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Found 1 Presentation For Request "DURVAST"
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
- Maria Gonzalez Cao (Barcelona, Spain)
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
The overall safety profile along with the ongoing response observed in the trial, was consistent with that observed in previously reported analysis.
Clinical trial identification
NCT03094286.
Legal entity responsible for the study
Spanish Lung Cancer Group.
Funding
AZ Spain.
Disclosure
All authors have declared no conflicts of interest.