AstraZeneca has received the US Food and Drug Administration (FDA) approval for Imfinzi (durvalumab) plus chemotherapy to treat a type of lung cancer in adult patients.
Imfinzi is an anti-PD-L1 monoclonal antibody therapeutic, designed to counter the tumour’s immune-evading tactics and release the inhibition of immune responses.
The regimen comprises Imfinzi in combination with neoadjuvant chemotherapy for treating patients before surgery and as adjuvant monotherapy to treat patients after surgery.
It is approved to treat resectable early-stage (2A-3B) non-small cell lung cancer (NSCLC) and no known EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements.
AstraZeneca said that Imfinzi is the only drug approved in the curative-intent setting of unresectable, Stage 3 NSCLC in patients, for whom chemoradiotherapy stopped disease progression.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease.
“We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment.”
The FDA approval was based on positive results from AEGEAN, a randomised, double-blind, multi-centre, placebo-controlled global Phase 3 clinical trial.
The Phase 3 AEGEAN study evaluated Imfinzi as a perioperative treatment for patients with resectable Stage 2A-3B NSCLC, regardless of PD-L1 expression.
In the study, 802 patients were randomised to receive a 1,500mg fixed dose of Imfinzi plus chemotherapy or placebo plus chemotherapy.
The patients were given treatments every three weeks for four cycles before surgery, followed by Imfinzi or a placebo every four weeks, for up to 12 cycles after surgery.
The Imfinzi-based regimen showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, and progression, compared to chemotherapy alone.
In the AEGEAN study, Imfinzi was generally well tolerated, with no new safety signals observed in the neoadjuvant and adjuvant settings.
Imfinzi is already approved in the UK, Switzerland, and Taiwan in this setting, based on AEGEAN study results, and is currently under review in the EU, China, and other countries.
Recently, FDA granted a Priority Review for Imfinzi to treat limited-stage small cell lung cancer (LS-SCLC), whose disease has not progressed after concurrent chemoradiotherapy (cCRT).
