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IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of adults with resectable (tumours ≥4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements.2
AEGEAN was a large (n=802), randomised, double-blind, multi-centre, placebo-controlled, global, Phase III study in patients with resectable NSCLC (Stage IIA–IIIB [N2]) with no known EGFR mutations or ALK rearrangements. Patients were randomly assigned in a 1:1 ratio to receive neoadjuvant platinum-based chemotherapy plus either fixed-dose durvalumab (1500 mg) Q3W or placebo Q3W, followed by surgery. After surgery, patients continued to receive durvalumab or placebo intravenously Q4W for up to 12 cycles. The co-primary endpoints of the study were pCR and EFS (BICR).2,3
Operating through its mechanism of action as an immune checkpoint inhibitor, selectively blocks the interaction of PD-L1 with PD-1 and CD-80 to enhance antitumour immune responses and increase T-cell activation.2,3
The AEGEAN study significantly improved co-primary endpoints EFS and pCR for patients with Stage IIA–IIIB (N2) resectable NSCLC vs placebo + CT.3,4
The CheckMate 816 trial demonstrated that neoadjuvant nivolumab plus chemotherapy significantly improved EFS versus chemotherapy alone in patients with resectable stage IB–IIIA NSCLC (HR=0.63; P=0.005). Despite this advance, ~51% of patients had an EFS event (progression, recurrence, or death) by 4 years.5
The International Association for the Study of Lung Cancer commissioned a diverse international expert panel (20 healthcare professionals) to evaluate the current overall landscape and therapeutic recommendations for patients with resectable NSCLC.6
Perioperative IO + CT is a regimen that helps your practice align with the International Association for the Study of Lung Cancer recommendations, providing IO both before and after surgery.3,6
CT – chemotherapy; IO – immuno-oncology; NSCLC – non-small cell lung cancer; PD-L1 – programmed death ligand 1.
The AEGEAN study, one of the largest perioperative IO + CT trials, evaluated the efficacy of perioperative IMFINZI-based treatment in Stage IIA–IIIB (N2) resectable NSCLC (N=802).3
Adapted from Heymach JV et al. N Engl J Med 2023.3
ALK – anaplastic lymphoma kinase; CT – chemotherapy; DFS – disease-free survival; EFS – event-free survival; EGFR – epidermal growth factor receptor; IV – intravenous; MPR – major pathological response; NSCLC – non-small cell lung cancer; OS – overall survival; pCR – pathological complete response; PD-L1 – programmed death ligand 1; Q3W – every 3 weeks; Q4W – every 4 weeks.
Patients were randomly assigned in a 1:1 ratio to receive neoadjuvant platinum-based chemotherapy plus either fixed-dose IMFINZI (1500 mg) Q3W or placebo Q3W, followed by surgery. After surgery, patients continued to receive IMFINZI or placebo intravenously Q4W for up to 12 cycles. Patients were enrolled in AEGEAN regardless of PD-L1 expression.3
Populations at high risk of recurrence were well-represented in AEGEAN, including Stage IIIA/B patients (>70%) and N2 patients (~50%).3
| Characteristic† | IMFINZI group (N=366) | Placebo group (N=374) |
|---|---|---|
| Disease stage – no. (%)‡ | ||
| II | 104 (28.4) | 110 (29.4) |
| IIIA | 173 (47.3) | 165 (44.1) |
| IIIB | 88 (24.0) | 98 (26.2) |
| TNM stage, regional lymph nodes — no. (%) | ||
| N0 | 110 (30.1) | 102 (27.3) |
| N1 | 75 (20.5) | 87 (23.3) |
| N2 | 181 (49.5) | 185 (49.5) |
| Single-station | 141 (38.5) | 132 (35.3) |
| Multistation | 34 (9.3) | 40 (10.7) |
| Histologic classification — no. (%) | ||
| Squamous | 169 (46.2) | 191 (51.1) |
| Non-squamous | 196 (53.6) | 179 (47.9) |
| Planned neoadjuvant platinum agent — no. (%) | ||
| Cisplatin | 100 (27.3) | 96 (25.7) |
| Carboplatin | 266 (72.7) | 278 (74.3) |
Adapted from Heymach JV et al. NEJM 2023.3
*TNM system is used to describe the amount and spread of cancer in a patient’s body; T describes the size of the tumour and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other body parts).7
† Characteristics for which there were missing or other responses were histologic classification (0.3% of the patients in the IMFINZI group and 1.1% of those in the placebo group had other histologic classification), disease stage (0.3% in the IMFINZI group had stage IV disease and 0.3% in the placebo group had stage III [not otherwise specified] disease, as reported on the electronic case-report form), and N2 lymph node station stage (1.6% in the IMFINZI group and 3.5% in the placebo group had N2 disease with missing data on single-station vs. multistation classification).3
‡ Patients with stage IIA disease to stage IIIB (N2 node stage) disease according to the eighth edition of the AJCC Cancer Staging Manual were enrolled.3
AJCC – American Joint Committee on Cancer; mITT – modified intent-to-treat; TNM – tumour, node, metastasis.
AEGEAN Regimen significantly improved EFS for patients with Stage IIA–IIIB (N2) resectable NSCLC vs Placebo + CT alone.3,4
Adapted from Heymach JV et al. N Engl J Med 2023.3
The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3
CI – confidence interval; CT – chemotherapy; EFS – event-free survival; HR – hazard ratio; NR – not reached.
Adapted from Heymach JV et al. WCLC 2024.9
The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3 The EFS subgroup analysis was not powered to show differences between or within individual subgroups and was not formally tested for statistical significance.
*IA2 included data cutoff on 10 May 2024, with additional study follow up since IA1 data cutoff on 10 November, 2022. All patients had discontinued or completed study treatment at EFS IA2.9
CI – confidence interval; CT – chemotherapy; EFS – event-free survival; HR – hazard ratio; NR – not reached.
Prespecified subgroup analysis – mITT: the EFS benefit of the AEGEAN Regimen was maintained regardless of the planned neoadjuvant platinum agent (P-values not tested).9
Adapted from Heymach JV et al. WCLC 2024.9
The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3 Data maturity rate: 39.1%.9 The EFS subgroup analysis was not powered to show differences between or within individual subgroups and was not formally tested for statistical significance.9
CI – confidence interval; D – durvalumab; HR – hazard ratio; mEFS – median event-free survival; NR – not reached; PBO – placebo.
Adapted from Heymach JV et al. WCLC 2024.9
The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3 Data maturity rate: 39.1%.9 The EFS subgroup analysis was not powered to show differences between or within individual subgroups and was not formally tested for statistical significance.9
CI – confidence interval; D – durvalumab; EFS – event free survival; HR – hazard ratio; mEFS – median event-free survival; NR – not reached; PBO – placebo.
mITT population pre-defined subgroup analyses (P not tested): median EFS was not reached across all PD-L1 subgroups, including patients with PD-L1 <1%.9
Adapted from Heymach JV et al. WCLC 2024.9
Data cutoff: May 2024; data maturity: 39.1%.
*The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK aberrations.9
CI – confidence interval; CT – chemotherapy; EFS – event-free survival; mITT – modified intention-to-treat; NR – not reached; PD-L1 – programmed death ligand 1.
At study completion, pCR and MPR were observed in a greater percentage of patients receiving IMFINZI (17.2% and 33.2%) vs those receiving placebo (4.3% and 12.3%), respectively.3
Statistical analysis not performed on the final analysis; P<0.001 based on interim analysis (N=402).
Adapted from Heymach JV et al. N Engl J Med 2023.3
*The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3
CI – confidence interval; CT – chemotherapy; MPR – major pathological response; pCR – pathological complete response.
Data cutoff: 10 November 2022.3
*The mITT population included all patients who had undergone randomisation, excluding patients with documented EGFR or ALK alterations, who were enrolled before a protocol amendment.3
Among all patients who started adjuvant treatment, 68.6% and 63.7% completed all adjuvant treatment for the IMFINZI and placebo arms, respectively.9
The median (range) number of days from surgery to first adjuvant treatment dose was 50.0 (22–136) in the AEGEAN Regimen arm vs 52.0 (21–141) in the placebo + CT arm.4
Of those patients who started adjuvant IMFINZI or placebo, a similar proportion completed the adjuvant phase (68.6% vs 63.7%)9
| Trial phase - no. (%) | The AEGEAN Regimen arm (N=366) | Placebo (N=374) |
|---|---|---|
| Neoadjuvant phase | ||
| Received CT plus IMFINZI or placebo | 366 (100) | 371 (99.2) |
| Completed 4 cycles of both CT agents | 310 (84.7) | 326 (87.2) |
| Completed 4 cycles of IMFINZI or placebo | 318 (86.9) | 331 (88.5) |
| Surgery* | ||
| Underwent surgery | 295 (80.6) | 302 (80.7) |
| Completed surgery | 284 (77.6) | 287 (76.7) |
| Adjuvant phase | ||
| Started IMFINZI or placebo† | 242 (66.1) | 237 (63.4) |
| Completed IMFINZI or placebo | 166 (68.6) | 151 (63.7) |
| Discontinued IMFINZI or placebo | 76 (31.4) | 86 (36.3) |
| Ongoing IMFINZI or placebo | 0 | 0 |
Adapted from Heymach JV et al. WCLC 2024.9
Data cutoff: 10 May 2024 (n=802).9
*Surgery status was assessed by the investigator. Patients who underwent surgery were those for whom curative intent thoracic surgery was attempted, regardless of whether it was completed. Patients who completed surgery were those for whom curative intent thoracic surgery was completed (assessed at the time of surgery).9
†For patients to have been eligible for the AEGEAN Regimen or adjuvant placebo, surgery must have been completed with R0/R1 margins and no evidence of disease on post-surgical RECIST assessment.9
CT – chemotherapy.
| Trial phase - no. (%) | The AEGEAN Regimen (N=366) | Neoadjuvant placebo + CT (N=374) |
|---|---|---|
| Underwent surgery† | 295 (80.6) | 302 (80.7) |
| Stage II | 86/295 (84.3) | 96/302 (88.9) |
| Stage III | 209/295 (79.2) | 206/302 (77.4) |
| Completed surgery‡ | 284 (77.6) | 287 (76.7) |
| Stage II | 85/284 (83.3) | 93/287 (86.1) |
| Stage III | 199/284 (75.4) | 194/287 (72.9) |
| R0 resection | 269/284 (94.7) | 262/287 (91.3) |
| R1 resection | 12/284 (4.2) | 22/287 (7.7) |
Adapted from Heymach JV et al. N Engl J Med 2023 and Mitsudomi T et al. WCLC 2023.3,10
Data cutoff: 10 November 2022 (n=802).3,10
*Includes sleeve resection (incl. bronchial or arterial) and bilobectomy.10
†Surgery status was assessed by the investigator. Patients who underwent surgery were those for whom curative intent thoracic surgery was attempted, regardless of whether it was completed.3
‡Patients who completed surgery were those for whom curative-intent thoracic surgery was completed (assessed by the investigator at the time of surgery).3
CT – chemotherapy; mITT – modified intent-to-treat.
| The AEGEAN Regimen (N=400) | Neoadjuvant placebo + CT (N=402) | |
|---|---|---|
| Patients who did not undergo surgery† – no. (%) | 76 (19.0) | 75 (18.7) |
| Disease progression | 27 (6.8) | 30 (7.5) |
| Unfit for surgery‡ | 15 (3.8) | 10 (2.5) |
| Patient decision | 12 (3.0) | 17 (4.2) |
| Death§ | 9 (2.3) | 2 (0.5) |
| Adverse event | 7 (1.8) | 5 (1.2) |
| Surgical resection with curative intent performed outside of protocol | 2 (0.5) | 6 (1.5) |
| Investigator decision | 2 (0.5) | 2 (0.5) |
| Other/missing | 2 (0.5) | 3 (0.7) |
| Patients who completed surgery† – no. (%) | 310 (77.5) | 308 (76.6) |
Adapted from Heymach JV et al. N Engl J Med 2023 (supplementary appendix).4
*The ITT population included all patients who were randomised.4
†Surgery status was assessed by the investigator. Patients who underwent surgery were those for whom curative intent thoracic surgery was attempted, regardless of whether it was completed. Patients who completed surgery were those for whom curative intent thoracic surgery was completed.4
‡Includes responses of “unfit for surgery”, “inadequate lung function” and “inadequate cardiac function”.4
§Two deaths in the AEGEAN Regimen arm were not deemed related to the AEGEAN Regimen.4
CT – chemotherapy; mITT – modified intent-to-treat.
Get to know the AEGEAN safety profile
Learn more about the dosing details in the AEGEAN Regimen
Take a closer look at how IMFINZI works within the AEGEAN Regimen
GB-65615 | DOP: June 2025
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This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
GB-74216| DOP : February 2026
