Cancer Immunotherapy Trials Successful; Market To Explode

Two new studies find that drugs that use the body’s own immune system to help fight cancer are proving to be effective in many cases even as a report from London-based research and consulting firm GlobalData projects that the total immuno-oncology market will be worth approximately $14 billion by 2019, rising to $34 billion by 2024.

Promising trials for the two new immunotherapies — Ono/Bristol-Myers Squibb’s Opdivo for recurrent or metastatic squamous cell carcinoma of the head and neck and Schering Plough/Merck’s Keytruda for an extremely lethal skin cancer called Merkel cell carcinoma — “suggest the treatment approach is poised to become a critical part of the nation’s anti-cancer strategy,” Laurie McGinley reports for the Washington Post.

According the the GlobalData report, “the approval and uptake of immuno-oncology products is set to burgeon due to increased recognition of their long and durable tumor responses, which are similar to targeted therapies. Furthermore, these treatments have shown efficacy in a wide variety of indications and are not associated with the adverse side effects produced by traditional chemotherapy….”

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It projects that the two biggest sellers in the short term will be Opdivo, with about $10 billion in sales by 2024, and Keytruda with about $7 billion.

“Both therapies, which are programmed cell death protein-1 (PD-1) inhibitors, will achieve such impressive sales due to the fact that they will be first-to-market in many indications, transcending competition such as Roche’s atezolizumab and AstraZeneca’s durvalumab,” according to Dan Roberts, GlobalData’s senior analyst covering oncology and hematology. 

“Immuno-oncology products have demonstrated comparable respective efficacy and safety profiles, so their commercial success will largely rest on the speed with which they enter the market, their clinical and commercial positioning, target patient populations, and the marketing power of the relevant pharmaceutical company,” according to Roberts.

“We are in the midst of a sea change in how we are treating cancer,” Louis Weiner, director of the Georgetown Lombardi Comprehensive Cancer Center, who wasn’t involved in the studies, tells the Post’s McGinley. “We’re really seeing the fruits of many years of research into what drives cancer and how it interacts with the immune system to defeat it and survive.”

In a report from the annual meeting of the American Association for Cancer Research in New Orleans Sunday, the Wall Street Journal’s Ron Winslow wrote that 34% of 107 advanced melanoma patients treated in a study of Opdivo have survived at least five years.

“This is a new benchmark for melanoma,” said F. Stephen Hodi, director of the Melanoma Center at Dana-Farber Cancer Institute, Boston, and an investigator at Harvard Medical School’s Ludwig Center, in presenting the finding.

“Opdivo is one of three so-called checkpoint inhibitors currently on the market. Blocking the checkpoints releases molecular brakes, thus allowing immune system cells called T cells to attack cancer,” Winslow writes. Opdivo and Keytruda target a brake called PD-1, and both are approved for melanoma and for lung cancer, he reports. 

The trial for Keytruda was conducted in 26 patients, 14 of whom responded (56%) — 12 with ongoing response, reports Zosia Chustecka for Medscape

“The responses were rapid, and were either present or not,” according to principal investigator Paul Nghiem M.D., Ph.D., professor of medicine, division of dermatology, University of Washington School of Medicine, Seattle. “Even one or two doses of this drug have a profound and lasting effect. The balance of the immune system can be tweaked with a single dose.”

In December, former President Jimmy Carter announced that he was “cancer free” after taking Keytruda for his metastatic melanoma. Carter’s cancer was discovered in his liver and spread to his brain, Matthew Tontonoz reported for Memorial Sloan Kettering Cancer Center’s Web site. But Carter was also treated with surgery and radiation, and one MSKCC doctor interviewed said, “I don’t think it’s possible to ascribe the very favorable result to just one intervention.”

This week’s positive news comes as Vice President Joe Biden prepares for a trip to the Vatican at the end of the month to discuss his “moonshot” initiative to fight cancer at a conference on regenerative medicine organized by the Stem for Life Foundation and the Vatican's Pontifical Council for Culture, as Nick Gass reported for Politico last week.

And late last month, media magnate and former New York City mayor Michael Bloomberg and Sidney Kimmel, founder of Jones Apparel Group, agreed to donate $50 million each to create the Bloomberg–Kimmel Institute for Cancer Immunotherapy at the Sidney Kimmel Comprehensive Cancer Center in Baltimore, Johns Hopkins University announced. More than a dozen other donors contributed another $25 million.

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