More than fifty abstracts on Novartis' investigational leukemia agent Glivec™ (STI571) presented at Am. Soc. of Hematology

04-Dec-2000

Novartis Oncology today announced that data on Glivec™, formerly STI571, will be featured in more than 50 abstracts this week at the annual meeting of The American Society of hematology (ASH) in San Francisco. Glivec is an investigational treatment for certain forms of leukemia. The data offer new and updated information regarding the agent's potential activity in treating certain forms of leukemia that are characterized by the presence of the Philadelphia chromosome, including chronic myeloid leukemia (CML) and, to a lesser extent, acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML).

"We are extremely encouraged by the growing body of scientific evidence on our investigational agent Glivec, and its potential role in treating certain forms of CML," said David Epstein, President, Novartis Oncology. "Novartis is committed to the ongoing study of Glivec as a vital treatment option for physicians and patients in the battle against this disease."

Clinical Data Data will be presented from the largest multicenter Phase II studies ever conducted in CML to date, including the effectiveness of Glivec in patients with each phase of CML (chronic phase, accelerated phase and blast crisis) and each phase of Philadelphia chromosome-positive acute lymphoblastic leukemia.

Chronic Phase Study A Phase II Study of STI571, A Tyrosine Kinase Inhibitor, in Patients with Resistant or Refractory Philadelphia Chromosome-Positive Chronic Myeloid Leukemia: Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Resta D, Capdeville R, Druker B.

This Phase II, open-label study evaluated STI571 in patients with Philadelphia chromosome-positive (Ph+) CML in whom interferon had failed. Of the 532 patients enrolled, preliminary bone marrow cytogenetic results are available for 388 patients at three months. The findings demonstrated an overall cytogenetic response rate of 37%. Of the responses, 13% were complete (0 Ph+ cells) and 23% were major (<35% Ph+ cells). In 290 patients who had completed six months of therapy at the time of the analysis, preliminary data suggest an overall response rate of 56%. Hematologic results, not currently available, will also be presented at the meeting.

Accelerated Phase Study A Phase II Study of STI571 in Adult Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Accelerated Phase: Talpaz M, Silver RT, Druker B, Paquette R, Goldman JM, Reese SF, Capdeville R

This Phase II study includes 234 patients with CML in the accelerated phase. The preliminary response data, as assessed by the investigators, includes 154 patients who have been treated with STI571 for at least 4 weeks. The overall hematological response rate at 4 weeks is 78%, including 22 patients who have achieved a complete response.

Blast Crisis Phase Study A Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis: Sawyers C, Hochhaus A, Feldman E, Goldman JM, Miller C, Ben-Am M, Capdeville R, Druker B.

This Phase II, open-label trial includes 262 CML patients in the blast crisis phase. Preliminary data is based on 94 patients, 44 of whom received prior treatment for blast crisis and 50 of whom were untreated. In the previously untreated patients, the overall response rates were 48% and 47% at 4 and 8 weeks of therapy with STI571, respectively. In those who had received prior therapy for blast crisis, the response rates were 38% and 33%, respectively.

"We are pleased with the results we've seen with Glivec thus far. It represents a new approach to cancer therapy by targeting the specific biochemical abnormality associated with certain types of CML and other rare forms of leukemia," said David Parkinson, MD, Vice President, Clinical Research, Novartis Oncology.

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