The immune checkpoint inhibitor, Imfinzi (durvalumab), has demonstrated beneficial overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive) and safety for patients with advanced or metastatic non-small cell lung cancer (NSCLC) and limited performance status, according to a news release.
Imfinzi is a type of monoclonal antibody and immune checkpoint inhibitor that binds to the protein PD-L1, which helps the immune system kill cancer cells more effectively, as defined by the National Cancer Institute.
In a recent study published by eClinicalMedicine, researchers from the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center found that patients with advanced or metastatic NSCLC and a limited physical performance status showed positive results after receiving Imfinzi as treatment.
In particular, the respective study noted that patients who have better physical function and the ability to perform daily activities alone are often eligible for clinical trials. However, the study’s researchers delved into how treatment may benefit underrepresented patients — people who have less physical function and ability to perform daily tasks.
“Clinical trials for drug approvals have very selective eligibility criteria, so there is concern that study patient populations don’t always reflect the real world,” Dr. Liza Villaruz, senior study author, associate professor of medicine at the University of Pittsburgh and co-leader of the immunotherapy and drug development center at UPMC Hillman, said in the news release.
“A strength of our study is that it was done across community-based clinics in rural and underserved areas in patients with limited performance status, so this is a real-world patient population,” Villaruz said.
There were 50 total patients in the phase 2 trial led by Villaruz, in which 47 patients received Imfinzi as first-line treatment. The median OS was six months for patients with PD-L1-negative tumors and 11 months for patients with PD-L1-positive tumors, with a median follow-up of 28 months, according to the study.
Nine patients experienced severe treatment-related side effects out of the 47 patients who received Imfinzi.
READ MORE: Imfinzi Plus Radiotherapy Is ‘Promising’ for Certain Patients With NSCLC
Health-related quality of life was analyzed at baseline and during treatment and was not found to have a significant change from baseline through treatment, according to the findings of the study. The results also determined that Imfinzi was not only safe and well-tolerated but also showed an “encouraging” benefit to OS for patients specifically with PD-L1-positive tumors.
“Although our study did not have a control group, the findings suggest that (Imfinzi) has a survival benefit for NSCLC patients with PD-L1-positive tumors and borderline performance status,” said Villaruz in the news release. “Importantly, it gives us reassurance that (Imfinzi) is safe, well-tolerated and is associated with stable quality of life.”
Villaruz emphasized that more than one-third of patients with advanced or metastatic NSCLC have borderline performance status, meaning they have less physical function and ability to perform tasks alone. Nevertheless, this patient population is not often included in trials.
“We show that it’s feasible to conduct clinical trials with medically complex patients who may not be able to travel to larger academic hubs,” Villarez explained. “The ability to do clinical research within that patient population at rural cancer sites is important for improving representation within clinical trial findings.”
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