According to new research, AstraZeneca’s Imfinzi (durvalumab) has a five-year survival rate of over 40% in patients with Stage III non-small cell lung cancer.
AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit at five years in patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy, according to updated Phase III trial results (CRT). Based on prior findings from this research, Imfinzi was authorized for unresectable Stage III NSCLC following CRT in the United States, Japan, China, the European Union, and many other countries.
The PACIFIC experiment was a multi-centre Phase III experiment that was randomised, double-blinded, and placebo-controlled. After CRT, individuals treated with Imfinzi had a five-year OS rate of 42.9 percent against 33.4 percent for those on placebo, according to revised post-hoc analysis. Imfinzi had a median OS of 47.5 months compared to 29.1 months for the placebo. Following a maximal treatment term of one year, 33.1 percent of Imfinzi patients had not progressed five years after enrollment, compared to 19 percent of placebo patients. The major PFS and OS evaluations published in The New England Journal of Medicine in 2017 and 2018 showed that Imfinzi provided a sustained, meaningful benefit for these key objectives.
Dr David Spigel, Chief Scientific Officer at the Sarah Cannon Research Institute and investigator in the PACIFIC trial, commented: “This trial has once again set a new precedent in the treatment of patients with unresectable, Stage III non-small cell lung cancer. Historically, only 15-30 percent of these patients survived five years but these results show that with up to one year of treatment with Imfinzi, an estimated 43 percent of patients are still alive at five years. Moreover, three-quarters of these patients had also not progressed in that time. This is a momentous achievement at the five-year landmark in this curative-intent setting.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca, said: “Five-year survival is a clinically significant and emotionally meaningful milestone for people with cancer and their families, and it’s incredible to see the majority of patients surviving that long have not progressed four years after completing treatment. These results – the first of their kind in Stage III unresectable lung cancer – reinforce the long-term benefit of Imfinzi as the established standard of care in this curative-intent setting. With trials like PACIFIC and our comprehensive development programme in early-stage disease across cancer settings, our strategy is to improve cancer outcomes by treating patients as early as possible, aiming to deliver life-changing treatments that increase the potential for cure.”
Cough (35.2 percent versus 25.2 percent), fatigue (24.0 percent versus 20.5 percent), dyspnoea (22.3 percent versus 23.9 percent), and radiation pneumonitis were the most common adverse events (AEs) (20 percent) among patients treated with Imfinzi versus placebo in the primary OS analysis of the PACIFIC Phase III trial (20.2 percent versus 15.8 percent). 30.5 percent of Imfinzi patients had a grade 3 or 4 AE, compared to 26.1 percent of placebo patients. Furthermore, 15.4 percent of Imfinzi patients terminated therapy owing to AEs, compared to 9.8 percent of placebo patients.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and disrupts its interaction with PD-1 and CD80, limiting tumour immune evasion and thereby relieving the suppression of anti-tumour immune responses.
AstraZeneca is conducting a number of registrational trials to see if Imfinzi can be used to treat lung cancer in its early stages, including in possibly curative situations (PACIFIC-2, 4 and 5, MERMAID-1 and 2, AEGEAN, ADJUVANT BR.31, and ADRIATIC Phase III trials). In two Phase II platform studies in the Stage III unresectable setting (COAST) and neoadjuvant early-stage setting, the business is also evaluating innovative combinations with Imfinzi (NeoCOAST).