Imfinzi gains EU approval in resectable NSCLC, bolstering AstraZeneca’s oncology pipeline

The European Commission has approved AstraZeneca’s Imfinzi-based perioperative regimen for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence, and whose tumours lack epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This new treatment protocol involves administering Imfinzi (durvalumab) alongside neoadjuvant chemotherapy before surgery and continuing with Imfinzi alone after surgery. The approval is based on positive results from the AEGEAN Phase III trial, which demonstrated significant clinical benefits in event-free survival (EFS) and pathologic complete response (pCR).

The decision represents a milestone in the treatment of early-stage NSCLC, a disease that, despite being caught at a surgically treatable stage, often returns aggressively. Until now, treatment options in Europe for patients eligible for surgery have remained largely confined to chemotherapy with modest survival gains. The Imfinzi-based perioperative regimen introduces immunotherapy into both pre- and post-operative phases, creating a new standard of care with the potential to extend survival and reduce recurrence.

What did the AEGEAN trial reveal about Imfinzi’s impact on lung cancer recurrence?

The AEGEAN Phase III trial enrolled 802 patients globally and evaluated the effectiveness of perioperative Imfinzi in resectable Stage IIA to IIIB NSCLC. Participants received four cycles of neoadjuvant chemotherapy, either combined with Imfinzi or a placebo, followed by surgical resection. Post-surgery, patients in the treatment arm continued to receive Imfinzi monotherapy for up to 12 cycles. The study design excluded patients with EGFR or ALK mutations, focusing on a population that typically responds to immunotherapy.

A planned interim analysis of EFS, one of the trial’s primary endpoints, showed a statistically significant 32% reduction in the risk of disease recurrence, progression or death in patients receiving the Imfinzi-based perioperative regimen compared to chemotherapy alone. The EFS hazard ratio was 0.68 (95% CI: 0.53–0.88; p=0.003902), based on 32% data maturity. In addition, the final analysis of pathologic complete response revealed a 17.2% pCR rate in the Imfinzi arm versus 4.3% for the control group — a more than four-fold improvement.

While overall survival (OS) data remain immature, early findings presented at the 2024 World Conference on Lung Cancer indicated a favourable trend. Median OS was not yet reached in the Imfinzi group compared to 53.2 months in the chemotherapy-alone group, with a hazard ratio of 0.89 (95% CI: 0.70–1.14). OS will continue to be monitored as a key secondary endpoint.

Safety outcomes were consistent with known Imfinzi profiles, and there were no new safety signals. Importantly, the addition of Imfinzi did not compromise patients’ ability to undergo surgery, reinforcing the regimen’s feasibility in real-world clinical practice.

How does this approval change treatment for resectable non-small cell lung cancer?

Despite advances in diagnostic imaging and early detection, outcomes for early-stage lung cancer patients remain poor due to high relapse rates. Each year, over 450,000 individuals in Europe are diagnosed with lung cancer, and approximately 25–30% of NSCLC patients are deemed eligible for surgery with curative intent. Yet even after tumour resection and adjuvant chemotherapy, recurrence is frequent, and survival rates remain unacceptably low. Only 36–46% of Stage II patients survive five years post-diagnosis; this drops to 24% for Stage IIIA and just 9% for Stage IIIB disease.

The approval of the Imfinzi-based perioperative regimen addresses this unmet need by introducing immune checkpoint inhibition during a critical therapeutic window — before and after surgical resection. This integrated approach helps prime the immune system early and maintain suppression of residual disease post-surgery. Experts believe this paradigm shift may redefine the treatment strategy for thousands of patients in Europe annually.

Professor Martin Reck, head of thoracic oncology at Lung Clinic Grosshansdorf and a member of the AEGEAN Steering Committee, stated that the regimen meaningfully improved outcomes in a curative-intent setting and should now form a core part of lung cancer treatment protocols in Europe. His remarks underscore growing consensus among clinicians that perioperative immunotherapy may eventually become standard care in early NSCLC.

How does this approval strengthen AstraZeneca’s oncology strategy?

The approval of the Imfinzi-based perioperative regimen adds another high-impact indication to AstraZeneca’s growing oncology portfolio. Imfinzi, a PD-L1 inhibitor, has already become a global standard in unresectable Stage III NSCLC following the success of the PACIFIC trial. It is also approved for small cell lung cancer (SCLC), biliary tract cancer, hepatocellular carcinoma, and several gynecologic malignancies, often in combination with other agents such as Imjudo (tremelimumab) or Lynparza (olaparib).

In March 2025, the MATTERHORN Phase III trial confirmed that perioperative Imfinzi combined with chemotherapy improved EFS in resectable gastric and gastroesophageal junction cancers, potentially opening another front in the drug’s commercial lifecycle. The current EU approval for early-stage NSCLC builds on this momentum, underscoring the drug’s versatility and reinforcing AstraZeneca’s leadership in immuno-oncology.

According to AstraZeneca’s Oncology Haematology Business Unit EVP Dave Fredrickson, the approval represents a major advance in transforming outcomes for patients in the early stages of lung cancer. He noted that this new indication not only supports broader use of Imfinzi but also demonstrates AstraZeneca’s commitment to intervening earlier in the cancer care continuum, where the opportunity for cure is greatest.

How has AstraZeneca’s stock responded to this regulatory milestone?

AstraZeneca plc, which trades on the London Stock Exchange under the ticker AZN, has seen a positive uptick in its stock price, reflecting investor confidence in the commercial prospects of the Imfinzi-based perioperative regimen. As of April 3, 2025, AZN was trading at approximately £108.20, a gain of around 3.5% over the past month. Analysts expect the recent EU approval to support sustained growth in oncology revenue over the next two to three years.

Major financial institutions, including Morgan Stanley and Jefferies, have reiterated “Buy” or “Hold” ratings on the stock, with price targets in the £115–£120 range. These analysts point to the robust pipeline and expanding immuno-oncology footprint as key value drivers. However, AstraZeneca’s price-to-earnings ratio of 34x suggests that high growth expectations are already priced in, and future performance will hinge on successful regulatory follow-through and clinical data maturity.

For long-term investors, the latest approval reinforces AstraZeneca’s position as a leading innovator in oncology, with Imfinzi playing a central role in the firm’s immunotherapy strategy. For existing shareholders, it may be wise to hold, particularly as data from the MATTERHORN trial and potential approvals in Japan could act as catalysts. Short-term traders, however, may see limited upside unless further positive developments emerge quickly.

What does this mean for the future of perioperative immunotherapy?

The EU’s decision to approve the Imfinzi-based perioperative regimen marks a broader shift in how oncologists approach early-stage cancers. For decades, the focus in NSCLC was on late-stage treatment with systemic therapies. Now, with growing evidence from AEGEAN and other trials, perioperative immunotherapy is gaining traction as a strategy to eliminate microscopic disease before it can spread or return.

As national health agencies across Europe begin integrating this new protocol into clinical practice, its impact on survival rates and healthcare costs will become clearer. Reimbursement decisions, patient uptake, and long-term data will shape how broadly the regimen is adopted. For now, the approval marks a meaningful advance for patients and represents a strategic win for AstraZeneca, whose ability to bring immunotherapy into earlier stages of disease may change how lung cancer is treated for years to come.