FINALIST: Advancements in Health Care

Douglas J. Schwartzentruber, M.D.

System Medical Director of Indiana University Health Cancer Services; Associate Director of Clinical Affairs at IU Simon Cancer Center

A therapeutic vaccine for advanced melanoma patients combined with an immune-boosting drug scored promising results in a large clinical trial published in the New England Journal of Medicine last June 2. Researchers saw tumors shrink significantly and stay progression-free longer with the vaccine and interleukin-2, than with the drug alone.
 

(IBJ Photo/ Perry Reichanadter)

Douglas J. Schwartzentruber, M.D., lead author of the study, now serves as system medical director of IU Health Cancer Services. “This is proof of principle that vaccines can work to treat metastatic melanoma. The trial was one of the first of its kind, and the first to show a benefit of a peptide vaccine,” said Schwartzentruber, 55. A peptide is a small portion of a protein that is present on the surface of melanoma cancer cells.

Most vaccines are preventative. This melanoma vaccine is therapeutic, meant to boost the immune system enough to battle existing tumors.

The randomized Phase 3 clinical trial included 185 patients with metastatic melanoma at 21 care centers throughout the country. One group received the vaccine, along with interleukin-2, a drug that empowers the immune system. A second group only received interleukin-2.

Patients who received both the melanoma vaccine and drug did better than those who only got interleukin-2. Researchers saw tumors shrink 50 percent or more in 16 percent of the study population who received the vaccine and drug, compared to six percent with just interleukin-2.

Tumors grew slower when patients received the vaccine and drug. With the combination, tumors stopped growing for 2.2 months compared to 1.6 months with just interleukin-2. While the study was not designed to track survival rates, the median overall survival rate for those receiving the vaccine was 17.8 months versus 11.1 months. 

Before the trial, Schwartzentruber spent 16 years at the National Cancer Institute, the largest institute of the National Institutes of Health. He started as a fellow then moved up to senior investigator in the surgery branch, which studied melanoma.

Steven A. Rosenberg, M.D., PhD, surgery branch chief of the NCI, “taught me the research method and appreciation for melanoma. He’s the reason I pursued melanoma as a career. He also taught me how to deliver bad news to patients in a compassionate way,” Schwartzentruber said.

CA: A Cancer Journal for Clinicians recently reported a significant decline in overall cancer deaths in the last 20 years, but melanoma incidence and deaths have increased, and are expected to rise. Schwartzentruber’s research opens the door for vaccine treatments not only for melanoma, but other cancers as well.

His groundbreaking results were first presented during the American Society of Clinical Oncology conference in 2009, earning him recognition in 2010 on Time magazine’s annual list of the 100 most influential people in the world. 

Time hosted a red carpet affair in New York City that Schwartzentruber and his wife of 25 years, Diane White, attended. The magazine divides its “most influential” list into four categories: leaders, artists, thinkers and heroes. Time recognized Schwartzentruber in the thinkers category.

What’s next? The vaccine isn’t ready yet. It will be improved, there will be further study, and eventually it will go to market, Schwartzentruber said.