for patients treated with G17DT in combination with cisplatin and 5-FU
  • 10.8 months median survival for patients who developed G17DT antibodies
  • 6.2 months median survival for patients who did not develop G17DT antibodies
  • 76% of patients generated anti-G17 antibodies
  • 24% of patients did not generate anti-G17 antibodies

Sources:

  • Business Wire, Aphton Corporation, "Aphton Corporation Presents Results of Phase II Study of G17DT Immunogen in Combination with Cisplatin and 5-Fluorouracil in Chemotherapy-Naive Patients with Locally Recurrent or Metastatic Gastric and Gastroesophageal Cancer", June 7, 2004
  • American Society of Clinical Oncology (ASCO) Annual Meeting, "Gastrointestinal (Noncolorectal) Cancer" poster session, June 5, 2004