Both industry and clinical sources agree that cancer vaccine research—despite numerous stumbles in the past 15 years—is finally on the right track to achieve major advances in treatment. As one senior CEO of a company hoping to launch a new vaccine within the next several years said: “We’re beginning to figure out how to do this.”
That optimistic assessment is echoed by other clinical researchers and market analysts. For example, GlobalData, an international industry analysis specialist that tracks pharmaceutical development, confidently proclaimed: “The present pipeline for cancer vaccines seems to be very promising, with numerous molecules present in the phase II and III stages. From the market perspective, there are going to be multiple launches of vaccines between 2010 and 2013-14, which would substantially increase the market size and growth.”
This bright outlook is shared by one of America’s foremost researchers in cancer immunotherapy, James P. Allison, PhD, director of the Ludwig Center for Cancer Immunotherapy at Memorial Sloan-Kettering Cancer Center in New York City.
Table: Promising Cancer Vaccines in Advanced Clinical Trials
“The story is encouraging,” said Allison of the variety of vaccine formulations being investigated. (See “Types of Cancer Vaccines Being Investigated.”) Allison is one of the discoverers of the role that T cells and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) play in spurring the human immune system to attack cancer cells.
Because of this renewed optimism, the cancer vaccine industry appears to be going full speed in trying to find effective treatments. An estimated 130 potential cancer vaccines are now being studied, many in advanced clinical trials (Table)
, according to analysts.
But that optimism is tempered by past failures of once high-flying investigational cancer vaccines and by the steep cost of the few cancer vaccines that have recently been approved and entered the market.
Researchers and investors have been encouraged by the recent FDA approval of 2 vaccines: sipuleucel-T (Provenge), for the treatment of prostate cancer, and ipilimumab (Yervoy), for the treatment of metastatic melanoma. Provenge, which is manufactured by Dendreon, a company based in Seattle, Washington, was approved in April 2010 and uses a patient’s dendritic cells and cultures them with genetically engineered antigens. Yervoy was approved in March 2011 and is a human monoclonal antibody manufactured by Bristol-Myers Squibb. Allison, at Memorial Sloan-Kettering, was one of the founders of the cellular process on which ipilimumab is based.
Robert L. Kirkman, MD
Robert L. Kirkman, MD, president and CEO of Oncothyreon, which is based in Seattle, said that the START (Stimulating Targeted Antigenic Responses To NSCLC) study is a multicenter, randomized, double-blind, placebo-controlled trial that is evaluating patients with documented, unresectable stage IIIA or IIIB NSCLC. The START study will involve more than 1300 patients in some 30 countries.
At the same time, the companies are sponsoring the Stimuvax INSPIRE (In Asian Patients: Stimulating Immune Response) trial, also a phase III study testing the vaccine in Asian patients with advanced NSCLC. The trial is enrolling approximately 420 patients in China, Hong Kong, South Korea, Singapore, and Taiwan. INSPIRE is similar in design to START and will evaluate the efficacy, safety, and tolerability of Stimuvax in patients with unresectable stage III NSCLC. The primary endpoint is overall patient survival.
The START study is “pretty far along,” said Kirkman. He said the company was encouraged by the “very strong data from the phase II study,” which “showed a very significant 17-month improvement in median survival.” The 3-year survival data from the study, presented in 2007 at the International Association for the Study of Lung Cancer Congress in Seoul, South Korea, showed that patients given Stimuvax had a median survival of 30.6 months, compared to 13.3 months in patients not exposed to the vaccine.