Genta Incorporated (OTCBB: GETA) announced today the presentation of combined data on early endpoints from the Company’s randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma. The presentation included a “pooled analysis” that assessed combined efficacy results for the endpoints of overall response and progression-free survival from both studies. The data were presented today at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.
“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”
Genta has conducted two Phase 3 randomized controlled trials of chemotherapy with dacarbazine (DTIC) with or without Genasense, known as GM301 and AGENDA, which comprised a total of 1,085 patients. AGENDA was designed 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). However, AGENDA was powered to detect differences in overall survival, and the late endpoints of overall survival and durable response are currently being collected in blinded followup.
The statistical analysis plan for AGENDA prospectively specified a “pooled analysis” that combined final results for overall survival from both studies. Today’s presentation featured exploratory analyses using combined data on the early endpoints that are currently available, using both the intent-to-treat (ITT) populations (i.e., all patients in both studies), as well as the patients with low-normal LDH from GM301, as presented in the tables below.
“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. “The pooled analysis of data from more than 1,000 patients supports observations from the individual trials that the addition of Genasense to DTIC is associated with an increase in overall response and improvement in progression-free survival. However, unlike survival and durable response, these early endpoints are not established for regulatory purposes as demonstrating clinical benefit in this population. We expect to complete the blinded followup for overall survival and durable response from AGENDA in the first quarter of 2011, and we look forward to those results.”
SOURCE Genta Incorporated