Patients Benefiting from Immune Checkpoint Inhibitor Drugs Limited

Slightly over a third of cancer patients are eligible for immune checkpoint inhibitor (ICI) drugs but even fewer are responding to the innovative treatment, according to researchers from Oklahoma State University.

In the cross-sectional study published in JAMA Network Open, researchers carried out two calculated scenarios and found that US cancer patients eligible for immune checkpoint inhibitor (ICI) therapy was 38.5 percent and 36.1, respectively.

In 2018, the FDA limited the use of pembrolizumab and atezolizumab to patients with urothelial cancer who were not eligible for cisplatin-containing therapy, the report stated. 

Therefore, the first scenario used 2019 estimations assuming that FDA limits were specific to pembrolizumab and atezolizumab, and the second was 2019 estimations assuming that all immunotherapies approved for urothelial cancers are limited to patients with programmed death-ligand 1 expression who are cisplatin ineligible. 

Researchers previously reported that 12.5 percent of cancer patients responded to ICI therapy. But in this study of US cancer patients, the estimated total responses to these drug scenarios was 11.4 percent and 10.9 percent, respectively.  

Nearly nine percent of people who were eligible for ICIs in 2018 were later deemed ineligible because of negative confirmatory trials. And the 7.5 percentage point decrease in eligibility from the prior 43.6 percent estimate is due to negative results of phase three trials, experts stressed.

The disruption in numbers is largely due to increases in eligibility from other indications such as in triple-negative breast cancer (3.5 percent). Hepatocellular, urothelial, and gastric cancers had the largest negative differences at -4.9 percent, -2.3 percent, and -1.8 percent, respectively. 

Although ICI drugs have gained popularity in recent years due to their ability to boost a person’s immune response against cancer cells, experts highlighted that with quick approval of potentially beneficial drugs comes a high risk of approving drugs that are later found ineffective. 

Last January, Vanderbilt University Medical Center (VUMC) and GE Healthcare announced a partnership to launch immunotherapy for cancer patients using artificial intelligence (AI). 

The collaboration intends to create predictive analytics for innovative diagnostic tools. This will ensure researchers and clinicians more precision and patient personalization when choosing necessary immunotherapies. 

“Immunotherapy offers tremendous promise but given the current unpredictability of some patients’ reactions to treatments, it is also associated with increased morbidity and cost,” Jeff Balser, MD, PhD, president and CEO and dean of VUMC, said in the announcement. 

Artificial intelligence has become increasingly useful in different sectors of the healthcare space. For immunotherapies, AI algorithms will be applied to genomic, tumor, cellular, proteomic, and imaging data in the patients’ records. This will further researchers understanding of each individual’s response to different immunotherapies. They will then be able to accurately predict the effectiveness of certain treatments on future patients with similar profiles. 

“GE Healthcare and Vanderbilt will combine their data science, genomic imaging and cellular analysis capabilities to help improve clinical decision making,” said Kieran Murphy, president and CEO of GE Healthcare.

Researchers from the respective health systems are also developing new types of positron-emission tomography (PET) imaging tracers to leverage AI, help populate clinical trials, and speed up the drug development process. This can quicken the speed of bringing new therapies into the market. 

Balser believes that immunotherapy has the potential to reshape cancer worldwide, but strong partnerships are vital for extensive clinical research and product development. 

“Making any new therapeutic advancement available for everyone requires intensive ongoing efforts, beyond the initial introduction of the therapy into the healthcare ecosystem. Close partnerships between research institutions and industry are essential to making nearly all therapies, including immunotherapy, readily available,” he said in a statement.