ISIS / Affinitak
CARLSBAD, Calif. and INDIANAPOLIS, March 17 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS - News) and Eli Lilly and Company (NYSE: LLY - News) announced today results of a Phase III trial that evaluated the antisense agent Affinitak(TM) when combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).
No difference was observed in a primary log-rank analysis of the overall survival of the two groups (p=0.81). Survival was the primary endpoint of the study. Patients receiving Affinitak plus the chemotherapy regimen of carboplatin and paclitaxel experienced a median survival of 10 months, compared to 9.7 months for patients receiving chemotherapy alone. The median survival of the control group was longer than expected, in light of the fact that 87% of patients had Stage IV disease.
Other key findings from the trial of 616 chemotherapy naive patients with Stage IIIb or Stage IV NSCLC are as follows:
-- Using a stratified log-rank statistical analysis that considered
predefined variables, including duration of treatment, survival of the
Affinitak treated patients was greater than that of the patients in
the control arm. Based on all 616 patients in the study, this result
was statistically significant (p=0.048) and merits further evaluation.
-- A survival analysis of the 256 patients who completed the prescribed
course of chemotherapy showed a median survival of 17.4 months for
Affinitak patients versus 14.3 months for patients receiving
chemotherapy alone (p=0.054). The prescribed course of therapy was
6 cycles of treatment.
-- Additionally, in the 256 patients completing the prescribed course of
chemotherapy, results favored the Affinitak group across multiple
secondary endpoints.
-- Treatment groups in the trial were comparable with regard to all major
prognostic factors. For example, each group had approximately 87% of
patients with Stage IV disease and was comparable in terms of types of
lung cancer.
-- Addition of Affinitak to carboplatin and paclitaxel was well
tolerated. There were no increases in severe toxicities or toxicity
related deaths in patients receiving Affinitak, compared to those
receiving chemotherapy alone. The most common side effects among
patients in the study were fatigue and nausea. Patients in the study
receiving Affinitak in combination with chemotherapy had a higher rate
of moderate thrombocytopenia, nausea and vomiting. Further, because
Affinitak is given via continuous intravenous infusion, Affinitak
treated patients had a higher incidence of catheter-related
infections.
The complete findings of this trial will be submitted for scientific presentation at an appropriate medical meeting later this year.
"The observation that those patients who completed the prescribed course of therapy appeared to survive longer than patients receiving chemotherapy alone merits further evaluation," said Jon Holmlund, M.D., Isis' Vice President, Development.
"The partnership between Lilly and Isis and our commitment to further investigate the antisense platform in cancer is unchanged," said Paolo Paoletti, M.D., Vice President of Oncology Products, Eli Lilly and Company. "We expect to continue to study the utility of antisense technology in cancer clinical trials."
"While we are disappointed with the outcome of this trial, we plan to work closely with our partner, Lilly, to determine the future of this drug in non-small cell lung cancer," said Stanley Crooke, M.D., Ph.D., Isis' Chairman and CEO.
Isis and Lilly will conduct a live webcast conference call to review the Affinitak Phase III trial results on Monday, March 17 at 9:00 AM Eastern time. To participate over the Internet go to www.isispharm.com or firstcallevents.com A replay of the webcast will be available at this address for up to 30 days. |
