GlaxoSmithKline Announces Phase III Trial of Lung Cancer Vaccine
NEW YORK, NY – June 4, 2006 – GlaxoSmithKline (GSK) announced today that preliminary interim results from a phase II clinical trial show that a new cancer vaccine against the most common type of lung cancer appears to reduce the risk of recurrence after surgery by 30 percent compared to placebo. “We are very encouraged by these results,” stated Vincent Brichard, M.D., Ph.D., director of the Clinical Development Cancer Program at GSK Biologicals, “as they validate years of research…into the ways to harness the immune system against cancer.” GSK announced the results of its non-small cell lung cancer trial at the 2006 American Society for Clinical Oncology meeting in Atlanta, Georgia.
Larger studies of the cancer vaccine will begin early in 2007, the company said. The vaccine targets tumors bearing MAGE-A3, a protein marker, or antigen, found in approximately 35 to 50 percent of early stage non-small cell lung cancer (NSCLC). This type of lung cancer is the number one cause of cancer deaths in the United States in both men and women.
The MAGE-A3 antigen was first discovered by scientists from the Ludwig Institute for Cancer Research (LICR), CRI's partner in the Cancer Vaccine Collaborative (CVC). The CVC sponsored one of the first early-phase clinical investigations of the MAGE-A3 cancer vaccine at the Weill Medical College of Cornell University in New York City under principle investigator Nasser K. Altorki, M.D. “The magnitude of reduction in lung cancer recurrence in the GSK vaccine trial is within the range expected after chemotherapy given following surgery for this type of lung cancer,” said Dr. Altorki. “Within that context, I'd say this is potentially a significant and important advance for cancer vaccine research and for lung cancer patients.”
Following news of the clinical trial's success, GSK also announced today that it has licensed a substantial portfolio of tumor-specific antigens, including MAGE-A3 and NY-ESO-1, from the Ludwig Institute. These antigens will be used in combination with GSK's proprietary immune-stimulating adjuvant in vaccines against other types of cancer, including melanoma, breast, head and neck, bladder, and liver cancers. According to CRI Executive Director Jill O'Donnell-Tormey, Ph.D., CRI views the GSK-LICR deal as a major step forward for cancer vaccine research, and heralds an increasing interest on the part of private industry in the cancer immunology's promise. “Industry is catching up with science, finally.” Both CRI and LICR, she stated, are keenly interested in how the antigen-specific therapies will perform in the larger clinical studies.
“This is precisely how we envisioned the Cancer Vaccine Collaborative would work when we established it in 2001,” stated Dr. O'Donnell-Tormey. “Our coordinated network of academic research institutions fills a long-neglected but essential niche in the discovery process. Through the CVC, CRI is capable of conducting scientifically rigorous early-stage clinical investigations that are teaching us the fundamentals of cancer vaccination.” CVC trials test multiple, single-variable vaccination strategies simultaneously at major academic research centers around the world. These studies have produced valuable information about the immune-stimulating capabilities of MAGE-A3 and other cancer-specific antigens.
“Given the very high cost of broad-scale, late-phase clinical studies, the hope is that results from the CVC trials will interest pharmaceutical companies like GSK in carrying forward very expensive later-phase clinical studies,” said Dr. O'Donnell-Tormey.
The licensing arrangement between LICR and GSK is a good example of how academia and industry can work together symbiotically to bring these promising immunotherapies to the public.
“This is a bold step forward, but this is only the beginning and there is still much research to be done," Dr. O'Donnell-Tormey said. "CRI remains committed to realizing the enormous potential of cancer immunotherapy and we will continue to invest strategically in both laboratory and clinical research.”
Several ongoing Cancer Vaccine Collaborative trials are studying the viability of other known antigenic targets for vaccine therapy. “We will also continue to feed the CVC pipeline with new antigenic targets as they are identified by our scientists within the Cancer Antigen Discovery Collaborative,” Dr. O'Donnell-Tormey said. “Moreover, we will continue our carefully coordinated exploration of various immunization strategies until we find the most effective ways to vaccinate against cancer.”
UPDATE: In June of 2007, GSK announced that it would bring the MAGE-A3 vaccine into a phase III clinical trial, the largest trial of a lung cancer therapy ever conducted. Read the announcement from GSK here.
About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is the world’s only nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes three Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $282 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to www.cancerresearch.org