Checkpoint Immunotherapy Is Safe for HIV-Positive People With Cancer

[Jim Allen]

Good news & progress.

Full write-up: https://www.poz.com/article/checkpoint-immunotherapy-cancer-safe-effective-people-hiv

It's a long publication but in short:

To date, there has been limited research on immunotherapy for HIV-positive people with cancer, as they have generally been excluded from oncology clinical trials.

Fortunately, this is changing. Last November, at the urging of ASCO and Friends of Cancer Research, the National Cancer Institute and the Food and Drug

Keytruda

In the first study, sponsored by the National Cancer Institute, Thomas Uldrick, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues evaluated whether Keytruda is safe for people living with HIV and advanced cancer across a range of CD4 cell counts.

The participants had relapsed or refractory (nonresponsive) cancers and were not eligible for other standard therapies. Eleven had AIDS-defining cancers: six with KS and five with NHL. The remaining 19 had non-AIDS cancers

Everyone in this open-label trial was treated with Keytruda, administered as a 200-milligram intravenous infusion every three weeks for up to two years, or until they experienced cancer progression or unacceptable side effects. They also continued taking antiretrovirals throughout the study.

One person with lung cancer experienced a complete response, or full remission; two people with NHL had partial responses. Two patients experienced an unusual type of paradoxical lymphoma response sometimes seen with immunotherapy. Two people with KS had stable disease, meaning no further cancer progression, for six months or more, and 13 others had stable disease for less than six months at the time of the analysis. Uldrick reported that one person with liver cancer that had spread to the bones did not meet partial response criteria but had reduced pain and improved biomarkers lasting more than two years after stopping Keytruda. Finally, eight people experienced cancer progression.

“Our conclusion is that anti-PD-1 therapy is appropriate for cancer patients with well-controlled HIV, and that patients with HIV and cancer can be treated with the drug and should be included in future immunotherapy studies,” Uldrick said in a Fred Hutch press release.


Imfinzi

In the second study, María González-Cao, MD, PhD, of Instituto Oncológico Dr. Rosell in Barcelona, and colleagues evaluated the safety and feasibility of Imfinzi for people with HIV.

The Phase II DURVAST trial enrolled 20 HIV-positive people with advanced solid tumors at 18 hospitals in Spain. Sixteen were men and the median age was 54. People with a history of injection drug use, gay men and heterosexuals were all well represented.

Fourteen had non-small-cell lung cancer, one had small-cell lung cancer, two each had melanoma and anal cancer, and one had bladder cancer. One in four were starting first-line cancer treatment, while the rest were on their second to fourth treatment attempts.

Four people (20%) experienced partial tumor shrinkage and five others (25%) had stable disease, González-Cao reported. Just over half (55%) experienced disease progression. At the time of the analysis, nine people remained on treatment.

Imfinzi, too, was safe and well tolerated. Most people experienced mild or moderate side effects, but only two had severe or life-threatening adverse events.

Taken together, these prospective studies focusing on people living with HIV show that PD-1/PD-L1 checkpoint inhibitors are safe for this population, with response rates and adverse event profiles similar to those seen in HIV-negative people