Antigenics' Drug Study Leaves Questions
Posted on: Friday, 24 March 2006, 18:00 CST
Antigenics said Friday its phase 3 study of kidney-cancer drug Oncophage yielded conflicting results and more work is needed.
The company said that, in the study of 728 patients at high risk of cancer recurrence after surgery, the data showed a trend in favor of Oncophage for recurrence-free survival -- which was the study's primary endpoint -- but a trend against the potential treatment with the study's secondary endpoint, overall survival.
However, neither finding was statistically significant, the company said.
Researchers conducting the study looked at the number of cases of cancer recurrence or death, but Antigenics said an independent review by the trial's clinical events committee showed a substantially smaller number of events had actually occurred.
Antigenics said it remains unclear why the data showed conflicting results for the recurrence-free survival endpoint vs. the overall survival endpoint, adding there is no readily apparent adverse safety signal associated with the vaccine that the company believes could be contributing to this finding.
The company said it would meet with the Food and Drug Administration at the end of April to discuss the results and would work with study investigators to publish the data in a peer-reviewed medical journal.
We believe that further work is necessary to properly interpret these results, said Garo H. Armen, chairman and chief executive officer of Antigenics.
Upon completion of full analysis of the data, we will further refine our Oncophage strategy, which includes testing Oncophage in combination with other agents, and development of a higher-activity Oncophage. We will move expeditiously and in a fiscally responsible manner to complete this process in the coming weeks, he said.
Source: United Press International
Related Articles
- Time Between Treatment And PSA Recurrence Predicts Death From Prostate Cancer
- Research Shows Cancer Vaccines Led To Long-term Survival For Patients With Metastatic Melanoma
- Study Shows Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma and to Long Periods of Disease Control After Completion of Therapy
- Peregrine Pharmaceuticals Presents Promising Data From Its Phase II Bavituximab Breast Cancer Trial at 2009 ASCO Annual Meeting
- Study Published in New England Journal of Medicine Shows ERBITUX(R) Improved Survival in First-Line Recurrent And/Or Metastatic Head and Neck Cancer
- Phase II Results For Yale's Early Stage Ovarian Cancer Blood Test 99% Accurate
- OSI Pharmaceuticals Announces Pivotal Phase III Tarceva(R) Study Published in the Journal of Clinical Oncology Showed Survival Improvement in Patients With Pancreatic Cancer
- Threshold Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating Glufosfamide in Patients With Recurrent, Sensitive Small Cell Lung Cancer
- 'Real Life' Study Clarifies Risk of Recurrence for High-Risk Breast Cancer Patients
- ADVENTRX Reports Positive Preliminary Phase II Trial Results With CoFactor in Metastatic Colorectal Cancer; Data Show Increased Response Rate and No Grade 3/4 Gastrointestinal or Hematological Toxicity
 |
 |
User Comments (0)
RSS Feeds