OU Health Stephenson Cancer Center Researcher Leads Global Study Investigating Immunotherapy Drugs for People Living With Cancer and HIV

Oncologists treating patients who are living with both cancer and HIV have historically lacked scientific data about whether immunotherapy drugs will be effective. A researcher at OU Health Stephenson Cancer Center at the OU Health Sciences Center co-led a global study that revealed good news for this patient population.

The study analyzed the safety and effectiveness of immune checkpoint inhibitors, a type of immunotherapy that helps the body recognize and attack cancer cells, in patients diagnosed with both cancer and HIV. The results, published today in the Journal of Clinical Oncology, show that immune checkpoint inhibitors are not harmful to people living with HIV and cancer and can successfully treat certain types of cancer. Stephenson Cancer Center was among 33 academic healthcare centers in North America, Europe and Australia that participated in the study.

“This study should give some level of confidence to clinicians who are treating patients living with HIV and cancer. They can use this data to guide discussions with their patients when considering immune checkpoint inhibitors. This will serve as a landmark paper in the field, given that little is known about immunotherapy among people with HIV and cancer,” said OU Health medical oncologist Abdul Rafeh Naqash, M.D., who led Stephenson Cancer Center’s participation in the study and was also the overall lead investigator for this study. Dr. Naqash is an assistant professor in the OU College of Medicine.

The knowledge gap regarding immunotherapy for people living with HIV and cancer results from the long-term exclusion of this patient population from clinical trials. Because some people living with HIV have impaired immune systems, the scientific community typically has been concerned that they would not respond to immunotherapy or that the drugs would be toxic to them. Because that’s not the case, pharmaceutical companies and the National Cancer Institute should broaden their clinical trial criteria to include more people living with HIV if their CD4 count (a type of white blood cell) is within an acceptable range, Naqash said.

The data analyzed in the study came from patients whose physicians decided to prescribe immune checkpoint inhibitors despite a lack of robust evidence. Though it was not a randomized clinical trial, the study is sufficiently strong to warrant an increased use of immunotherapy, Naqash said. People living with HIV are at higher risk than people without HIV for developing various cancers for which immune checkpoint inhibitors are the standard of care. That includes lung cancer, which is the second-leading cause of cancer death among people living with HIV. If immune checkpoint inhibitors are not prescribed to treat cancers for which they are already approved as the standard of care, those patients would be receiving a substandard treatment.

Researchers studied data from patients with at least 10 different types of cancers. They analyzed several additional factors, including whether CD4 counts influence outcomes and side effects and which tumors responded better to immune checkpoint inhibitors. Future publications detailing those findings are planned.

The study also underscored the importance of a multidisciplinary team treating patients living with HIV and cancer. Involving an infectious disease expert is especially important for monitoring the patient’s HIV viral count, watching for opportunistic infections, and ensuring compliance with antiretroviral drugs, Naqash said.

“We believe this study is a pivotal effort that will lead to further research in the HIV and oncology space to better inform treatment decisions for this patient population,” he said. “This is the largest data set to date to be analyzed for these particular study questions across different tumor types. This study is also important because it represents the real-world population that we would see in the clinic. It provides a level of assurance that immune checkpoint inhibitors are broadly safe for people with HIV and have the potential to effectively treat several types of solid tumor cancers.”