Source: Arthroscopy  |  Posted 5 years ago

Patients with CT-Confirmation Achieve Significantly Longer Remission Duration

BERKELEY HEIGHTS, NJ -- December 14, 2006 -- Genta Incorporated announced the presentation of data that review the impact of computed tomographic (CT) scans in clinical trials of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

The analyses derive from the Company's pivotal Phase 3 trial of chemotherapy with or without Genasense(R) (oblimersen sodium) Injection, the Company's lead anticancer drug. Results show that CT scanning is a prevalent standard of care, and that absence of CT overestimates complete remission rates in clinical trials by approximately 30%. In contrast, patients in whom complete remission has been documented by a negative CT have significantly longer remission duration and a trend toward longer time-off chemotherapy. The data were presented Monday at the annual meeting of the American Society of Hematology (ASH) in Orlando, FL.

In this multinational randomized trial, 241 relapsed or refractory CLL patients were randomly assigned to receive fludarabine and cyclophosphamide (Flu/Cy) with or without Genasense. Eighty percent of patients had a baseline CT or ultrasound, and 75% of these tests showed occult disease. Standard response criteria do not currently mandate CT to confirm response. However, by agreement with FDA, the Genasense registration trial required that patients with CT abnormalities at baseline show resolution of disease by CT (or ultrasound) in order to be declared in complete or nodular partial remission (CR/nPR). In order to assess the impact of this test, this analysis assumed that the required bone marrow evaluation would have shown CR/nPR in patients who achieved response by all other clinical criteria.

Thus, the incidence of CR/nPR was assessed with CT, without CT, and without CT in patients who were prospectively stratified as being "non refractory" to chemotherapy.

The incidence of CR/nPR would have been overestimated by approximately 30% absent the use of CT. These data accord with recent results in previously untreated CLL patients from cooperative groups in Spain and Germany.

"These data indicate that CT scanning is already a prevailing standard of care for patients with CLL," commented Peter Maslak, M.D., Chief, Hematology Laboratory Service, and Attending Physician, Leukemia Service, Memorial Sloan-Kettering Cancer Center. "These results in relapsed/refractory patients are strikingly similar to results obtained from other groups in previously untreated patients. Collectively, these data indicate that prior studies have routinely overestimated the incidence of "complete" remission by ignoring abdominal disease that can be readily assessed. Going forward, we believe that CT data should be routinely incorporated into the evaluation and comparison of therapeutic trial results."

About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

SOURCE: Genta Incorporated