Genta, Inc (fka GNTAQ)

[chrisboker]

I think we all need to take a step back to 2006 when we conducted the largest trial ever that related to advanced melanoma. The endpoints were different the reason this was not approved after these results is because the FDA wanted more data.

BERKELEY HEIGHTS, NJ – September 15, 2006 – Genta Incorporated (NASDAQ:
GNTA) announced that results of the Company’s Phase 3 trial of Genasense® (oblimersen
sodium) Injection in patients with advanced melanoma were published on-line this week in
the Journal of Clinical Oncology, ahead of its print publication date of October 10, 2006.
The paper is accompanied by an editorial that discusses the trial’s results in the context of
current options for melanoma treatment. The extended follow-up data from this
publication form the basis of a Marketing Authorization Application (MAA) that is
currently pending review by the European Medicines Agency (EMEA).
“In our paper, long-term followup has confirmed the trends that were observed in the
earlier analyses”, said Dr. Agop Y. Bedikian, Professor of Medicine at M.D. Anderson
Cancer Center, Houston, TX, who is the lead author on the paper. “This was the first trial
to achieve such a broad array of positive endpoints. I believe the aggregate data indicate
that Genasense can be a major addition to chemotherapy for patients with this disease, with
a side-effect profile that is highly manageable.” The article can be accessed on-line at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
Genasense, Genta’s lead anticancer drug, is a novel targeted therapy that blocks the
production of Bcl-2, a protein that appears to be a fundamental cause of resistance to
cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the
effectiveness of chemotherapy in patients with advanced melanoma. A summary of the
data from the final analysis appears below.
Efficacy Data
The report is based on long-term data derived from the largest randomized controlled trial
that has ever been conducted in patients with advanced melanoma. In this trial, which was
conducted at 139 sites in 9 countries, 771 patients were randomly assigned to receive
chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The
paper includes data from a prospectively defined analysis that evaluated 24-months of
minimum follow-up on all patients. Unless otherwise noted, these results were based on
an intent-to-treat analysis:
Endpoint Genasense/DTIC DTIC P
Overall response 13.5% 7.5% 0.007
Complete response 2.8% 0.8% 0.03
Durable response 7.3% 3.6% 0.03
Progression-free survival, median 2.6 mos. 1.6 mos. 0.0007
Overall survival, median 9.0 mos. 7.8 mos. 0.077
Prior to randomization, patients were prospectively stratified according to certain risk
factors, including elevated blood levels of an enzyme known as LDH – a factor that
previous clinical studies have shown is strongly associated with poor outcome. The final
analysis has shown that LDH was the sole stratification factor significantly associated with
a treatment interaction. When this treatment effect was evaluated, the efficacy of
Genasense was significantly superior for all major efficacy outcomes in patients who had
normal LDH at baseline, a group that comprised approximately two-thirds of patients in
the trial (N=508). In this group, the following efficacy results were observed:
Endpoint Genasense/DTIC DTIC P
Overall response 17.2% 9.3% 0.009
Complete response 3.4% 0.8% 0.04
Durable response 9.6% 4.0% 0.014
Progression-free survival, median 3.1 mos. 1.6 mos. 0.0007
Overall survival, median 11.4 mos. 9.7 mos. 0.018
Safety Data
The most frequent serious adverse events that occurred in ≥ 5% of patients were fever and
disease progression (6.2% vs. 2.8%, and 5.1% vs. 4.7%, respectively, for Genasense/DTIC
compared with DTIC alone). The most frequent Grade 3 or 4 adverse events that occurred
in ≥ 5% of patients were neutropenia (21.3% vs. 12.5%), thrombocytopenia (15.9% vs.
6.4%), leukopenia (7.5% vs. 3.9%), anemia (7.3% vs. 4.7%), and nausea (6.7% vs. 2.5%).
Although there was an increase in discontinuations due to adverse events in the Genasense
arm (19% vs. 11%), there was no difference in the number of fatal, treatment-emergent
adverse events