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OSI Pharmaceuticals and Genentech Announce Supplemental New Drug Application for Tarceva in Pancreatic Cancer Treatment

Strategic Insights

— 2 min read

OSI Pharmaceuticals, Inc. and Genentech, Inc. have submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Tarceva (erlotinib) in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment. This application is based on a pivotal Phase III trial that demonstrated a 23.5 percent improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to those receiving gemcitabine plus placebo.

The Phase III trial, which involved 569 patients, showed that patients receiving Tarceva plus gemcitabine had a median survival of 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm. Additionally, 24 percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo. An exploratory analysis of survival by pre-treatment characteristics also showed that patients with metastatic disease and patients with poor performance status derived a significant survival benefit.

The most common adverse reactions in patients receiving Tarceva were rash and diarrhea, which were reported by 72 percent and 51 percent of patients, respectively. Rash and diarrhea each resulted in discontinuation of one percent of Tarceva-treated patients. Historically, there have been infrequent reports of serious interstitial lung disease (ILD) in patients receiving Tarceva, including fatalities.

Key Takeaways:

  • OSI Pharmaceuticals and Genentech have submitted a supplemental New Drug Application (sNDA) to the FDA for the use of Tarceva in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer.
  • The Phase III trial demonstrated a 23.5 percent improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to those receiving gemcitabine plus placebo.
  • Patients receiving Tarceva plus gemcitabine had a median survival of 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm.
  • 24 percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo.
  • Tarceva is the first drug to significantly improve survival in a Phase III trial when added to gemcitabine chemotherapy in first-line pancreatic cancer.
  • The most common adverse reactions in patients receiving Tarceva were rash and diarrhea.
  • Interstitial lung disease (ILD) was experienced by 2.1 percent of patients in the Tarceva plus gemcitabine arm compared with 0.4 percent in the gemcitabine plus placebo arm.

Statistics:

  • 569 patients were randomized in the Phase III trial.
  • 23.5 percent improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to those receiving gemcitabine plus placebo.
  • Median survival in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm.
  • 24 percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo.

Sources:

  • OSI Pharmaceuticals, Inc.
  • Genentech, Inc.
  • World Health Organization
  • American Cancer Society

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