The results of a study has shown that patients living with HIV and one of a variety of potentially deadly cancers could be safely treated with the immunotherapy drug Pembrolizumab ( Keytruda ).
The adverse events profile, a measure of the safety of the drug in the study, was not substantially different from prior studies that excluded such patients.
The results are likely applicable to five similar drugs that block receptors known as PD-1 or PD-L1 on the surface T cells.
The 30-patient trial studied only Pembrolizumab, the anti-PD-1 therapy.
National Cancer Institute ( NCI ) sponsored the trial.
HIV-positive patients with different cancers that might respond to the drug were included in the trial.
Among the cancers treated were lung cancer; Kaposi sarcoma; non-Hodgkin lymphoma; liver cancer; anal cancer and advanced squamous cell skin cancer.
The study was conducted at seven different cancer centers across the United States, including the HIV and AIDS Malignancy Branch of the National Cancer Institute, in Bethesda, Maryland.
Overall, the safety profile of Pembrolizumab in people with HIV and cancer was similar to that noted in clinical trials in the general population.
Although the primary purpose of the study was to evaluate safety, it also provided a snapshot of the anti-cancer activity of the drug on these patients.
One patient with lung cancer had a complete response to treatment, and activity was also noted in important HIV-associated cancers, including non-Hodgkin lymphoma, Kaposi sarcoma and liver cancer.
An unexpected death on study from a rare KSHV-associated B-cell lymphoproliferation was noted in one patient and while the association with therapy is still unclear, it has led to recommendations to use substantial caution if anti-PD-1 therapy is considered in the setting of KSHV-associated multicentric Castleman disease.
The researchers concluded that anti-PD-1 therapy may be considered for FDA approved indications in patients with HIV who are on antiretroviral therapy and have a CD4 count above a certain threshold ( 100 cells per microliter of blood ).
However, more research is needed as to its effectiveness in the setting of HIV infection.
The FDA and the American Society of Clinical Oncology ( ASCO ) have all recommended that HIV patients should be included in more clinical trials.
The NCI has generally allowed patients with HIV to enroll on the immuno-oncology studies that it sponsors with PD-1 and PD-L1 inhibitors.
However, this trial was one of only two trials sponsored by the NCI to focus exclusively on patients living with HIV, and it has been the first prospective trial to report its results.
Exclusion of people with HIV in clinical trials is a longstanding problem that grew out of the poor outcomes of AIDS patients with cancer, before there were effective antiviral therapies for HIV.
In prior research, 46 recent clinical trials that led to approval of cancer drugs were surveyed, and found 30 contained explicit exclusions for patients with HIV, and nine others where an exclusion was implied.
In conclusion, 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. ( Xagena )
Source: Fred Hutchinson Cancer Research Center, 2019