Genta Inc. (GETA.OB) Announces Combined Data of Early Endpoints from Phase 3 Trials of Genasense® in Advanced Melanoma

In the company’s news yesterday,

Genta Inc. announced the presentation of pooled results on early endpoints from their randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma. The Company presented the data yesterday at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.

The presentation included a “pooled analysis.” This analysis assessed combined efficacy results for the endpoints of overall response and progression-free survival from both studies. Yesterday’s presentation featured exploratory analyses using combined data on the early endpoints that are currently available, using both the intent-to-treat (ITT) populations (all patients in both studies), and the patients with low-normal LDH from GM301. The Company has conducted two Phase 3 randomized controlled trials of chemotherapy with dacarbazine (DTIC) with or without Genasense, known as GM301 and AGENDA. The trials comprised 1,085 patients.

The design of AGENDA was to confirm results from GM301 that showed increased survival in patients with low-normal baseline levels of a biomarker (lactate dehydrogenase [LDH]). Initial results did not show a statistically significant difference in early endpoints (overall response and progression-free survival). AGENDA’s focus, in fact, was to detect differences in overall survival. The late endpoints of overall survival and durable response are now being collected in blinded follow-up.

“In both trials, all efficacy endpoints were numerically superior in patients who received Genasense plus chemotherapy compared with patients who were treated with chemotherapy alone”, said Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer.

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