Osimertinib (for patients with EGFR variants)

The phase III, double-blind, placebo-controlled LAURA trial (NCT03521154) included patients with unresectable stage III NSCLC and EGFR variants. Patients had not progressed during or after definitive chemoradiation therapy. A total of 216 patients who had undergone chemoradiation therapy were randomly assigned to receive either osimertinib (n = 143) or placebo (n = 73). The primary end point was PFS as assessed by blinded independent central review.[48]

The phase III, double-blind, placebo-controlled LAURA trial (NCT03521154) included patients with unresectable stage III NSCLC and EGFR variants. Patients had not progressed during or after definitive chemoradiation therapy. A total of 216 patients who had undergone chemoradiation therapy were randomly assigned to receive either osimertinib (n = 143) or placebo (n = 73). The primary end point was PFS as assessed by blinded independent central review.[48]

The median PFS was 39.1 months with osimertinib and 5.6 months with placebo (HRdisease progression or death, 0.16; 95% CI, 0.10–0.24; P < .001).

The phase III, double-blind, placebo-controlled LAURA trial (NCT03521154) included patients with unresectable stage III NSCLC and EGFR variants. Patients had not progressed during or after definitive chemoradiation therapy. A total of 216 patients who had undergone chemoradiation therapy were randomly assigned to receive either osimertinib (n = 143) or placebo (n = 73). The primary end point was PFS as assessed by blinded independent central review.[48]

At 36 months, the OS rate was 84% for patients in the osimertinib group (95% CI, 75%–89%) and 74% for patients in the placebo group (95% CI, 57%–85%) (HRdeath, 0.81; 95% CI, 0.42–1.56; P = .53) (at 20% data maturity).[48][Level of evidence A1]

The phase III, double-blind, placebo-controlled LAURA trial (NCT03521154) included patients with unresectable stage III NSCLC and EGFR variants. Patients had not progressed during or after definitive chemoradiation therapy. A total of 216 patients who had undergone chemoradiation therapy were randomly assigned to receive either osimertinib (n = 143) or placebo (n = 73). The primary end point was PFS as assessed by blinded independent central review.[48]

Grade 3 or higher adverse events occurred in 35% of patients in the osimertinib group and 12% of patients in the placebo group. Radiation pneumonitis was reported in 48% of patients in the osimertinib group and 38% of patients in the placebo group.