AstraZeneca's Imfinzi shows event-free survival benefit in lung cancer patients in trial
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AstraZeneca (NASDAQ:AZN) said data from a phase 3 trial showed that Imfinzi-based therapy before and after surgery significantly increased the time patients with lung cancer lived without the disease recurring or progressing.
The late stage study, dubbed AEGEAN, is evaluating Imfinzi (durvalumab) as a perioperative therapy for patients with resectable stage 2A-3B non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.
Perioperative therapy includes therapy before and after surgery, also known as neoadjuvant/adjuvant treatment.
In the study, 802 patients received either Imfinzi plus chemotherapy or placebo plus chemo every three weeks for four cycles before surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) following surgery.
AstraZeneca said Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant standalone therapy after surgery showed a statistically significant and clinically meaningful improvement in event-free survival (EFS), compared to neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage NSCLC, according to an interim analysis.
The British pharma giant added that data from the final pathologic complete response (pCR) and major pathologic response (mPR) analyses were consistent with previously reported data.
"Patients with resectable non-small cell lung cancer face unacceptably high rates of recurrence, despite treatment with chemotherapy and surgery. We have shown that adding Imfinzi both before and after surgery significantly increased the time patients live without recurrence or progression events," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca.
The company noted that Imfinzi was well tolerated and no new safety concerns were seen in the neoadjuvant and adjuvant settings.
Adding Imfinzi to neoadjuvant chemotherapy was consistent with the profile for the combo and did not increase complications or adverse events or compromise patients' ability to go through surgery, compared to chemotherapy alone, the company added.
The trial will continue to evaluate key secondary goals, including disease-free survival (DFS) and overall survival (OS).
AstraZeneca said it will share the data with global health authorities and present the results at an upcoming medical meeting.
AZN +0.69% to $64.56 premarket March 9