AstraZeneca’s Imfinzi (durvalumab) significantly lengthened the time it took for a patient’s non-small cell lung cancer to progress after chemotherapy and radiation, a Phase 3 clinical trial showed.
The trial compared the use of Imfinzi with active surveillance of the disease, whose acronym is NSCLC. Researchers also tracked the time it took for a patient to die after chemo and radiation.
AstraZeneca presented the interim results of the PACIFIC trial (NCT02125461) at the European Society for Medical Oncology’s Asia Congress in Singapore, Nov. 17-19. The presentation was titled “PACIFIC: A double-blind, placebo-controlled Phase III study of durvalumab as consolidation therapy after chemoradiation in patients with locally advanced, unresectable NSCLC.”
The results also appeared in a New England Journal of Medicine article titled “Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer.”
The trial covered 709 patients whose NSCLC had become stable after two or more cycles of platinum-based chemotherapy and radiation, a combination called chemoradiotherapy.
Researchers randomized participants to receive either Imfinzi as a consolidation therapy, or a placebo, every two weeks for up to 12 months.
The study’s main goal was to see if Imfinzi improved patients’ overall survival and the time it took for their disease to progress or for a patient to die. Secondary measures included how many patients had responded fully or partially to treatment, the duration of their response, and how many had survived to two years.
It took a mean of 16.8 months for Imfinzi patients’ cancer to progress. For the placebo-treated patients, the figure was 5.6 months. This meant that Imfinzi reduced the risk of the disease progressing by 48 percent.
The response rate was 28 percent of patients in the Imfinzi arm, compared with 16 percent in the placebo arm. The median duration of response was also higher in the Imfinzi group. At 18 months, 73 percent of the Imfinzi patients continued to respond, compared with 47 percent in the placebo arm.
Severe to life-threatening adverse events occurred in 30 percent of Imfinizi patients and 26 percent of the placebo group. Cases of pneumonia were the most common.
Fifteen percent of the Imfinzi group and 10 percent of the placebo group discontinued the study because of adverse events.
The results showed that Imfinzi has the potential to become a new standard of care for lung cancer patients, Joris Silon, AstraZeneca’s Asia Area vice president, said in a press release. “Our commitment to improving outcomes in this tumor type extends from earlier- to late-stage disease and encompasses a wide array of scientific approaches that leverage different mechanisms to attack cancer,” he said. “The lung cancer burden is significant in Asia, and we are proud to share our progress with the medical community.”
At the moment, Imfinzi is approved in the United States only as a treatment for bladder and urinary tract cancers.
