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Coulter Pharmaceutical Announces Preliminary Data on Bexxar in Combination with Chemotherapy and Stem Cell Transplantation for Non-Hodgkin's Lymphoma

Strategic Insights

— 2 min read

Preliminary data from an investigational clinical trial with high doses of Bexxar in combination with chemotherapy and stem cell transplantation in non-Hodgkin's lymphoma patients have demonstrated the potential of Bexxar to be safely and effectively combined with chemotherapy and autologous stem cell transplantation to treat patients with relapsed NHL. The data, presented at the 34th Annual ASCO meeting, showed that 31 of 42 evaluable patients (74 percent) were progression-free after a median follow-up of 1.5 years, with manageable toxicities at dose levels below 25 Gy to normal organs.

Key Takeaways:

  • The clinical trial enrolled 43 relapsed NHL patients, with 28 (65 percent) having low-grade and 15 (35 percent) having intermediate or high-grade NHL.
  • Of the 42 evaluable patients, 31 (74 percent) were progression-free after a median follow-up of 1.5 years.
  • The combination regimen of high-dose Bexxar (iodine I 131 tositumomab) with high-dose chemotherapy was used to ablate the patients' bone marrow prior to transplantation in an effort to eradicate residual tumor cells in the body.
  • The study aimed to define the maximally tolerated dose of high-dose Bexxar in combination with high-dose chemotherapy and to define the response rates and toxicities associated with this regimen.
  • Dr. Oliver Press, M.D., Ph.D., professor of Medicine in the Division of Medical Oncology at the University of Washington Medical Center and member of the Fred Hutchinson Cancer Research Center, presented the data at the 34th Annual ASCO meeting.
  • The company believes that utilizing Bexxar in combination with chemotherapy and stem cell transplantation may increase the efficacy and safety profile of transplantation compared to conventional preparation with total body irradiation and chemotherapy.
  • Dr. Press also evaluated high-dose Bexxar as a single agent in conjunction with bone marrow transplantation, with 14 out of 29 patients (48 percent) remaining in remission for up to 8.5 years following Bexxar/bone marrow transplant treatment.

Statistics:

  • 270,000 people are afflicted with NHL in the United States alone (National Cancer Institute)
  • Approximately 140,000 people have low-grade or transformed low-grade disease
  • There are approximately 54,000 new cases of NHL diagnosed each year
  • 28 (65 percent) of the enrolled patients had low-grade NHL, and 15 (35 percent) had intermediate or high-grade NHL
  • 31 (74 percent) of the evaluable patients were progression-free after a median follow-up of 1.5 years
  • 14 out of 29 patients (48 percent) remained in remission for up to 8.5 years following Bexxar/bone marrow transplant treatment

Sources:

  • Data Presented at American Society of Clinical Oncology (ASCO)
  • Coulter Pharmaceutical (NASDAQ: CLTR)
  • BusinessWire press release, May 18, 1998
  • National Cancer Institute (NCL)
  • University of Washington Medical Center
  • Fred Hutchinson Cancer Research Center

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