Promising Results for Introgen's Cancer Vaccine INGN 225 in Phase II Trial

Strategic Insights -

Advanced small cell lung cancer (SCLC) patients who received Introgen Therapeutics' investigational cancer vaccine, INGN 225, showed a significantly higher response rate to second-line chemotherapy compared to historical controls. The results of the phase II trial, presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO), indicate that 67% of patients who received INGN 225 had an objective response (more than 50% tumor reduction) to subsequent chemotherapy.

Key Takeaways:

  • INGN 225, a therapeutic vaccine consisting of dendritic cells treated with the human p53 gene, was well tolerated in the trial, with no appreciable toxicity noted.
  • 12 out of 18 patients with progressive disease who received INGN 225 followed by second-line chemotherapy showed an objective response or tumor reduction greater than 50%, compared to a historically expected rate of 20-30%.
  • A statistically significant correlation was found between the development of a p53 immunological response to vaccination and objective responses to second-line chemotherapy (p = 0.032).
  • Patients with highly aggressive disease (platinum-resistant) showed improved response rates and increased survival compared to historical controls.
  • INGN 225 may sensitize tumors to the effects of chemotherapy, including platinum and taxane chemotherapies, making it a promising finding for the future treatment of SCLC.
  • Introgen is also developing ADVEXIN, an Ad-p53 formulation for the treatment of various cancers.

Statistics:

  • 67% of evaluable patients in the study had an objective response to second-line chemotherapy following INGN 225 treatment.
  • 12 out of 18 patients (66.7%) showed an objective response or tumor reduction greater than 50% after receiving INGN 225 followed by second-line chemotherapy.
  • 20-30% is the historically expected objective response rate in patients with advanced SCLC.
  • 0.032 is the p-value for the correlation between p53 immunological response to vaccination and objective responses to second-line chemotherapy.

Sources:

  • Abstract #2543, 41st Annual Meeting of the American Society of Clinical Oncology (ASCO)
  • Health & Medicine Week editors, "Introgen Therapeutics' INGN 225 Shows Promising Results in Phase II SCLC Trial", Health & Medicine Week
  • NewsRx.com, "Introgen Therapeutics, Inc. (INGN) Reportedly Files Patent Application for Peptide Technology to Enhance the Delivery of Gene-based Cancer Vaccines", NewsRx.com