At the 31 May to 4 June, 2024, primary results were presented for the that investigated ’s for stage III epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). The patients evaluated were ineligible for resection and had completed chemoradiotherapy without progression. The study sought to determine if Tagrisso, a 3rd generation tyrosine kinase inhibitor (TKI), the standard of care (SOC) adjuvant therapy for resectable EGFRm NSCLC, can also become a SOC for this population.
Currently, AstraZeneca’s is the SOC for this patient segment, but studies have shown that administering immunotherapy to patients with EGFRm is associated with very low response rates. If the investigators chose Imfinzi as the control, upon progression, patients would be forced to wait several months before receiving Tagrisso, as the overlap between the two leads to toxicities. Using platinum-based chemotherapy as the control allowed patients to crossover to the experimental arm, 81% of whom did, with limited toxicities and without the lag time required had they been on immunotherapy.
Tagrisso impressively beat the placebo in progression-free survival (PFS), the study’s primary endpoint (39.1 months vs. 5.
6) (hazard ratio [HR], 0.16). At 12 months, 74% of patients on Tagrisso had a PFS, while only 22% achieved this on the placebo.
The PFS benefit was observed across subgroups such as age, sex, stage (IIIa–IIIc), and EGFRm. The objective response rate was almost two-fold.