A group of doctors says more people with immune systems compromised by cancer or other diseases are likely to be left out of treatment because of the current limited use of a potentially lifesaving treatment.
The Organ Cancer Coalition is asking the U.S. Food and Drug Administration (FDA) to establish a medical pathway for administering a fourth immune system booster, or checkpoint inhibitor, to patients with cancer who don’t respond to previous immunotherapy treatment.
Led by Richard Arduini, M.D., a stem cell expert at the University of California, San Francisco, the research team found that although melanoma patients responded to the checkpoint inhibitor Imbruvica, 26 percent did not continue treatment. Similarly, lung cancer immunotherapy patients on PD-1 inhibitors including Opdivo, Yervoy and Keytruda also had a high rate of discontinuation, although a smaller percentage.
“Unnecessary discontinuation of treatment raises serious safety concerns, especially in patients with complicated treatment histories,” said Arduini. “It’s high time that physicians and clinicians became more aware of this and should provide more information to those being treated.”
Coalition members also called for earlier decision-making on the use of certain immunotherapies to avoid inadequate levels of treatment dosing.
“Due to the success of these therapies, thousands of patients have been caught up in the oncology approval process,” said Arduini. “It is especially important for medical professionals to know which therapies they should offer or retreat so as to avoid unnecessary and painful discontinuation of treatment.”
Commonly used as first-line therapy for melanoma and lung cancer, checkpoint inhibitors such as Keytruda and Opdivo have helped hundreds of thousands of people with these deadly diseases.
Arduini and his colleagues point out that, while these agents show remarkable success against cancer, they often do not work in every patient or in patients with an incomplete response to prior immunotherapy.
“Many patients who have been successfully treated with these therapies also have serious health problems due to their compromised immune systems,” said Arduini. “This is especially so in cases where cancer has spread, or become resistant to prior treatment.”
The organization noted that while many insurers already offer coverage for the four immunotherapy drugs, few of these policies allow continuation of treatment after treatment with the first checkpoint inhibitor. As such, they argue that existing policies need to be expanded so that insurance companies can cover continuation of post-immunotherapy treatment.
“We envision health policy standards that would include language about the duration of post-immunotherapy therapy,” Arduini said. “Such policies could also include language about development and tracking of the outcomes of patients who, after receiving multiple immunotherapies, have been subjected to enough stimulus to create persistent immune dysregulation that many still don’t respond to traditional treatment.”
The US cancer institute currently has a control arm and an experimental arm in which patients are randomized to treatment with three different types of immunotherapy agents. It plans to extend these trials and, with funding from the National Cancer Institute, create a comprehensive trial involving thousands of patients.
Sources: CNN, American Academy of Immunology, ARG International
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