* The safety analysis set includes all randomized patients who received ≥1 dose of study Tx; AEs were graded using Common Terminology Criteria for Adverse Events v5.0.

† First dose of study treatment until the date of surgery or, for patients without surgery, up to the earliest of: last dose of neoadjuvant treatment + 90 days, first dose of subsequent anti-cancer treatment, or the DCO date.

‡ Date of surgery (inclusive) to the earliest of 90 days post-surgery, first dose of subsequent anticancer treatment, or DCO date.

‡‡ First dose of study treatment post-surgery until earliest of: last study treatment postsurgery + 90 days, date of first dose of subsequent anti-cancer treatment, or the DCO date.

†† First dose of study treatment until the earliest of: the last dose of study treatment or surgery (taking the latest dose of D / PBO / CT / date of surgery) + 90 days, date of the first dose of subsequent anti-cancer treatment, or the DCO date.

€ In the IMFINZI^® arm: 2 fatal AEs were also reported in the adjuvant period (aortic aneurysm rupture and ILD); 3 fatal AEs were assessed as possibly related to study treatment (pneumonitis, ILD, and imLD), 2 of which were also assessed as possibly related to surgery (pneumonitis and ILD), 4 fatal AEs were assessed as unrelated to either treatment or surgery (COVID-19 pneumonia, COVID-19, pneumonia, and pneumonia streptococcal), and 4 fatal AEs were assessed as possibly related to surgery (septic shock, pneumonia, bronchopleural fistula/ pneumonia/septic shock, and post-procedural pulmonary embolism). In the Placebo arm: 4 fatal AEs were assessed as possibly related to surgery (pulmonary haemorrhage, infectious pleural effusion, acute respiratory failure, and pneumonia) and 5 fatal AEs were assessed as unrelated to surgery or treatment (multiple organ dysfunction syndrome, duodenal ulcer perforation, pneumonia/decreased appetite, COVID-19 pneumonia, and pneumonia).

§ During the overall period, included interstitial lung disease (n=2) and immune-mediated lung disease, pneumonitis, hemoptysis, myocarditis, and decreased appetite (n=1 each) in the D arm and pneumonia and infection (n=1 each) in the PBO arm. During the adjuvant period, included interstitial lung disease in the D arm and infection in the PBO arm.

¶ An AE of special interest consistent with an immune-mediated mechanism of action, where there is no clear alternate etiology, and requiring the use of systemic corticosteroids or other immunosuppressants and/or, for specific endocrine events, endocrine therapy.

** Pneumonitis is summarized as a grouped term comprising the ‘pneumonitis’, ‘interstitial lung disease’, and ‘immune-mediated lung disease’ preferred terms.

AE: adverse event; COVID-19: coronavirus disease 2019; CT: chemotherapy; D: durvalumab; DCO: data cut-off; ILD: interstitial lung disease; imLD: immune-mediated lung disease; NA: not assessed; PBO: placebo; SAE: serious AE; Tx: treatment.