Are patients with early-stage non-small cell lung cancer receiving timely testing for the ALK rearrangement?

e23276 Background: In the US, standard of care treatment for patients with ALK+ early-stage non-small cell lung cancer (eNSCLC) changed in April 2024, with FDA approval of adjuvant (adj.) alectinib. The ALINA trial demonstrated that alectinib led to superior disease-free survival compared to platinum-based chemotherapy for patients with resected stage Ib-IIIa ALK+ eNSCLC. However, patients can only be treated if ALK+ is identified. Research in other settings has shown that standardized population biomarker testing can significantly lag regulatory approval of targeted therapy. Here, we sought to assess the extent to which patients diagnosed after FDA approval of adj. alectinib were tested for ALK+ in the real-world setting, and further to determine which factors are associated with probability of testing. Methods: We retrospectively analyzed patients with resected stage Ib-IIIa NSCLC diagnosed in the US after approval of adj. alectinib. We used the expanded nationwide de-identified Flatiron Health EHR-derived database, which aggregates data from roughly 280 US cancer clinics (~800 sites of care). Two testing endpoints were considered: (1) ALK testing results (by any modality) within 90 days of diagnosis, and (2) ALK testing results (by any modality) prior to the initiation of any neoadjuvant/adjuvant systemic therapy. The latter endpoint was estimated within the subset of patients with systemic therapy starts. We used logistic regression to assess the association between clinico-demographic characteristics and likelihood of testing. We also compared testing rates with those measured in the period prior to approval of adj. alectinib. Results: We identified 672 patients matching the criteria described above, with diagnosis between April and July 2024. Overall, 60% of patients diagnosed after FDA approval of adj. alectinib underwent ALK testing within 90 days, compared to 34% among patients diagnosed in the five-year period preceding FDA approval of adj. alectinib. Among the 379 patients with confirmed starts of any systemic therapy, only 235 (62%) had known ALK status prior to the initiation of systemic therapy. Black race, receipt of care in an academic (vs. community) setting, and lower socioeconomic status were all associated with lower probability of testing within 90 days. Conclusions: This study showed that ALK testing among eNSCLC patients has increased following FDA approval of adj. alectinib. For many patients systemic therapy is initiated before knowledge of ALK status; such care is sub-optimal because ALK+ is associated with a lack of benefit from immunotherapy. Further, we identified potential emerging signals of disparities in access to ALK testing in eNSCLC in the US. Payers, providers, and other stakeholders should strive to ensure that all patients with stage Ib-IIIa NSCLC are tested for the ALK biomarker early in the treatment journey.