December 09, 2002
Genta (NASDAQ: GNTA) and Aventis’s (NYSE:
AVE) Genasense (oblimersen) has generated continued evidence of biological activity as monotherapy for patients with chronic myelogenous leukemia (CLL). Although these advance earlier phase I anecdotes, the agent’s true magnitude of therapeutic effect remains to be demonstrated. Data were presented today at the American Society of Hematology meetings.
Phase II data were presented on the first 23 study subjects. The results demonstrated that, for refractory CLL patients, Genasense administration was associated with:
- 2 partial responses (9%)
- 11 disease stabilizations (48%)
- 9 reductions in circulating CLL cells by more than 50% (39%)
- 8 reductions in lymph node size by more than 50% (42%)
- 8 (of 16 relevant patients) reductions of enlarged livers or spleens (50%).
Two other studies assessed Genasense as a treatment for acute myelogenous leukemia (AML). They supported preclinical evidence that Genasense can downregulate the Bcl-2 protein in specifically chomosomally-deranged (MLL) leukemic cells by approximately 60%. The study also demonstrated anecdotal phase I evidence of efficacy. 5 of the first 11 evaluable patients in a phase I trial, remarkable for a reassuring toxicity profile, have achieved complete remission. This dose-finding investigation, in combination with daunorubicin and cytosine arabinoside, is ongoing.
Genta and Aventis have not yet commented on the many other ongoing phase II and III trials. Physician interest at the meeting is suboptimal and lacks enthusiastic anticipation of those data.
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