When Denny Terry first came under the care of medical oncologist Oliver Sartor, MD, 17 years ago, he knew immediately this was a physician and a scientist with a quest to keep him and others like him alive. “He’s brilliant and he cares,” says Denny, a mechanical engineer and small business owner from Jackson, Mississippi. “I saw that right away. Cancer cells have but one aim, to keep themselves alive, which too often means killing their host, and that’s me,” says Denny. “Over the years, Oliver has always had something in his back pocket to encourage me, and when he mentioned this clinical trial [of Xofigo] I jumped at it. This drug is designed to kill tumors. I said let’s go!”
Denny was the second man in the U.S. to receive Xofigo through an expanded access program following the ALSYMPCA study, a Phase III randomized, double-blind, multinational study of men with treatment-resistant prostate cancer (TRPC) that has spread to bone. Bone metastasis is a major cause of death in men with metastatic TRPC; more than 90 percent of men at this disease stage have bone metastases. Aside from robbing men of life, prostate cancer that spreads to bone can cause severe pain and disability, and even paralysis if tumors compress the spinal cord. Xofigo is a first-in- class injectable radiopharmaceutical; it naturally homes in to bone, especially areas of bone invaded by cancer cells. Once at the microenvironment of the bony tumor site, the drug emits tiny radioactive alpha particles that blast tumors apart. Because the effect of the drug is limited to a 10-cell radius, healthy tissue is spared and toxicity and side effects to the patient are minimal.
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Men enrolled in the ALSYMPCA trial received either the current best standard of care along with injections of Xofigo or the best standard of care and placebo injections. (At the time of the study, Xofigo was known as either Alpharadin or Radium-223. Best standard of care was liberally defined for this study, and men might have received a variety of hormone therapies, but none received chemotherapy concurrently with Radium-223.) Ultimately the study was stopped early as the benefits of receiving the drug over a placebo became apparent and all men were offered the drug. As explained in the New England Journal of Medicine, Xofigo both extended men’s lives and enhanced their quality of life, delaying the onset of complications resulting from bone cancer such as fractures and spinal cord compression. Xofigo won FDA approval for men with bone-metastatic TRPC on the basis of Phase III ALSYMPCA results.
“Through the ALYSMPCA trial, it became quite apparent to me that patients not only were living longer, they were living better,” says Sartor, who has been researching bone- targeted radiopharmaceuticals for over 20 years. Early on, he recognized the possibilities of using alpha particles to target tumors. His work on the clinical trials is recognized as central to the drug’s success.
Denny, who has metastatic disease “up and down” his spine, says he “sailed through the six months” he was on Xofigo. “As much disease as I have today, I’m without pain,” he says. “Nineteen years ago, when my doctor told me I had a tumor that ‘hit me right between the eyes,’ I knew, as we like to say in the South, it would be a ‘tough row to hoe.’ I’d never have thought with a PSA as sky-high as mine is today that I’d be anywhere but on my deathbed.” Instead, Denny works daily, travels to his Florida beach home, is active in a Christian charity he founded with his beloved wife, and spends time with his three children, one of whom has Down syndrome, and three grandchildren.