Durvalumab feasible for cancer patients with HIV
medwireNews: Phase 2 trial results point to the feasibility of treatment with the PD-L1 inhibitor durvalumab in people with advanced solid cancer and controlled type 1 HIV (HIV-1) infection.
Half of the 20 trial participants had disease control and there were no severe treatment-related adverse events (TRAEs), leading the DURVAST researchers to conclude that “HIV-1–infected patients on suppressive antiretroviral therapy with advanced cancer should have access to cancer immunotherapy treatments.”
They do, however, admit that “[l]arger studies are needed to validate the suggested favorable antitumoral activity of durvalumab” in this patient group.
The study enrolled 20 patients with advanced solid tumors and HIV-1 who were receiving effective combination antiretroviral therapy (cART). The majority of participants had non-small-cell lung cancer, occurring in 14 cases, followed by two cases each of melanoma and anal carcinoma and one case each of small-cell lung cancer and bladder cancer. Sixty percent had progressed on prior anticancer therapies and all had had undetectable plasma levels of HIV-1.
Participants received a median four cycles of durvalumab 1500 mg administered every 4 weeks, which meant that the primary endpoint of the study was met. Eight of the participants were continuing treatment at the time of data analysis, and had received a median of 11 cycles by that stage.
During a median follow-up of 12.7 months, 25% of the 16 evaluable patients achieved a partial response, lasting for 4, 6, 12, and 14 months, respectively. An additional four participants had durable stable disease, with durations of greater than 6–16 months, giving a disease control rate of 50%.
Highlighting that “the antitumoral activity of durvalumab in our study was higher than anticipated,” the investigators say: “Although the number of patients was small, it is not possible to rule out the fact that HIV-1 infection by itself, or the cART treatment, was positively associated with antitumoral activity.”
The toxicity profile of durvalumab was also favorable, with no grade 3 or 4 TRAEs. Arthromyalgia was the most common TRAE, occurring at grade 1 in 55% of participants and grade 2 in 10%, and asthenia was the next most frequent event, at corresponding rates of 45% and 10%.
Of note, there were no immune-related TRAEs, such as pneumonitis or hypothyroidism, no AEs related to reactivation of HIV-1, and none of the four deaths were deemed related to the study drug, report Maria Gonzalez-Cao (Dexeus University Hospital, Barcelona, Spain) and colleagues.
The DURVAST findings align with those from prior retrospective studies of PD-1 or PD-L1 inhibitors and also with a phase 1 trial of pembrolizumab in this patient population, they comment in JAMA Oncology.
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