1275P Extended Follow-Up of DURVAST Trial: A Phase II Study Evaluating Durvalumab Treatment in HIV-1-infected Patients with Solid Tumours by the Spanish Lung Cancer Group

Concerns about the safety of PD-1/PD-L1 blockade in human immunodeficiency virus type 1 (HIV-1)-infected individuals have led to the exclusion of these patients from clinical trials on cancer immunotherapies. In order to evaluate the feasibility of durvalumab treatment in HIV-patients with advanced cancer we conducted the DURVAST study, a non-randomized, open-label, phase 2 clinical trial that demonstrated clinical activity with acceptable toxicity rates in this setting. Here we present the long-term clinical outcomes of the study. Study population comprised eligible patients with any solid tumor type in which anti-PD-1/PD-L1 antibodies have approved indications. All patients had basal undetectable plasma viremia under combination antiretroviral therapy. Treatment consisted of durvalumab (1500 mg every four weeks) until disease progression or unacceptable toxicity. A total of 20 HIV-1-infected patients with advanced cancer, including 15 lung cancer patients, were enrolled. At a median follow-up of 24.6 months, prior findings were confirmed. At data cut off March 2020, 16 patients have died (ten due to cancer progression, while six due to non-drug related AEs), three patients have discontinued treatment due to tumor progression and one patient continues on therapy with a complete response. A median of four cycles of durvalumab has been administered (range, 1-35). Most drug-related adverse events were G 1-2 (35%) consisting mainly in diarrhea, asthenia and arthromyalgia. Two (10%) patients presented additional G3 toxicity during the extended follow-up, consisting on pancreatitis and hepatic toxicity. No drug-related deaths occurred with extended follow-up. Disease control rate continues to be 50%, without additional responses during the extended follow-up. Median duration of clinical benefit was 7.5 (range 3-29+) months. Median progression free survival and overall survival were 1.9 (CI95% 1.4-5.4) and 9.1 (CI95% 2.3-18.5) months, respectively. The overall safety profile along with the ongoing response observed in the trial, was consistent with that observed in previously reported analysis.