Company: AZN
Filing Date: 2025-04-04
Form Type: 6-K
Source: 0001654954-25-003896
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-04-04
Form: 6-K
Chunk 2
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 confidence interval [CI] 0.53-0.88; p=0.003902). In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).

Additionally, interim overall survival (OS) results presented at the 2024 World Conference on Lung Cancer showed a favourable trend with the Imfinzi- based perioperative regimen (35% data maturity; median OS: not reached [NR] versus 53.2 months; HR=0.89; 95% CI 0.70-1.14). The OS data were not tested for statistical significance at this interim analysis and will continue to be assessed as a key secondary endpoint at final analysis.

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery versus chemotherapy alone.

Imfinzi is approved in the US, China and several other countries in this setting based on the AEGEAN results. Regulatory applications are currently under review in Japan and additional countries in this indication.

Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease as not progressed after chemoradiotherapy (CRT) based on the PACIFIC Phase III trial.

#### Notes

#### Lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 6-7 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of patients diagnosed with NSCLC. 8-9 An estimated 28,000 people are treated for resectable NSCLC across the five major European countries each year. 10

Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition. 11-12 The majority of patients with resectable disease eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy. 5

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