Perioperative durvalumab plus platinum-based chemotherapy

The phase III AEGEAN trial (NCT03800134) investigated perioperative durvalumab plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with resectable (stage II to IIIB [N2]) NSCLC. Patients received four cycles of treatment every 3 weeks before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. The modified intention-to-treat population (740 patients) included all patients who were randomly assigned, excluding patients with documented EGFR or ALK alterations. The first planned interim analysis occurred with 31.9% data maturity and at a median follow-up of 1 year. The primary end points were EFS and pathological complete response.[14][Level of evidence B1]

The phase III AEGEAN trial (NCT03800134) investigated perioperative durvalumab plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with resectable (stage II to IIIB [N2]) NSCLC. Patients received four cycles of treatment every 3 weeks before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. The modified intention-to-treat population (740 patients) included all patients who were randomly assigned, excluding patients with documented EGFR or ALK alterations. The first planned interim analysis occurred with 31.9% data maturity and at a median follow-up of 1 year. The primary end points were EFS and pathological complete response.[14][Level of evidence B1]

At 12 months, the EFS rate was 73.4% for patients who received durvalumab (95% CI, 67.9%–78.1%), and 64.5% for patients who received chemotherapy alone (95% CI, 58.8%–69.6%).

The phase III AEGEAN trial (NCT03800134) investigated perioperative durvalumab plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with resectable (stage II to IIIB [N2]) NSCLC. Patients received four cycles of treatment every 3 weeks before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. The modified intention-to-treat population (740 patients) included all patients who were randomly assigned, excluding patients with documented EGFR or ALK alterations. The first planned interim analysis occurred with 31.9% data maturity and at a median follow-up of 1 year. The primary end points were EFS and pathological complete response.[14][Level of evidence B1]

Pathological complete response was significantly higher with perioperative durvalumab (17.2%), compared with chemotherapy alone (4.3%, P < .001).

The phase III AEGEAN trial (NCT03800134) investigated perioperative durvalumab plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with resectable (stage II to IIIB [N2]) NSCLC. Patients received four cycles of treatment every 3 weeks before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. The modified intention-to-treat population (740 patients) included all patients who were randomly assigned, excluding patients with documented EGFR or ALK alterations. The first planned interim analysis occurred with 31.9% data maturity and at a median follow-up of 1 year. The primary end points were EFS and pathological complete response.[14][Level of evidence B1]

The EFS and pathological complete response benefit were observed regardless of stage and PD-L1 expression.

The phase III AEGEAN trial (NCT03800134) investigated perioperative durvalumab plus neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with resectable (stage II to IIIB [N2]) NSCLC. Patients received four cycles of treatment every 3 weeks before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. The modified intention-to-treat population (740 patients) included all patients who were randomly assigned, excluding patients with documented EGFR or ALK alterations. The first planned interim analysis occurred with 31.9% data maturity and at a median follow-up of 1 year. The primary end points were EFS and pathological complete response.[14][Level of evidence B1]

The safety profile was consistent with known profiles of durvalumab and chemotherapy.