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June 12, 2024
Results from the phase III ADRIATIC trial, presented at this year’s American Society of Clinical Oncology (ASCO) conference, indicated that durvalumab (brand name Imfinzi) improved overall survival (OS) and progression-free survival (PFS) for patients with limited-stage small cell lung cancer (LS-SCLC).
The trial demonstrated that Imfinzi had a statistically significant and clinically meaningful improvement in the dual primary endpoints of OS and PFS in LS-SCLC patients who had not progressed following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT.
Because SCLC is a highly-aggressive form of lung cancer that typically recurs and progresses rapidly, the prognosis has historically been poor. Only about 15-30% of patients are alive five years after diagnosis.
“Many patients treated for limited-stage small cell lung cancer face disease recurrence and the standard of care has remained unchanged for decades. ADRIATIC is the first global Phase III immunotherapy trial to deliver significant, clinically meaningful improvement in survival in this setting, marking a breakthrough for patients with this devastating disease,” Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Center, The Netherlands, and principal investigator in the trial, said in a press release.
Dr. Lauren Byers, thoracic section chief in the Department of Thoracic-Head & Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, called ADRIATIC a “landmark study” that “provides a new standard of care with the addition of immunotherapy for patients with early-stage SCLC who are being treated with a goal of curing their cancer.”
The Data
The study enrolled a total of 730 patients with stage I to III LS-SCLC who completed four cycles of concurrent thoracic radiation therapy (CRT) within 1 to 42 days. Patients were randomized in a ratio 1:1:1 to receive Imfinzi alone, or in the other group, Imfinzi alongside tremelimumab for up to four doses, followed by Imfinzi up to 24 months.
- Progression-free survival (PFS) was significantly prolonged in the group that received Imfinzi (16.8 months vs. 9.2 months)
- Overall survival (OS) was also better in the Imfinzi group (55.9 months vs. 33.4 months)
The rate of severe side effects was the same in both groups: 24%.
About 16% of the participants in the Imfinzi group stopped treatment because of side effects compared to 11% in the placebo group. About 38% of participants in the Imfinzi group developed pneumonitis (inflammation of the lung tissue) compared to 30% in the placebo group.