The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients. In July, an expert panel of the Food and Drug Administration recommended approval of a groundbreaking new leukemia treatment, a type of immunotherapy. Companies are scrambling to develop other drugs based on using the immune system itself to attack cancers. Many of these experimental candidates in trials are quite similar. Yet each drug company wants to have its own proprietary version, seeing a potential windfall if it receives F.D.A. approval.
As a result, there are more than 1,000 immunotherapy trials underway, and the number keeps growing. “It’s hard to imagine we can support more than 1,000 studies,” said Dr. Daniel Chen, a vice president at Genentech, a biotechnology company. In a commentary in the journal Nature, he and Ira Mellman, also a vice president at the company, wrote that the proliferating trials “have outstripped our progress in understanding the basic underlying science.”
“I think there is a lot of exuberant rush to market,” said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “And we are squandering our most precious resource — patients.” Take melanoma: There are more than 85,000 cases a year in the United States, according to Dr. Norman Sharpless, director of the Lineberger Comprehensive Cancer Center at the University of North Carolina, who was recently named director of the National Cancer Institute.
Most melanomas are cured by surgery, leaving about 10,000 patients who have had relapses and could be candidates for an experimental treatment. But nearly all will be treated by doctors outside of academic medical centers, who are not part of the clinical trials network and so do not offer patients experimental treatments. Companies therefore must compete for the few patients with relapsed melanoma who are at centers offering clinical trials.
Many end up struggling to find enough subjects to determine whether a treatment actually works — and if so, for whom. And these drugs often are not so different from one another. Immunotherapy drugs that attack a protein known as PD-1 are approved for treatment of lung cancer, renal cell cancer, bladder cancer and Hodgkin’s disease, noted Dr. Richard Pazdur, director of the F.D.A.’s Oncology Center of Excellence. Yet many pharmaceutical companies want their own anti-PD-1. Companies are hoping to combine immunotherapy drugs with other cancer drugs for added effect, and many do not want to have to rely on a competitor’s anti-PD-1 drug along with their own secondary drugs. So in new trials, additional anti-PD-1 drugs are being tested all over again against the same cancers — a me-too business strategy taken to multibillion-dollar extremes. “How many PD-1 antibodies does Planet Earth need?” wondered Dr. Roy Baynes, a senior vice president at Merck, which received approval for its first such drug in 2014.
Immunotherapy trials have proliferated so quickly that major medical centers are declining to furnish patients to them. The Yale Cancer Center participates in fewer than 10 percent of the immunotherapy trials it is asked to join. The problem is that many of the trials are uninteresting from a scientific view, said Dr. Roy Herbst, the center’s chief of medical oncology. The companies sponsoring these trials are not addressing new research questions, he said; they are trying to get proprietary drugs approved. If the struggle to find patients for immunotherapy trials is challenging, finding patients for another new type of cancer treatment can be next to impossible.
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