Oncophage
From Kidney Cancer Resource
Contents |
Overview
Oncophage® (vitespen; formerly HSPPC-96) is an investigational patient-specific vaccine designed to treat cancer with the intent of minimizing side effects. Currently being evaluated in clinical trials, treatment with Oncophage is designed to target only cancerous cells — not healthy normal cells. As a result, Oncophage is designed to limit the toxicities associated with traditional broad-acting cancer treatments.
Oncophage has been granted fast track and orphan drug designations from the US Food and Drug Administration for kidney cancer and metastatic melanoma.
Has been trialed for patients with nonmetastatic renal cell carcinoma (RCC).
Details
-- In May 2007, at the Annual Meeting of the American Urological Association, Antigenics presented updated results based on its continued data collection from the Phase 3 trial of Oncophage (C-100-12) in patients with nonmetastatic renal cell carcinoma (RCC). These updated results showed that the advantage in the Oncophage arm persisted or improved in comparison with the first analysis of the data. In summary, there was an improvement in recurrence-free survival in the Oncophage arm versus the observation arm of approximately 45 percent (P less than 0.01; hazard ratio = 0.55) in the intermediate-risk patient population (n = 362). A trend toward improved overall survival (not statistically significant) was also observed in the intermediate-risk subset.
-- In the second half of 2007, Antigenics met with urology and oncology key opinion leaders from Europe, Russia, Canada and the United States to discuss the updated results from the C-100-12 RCC trial. Overall, the feedback received was very positive, and has encouraged the company to explore regulatory pathways for potential filings of marketing applications in ex-US territories.
-- In June 2007, a marketing authorization application for Oncophage in the intermediate-risk patient population was filed in Russia, where review of the application continues.
-- Pre-launch activities are ongoing to prepare for potential commercialization of Oncophage in Russia in mid-2008.
-- A meeting with the European Medicines Agency (EMEA) is scheduled for the first quarter of 2008. Antigenics plans to discuss with the EMEA the potential filing of a marketing authorization application for conditional authorization of Oncophage.
-- Antigenics has initiated a survival registry to follow approximately 500 patients from the Phase 3 kidney cancer study. Initial data are expected by the end of 2008.
-- Results from a Phase 3 study of Oncophage in metastatic melanoma were recently published in the Journal of Clinical Oncology. The published data showed that patients receiving at least 10 doses of Oncophage had improved median survival of approximately 18.4 months versus patients who received physician's choice of treatment.
-- A white paper written by a group of prominent oncologists, including investigators from Antigenics' Phase 3 study in kidney cancer and regulatory experts, was recently published in Cancer (Stebbing et al. Cancer. 2008 Jan 18. (Epub ahead of print)). The paper proposes three regulatory mechanisms for accelerated development and approval of therapeutic cancer vaccines in earlier stages of disease.
-- A Phase 2 investigator-sponsored study of Oncophage in recurrent glioma being conducted at the University of California, San Francisco is ongoing. Updated data from the Phase 1 study showed that 11 out of 12 patients exceeded the historical benchmark of 6.5 months of survival from time of recurrence. The Phase 1 study also showed that all 12 treated patients demonstrated a significant and specific immune response after vaccination with Oncophage (P less than 0.001).
QS-21 Stimulon(R) Adjuvant
-- Significant progress was made in 2007 by Antigenics' QS-21 licensees in the development of vaccines containing QS-21. There are now 16 QS-21-containing vaccines in clinical development - two in Phase 3, 10 in Phase 2, and four in Phase 1. Antigenics' QS-21 licensees include GlaxoSmithKline (GSK), Elan and Acambis.
-- Acambis recently announced the results of a Phase 1 study of its ACAM-FLU-A(TM) influenza vaccine, which contains QS-21. The greatest immune response was seen in the ACAM-FLU-A plus QS-21 adjuvant arm, in which 90 percent of subjects generated virus-specific antibodies following immunization. Based on these results, Acambis exercised its option for a commercial license for QS-21.
-- Other significant advancements in 2007 included the initiation of a Phase 3 trial of GSK's MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in non-small cell lung cancer and the initiation of the Phase 2 study of Elan's Alzheimer's disease vaccine.
-- A recent publication in Vaccine (Vandepapaliere et al. Vaccine. 2008 Jan 14. (Epub ahead of print)) described a randomized, placebo-controlled clinical study that compared four adjuvant systems, three of which contained QS-21, in combination with recombinant hepatitis B surface antigen. High levels of antibodies were induced by all four adjuvant systems, while the strongest cellular immune responses were observed in the three adjuvant systems containing QS-21.
Phase 1 Programs
-- Phase 1 trials are ongoing for Aroplatin, in solid tumors and B cell lymphomas, and AG-707, in genital herpes.
-- Immunology data is expected from the AG-707 study in the first half of 2008. The results will guide the company's future development and/or partnering strategy for the program.
Articles
The Lancet (KC) 04-Jul-08
- Kidney cancer vaccine Vitespen falls short in clinical trial: study
Cancer Consultants (KC) 09-Apr-08
- Oncophage® Vaccine May Have Activity in Renal Cell Carcinoma....
Doctor's Guide (KC) 08-Apr-08
- Cancer Vaccine Approved in Russia for Patients With Intermediate-Risk Renal Cell Carcinoma....
The News and Observer (KC) 22-Feb-08
- Antigenics Reports Fourth Quarter and Year-End 2007 Financial Results....
References
Disclaimer
Kidney Cancer Resource (KCR) is not influenced by sponsors. The information contained herein is not intended as a substitute for the advice of an appropriately qualified and licensed physician or other licensed health care provider. The information provided here is for educational and information purposes only. Early accurate Diagnosis (Dx.) saves lives. Please check with a physician if you suspect you are ill, never ignore Symptoms. To help your health care specialist make an accurate Diagnosis please keep notes of dates, times and details of your Symptoms. We are not offering medical advice nor do we consider links, individuals or articles accessed through this site to be offering medical advice.
E&OE - Errors & Omissions Excepted
As much of the information posted on this Web Site for peoples convenience is of a medical or technical nature, and may be a matter of life or death the E&OE is a Disclaimer showing that to the best of our ability information is accurate and correctly written or transcribed. Before acting on information on this site you are responsible for checking it with your relevant medical team. We can not be held responsible for any Errors & Omissions made; nor for information on links and articles provided in good faith.
