Durvalumab May Be ‘Feasible’ For HIV-Positive Cancer Patients

Author: By Lynda Williams, Senior medwireNews Reporter 

medwireNews: Early results from the DURVAST study suggest that durvalumab might be an option for the treatment of advanced cancer in patients who are undergoing combination antiretroviral therapy (cART) for HIV type 1 (HIV-1) infection. 

The phase II open-label trial assessed the feasibility of the PD-L1 inhibitor durvalumab at a dose of 1500 mg every 4 weeks in 20 patients, aged a median of 54 years, with advanced non-small-cell lung cancer (NSCLC; n=14), melanoma (n=2), anal carcinoma (n=2), small-cell lung cancer (n=1) or bladder cancer (n=1). 

All the participants were on stable cART and had undetectable plasma levels of HIV-1, and 60% had previously progressed after cancer therapy, explain Maria Gonzalez-Cao, from Dexeus University Hospital in Barcelona, Spain, and co-investigators. 

At data cutoff the patients had received a median four cycles of treatment, rising to a median of 11 cycles of treatment for the eight individuals who were continuing with durvalumab at the time of analysis. 

Overall, 50% of the group experienced drug-related adverse events (AEs) at grade 1 or 2, most commonly arthyromyalgia (55 and 10%, respectively), asthenia (45 and 10%) and diarrhoea (10 and 10%). 

There were no grade 3 or 4 drug-related AEs, immune-related AEs such as pneumonitis or hypothyroidism, or drug-related deaths. Nor were there any AEs linked to HIV-1 reactivation, and both CD4+ and CD8+ T-cell counts were stable during treatment, the researchers write in JAMA Oncology. 

Over a median of 12.7 months of follow-up, four of the 16 patients evaluable for tumour response experienced a partial response that lasted at least 4, 6, 12 and 14 months, respectively. And a further 31% of patients achieved stable disease including four individuals for whom this response lasted between at least 6 and 16 months. 

Noting that the “antitumoral activity of durvalumab in our study was higher than anticipated”, the team remarks that “[a]lthough 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 acitivty.” 

Maria Gonzalez-Cao and DURVAST study co-authors conclude that their trial “demonstrates that immunotherapy with durvalumab in HIV-1-infected people is feasible and safe”, in line with the limited earlier findings for pembrolizumab in HIV-1-positive NSCLC patients and durvalumab in NSCLC patients without the infection. 

“Larger studies are needed to validate the suggested favorable antitumoral activity of durvalumab in HIV-1–infected people”, the investigators say.

“HIV-1–infected patients with advanced cancer should have access to cancer therapies with immune checkpoint inhibitors”, they recommend. 

Reference  

Gonzalez-Cao M, Morán T, Dalmau J, et al. Assessment of the feasibility and safety of durvalumab for treatment of solid tumors in patients with HIV-1 infection. The phase 2 DURVAST study. JAMA Oncol; Advance online publication 9 April 2020. doi:10.1001/jamaoncol.2020.0465