Independent Monitoring Board Recommends Completion of Accrual to Genasense(R) Phase 3 AGENDA Trial in Advanced Melanoma
September 15 2008 - 8:05AM
PR Newswire (US)
BERKELEY HEIGHTS, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Genta
Incorporated (OTC:GNTA) (BULLETIN BOARD: GNTA) announced today that
the independent Data Monitoring Board (DMB) for AGENDA, a Phase 3
trial of the Company's lead oncology product Genasense(R)
(oblimersen sodium) Injection, has completed its review. During its
review, the DMB evaluated safety data from the study and conducted
an analysis for futility. With more than half of the initially
planned number of patients now enrolled, the Board recommended that
the trial continue to completion of full enrollment. AGENDA is a
Phase 3, randomized, double-blind, placebo-controlled trial that is
intended to support global registration of Genasense for patients
with advanced melanoma. The study is designed to confirm certain
safety and efficacy results from Genta's prior randomized trial of
Genasense combined with dacarbazine (DTIC) in patients identified
by a biomarker who have not previously received chemotherapy. The
co-primary endpoints of AGENDA are progression-free survival and
overall survival. A total of 300 patients are expected to enroll in
AGENDA. Genta will provide a pooled update of blinded data from
AGENDA, compared with data obtained in this biomarker-defined
population from the Company's previous Phase 3 trial (see below),
at an international scientific meeting, Perspectives in Melanoma
XII, that is scheduled for October 2-4, 2008. "We remain quite
pleased with the high investigator enthusiasm for AGENDA," said Dr.
Loretta M. Itri, M.D., Genta's President, Pharmaceutical
Development. "We currently anticipate that accrual will complete in
the first quarter of 2009." About AGENDA AGENDA employs a biomarker
to define those patients who derived maximum clinical benefit
during a large randomized study of DTIC with or without Genasense,
known as study GM301. These patients are characterized by
low-normal levels of LDH (lactate dehydrogenase), a tumor-derived
enzyme that is readily detected in blood. Analysis of the previous
efficacy outcomes observed in 274 patients from GM301, which AGENDA
is designed to confirm, yielded the following results: Hazard
Endpoint Genasense/DTIC DTIC Ratio P Overall response 20.8 % 7.2 %
0.002 Durable response 10.7 % 2.4 % 0.007 Progression-free
survival, median 3.6 mos. 1.6 mos. 0.58