The Phase III ADAURA trial, assessing Tagrisso (osimertinib) in the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy, according to a press release from AstraZeneca (AZ).

Tagrisso is the top-selling brand in a resurgent AZ oncology portfolio, and this announcement will lead to increased revenues for AZ in the highly lucrative NSCLC market. This announcement comes off the back of positive data from the Phase III FLAURA trial in August demonstrating the superiority of Tagrisso over Iressa and Tarceva, both of which were considered the standard of care in the first-line advanced EGFR-mutated NSCLC setting. Within one year, Tagrisso has secured its position as the first-line standard of care in the advanced setting and the ADAURA trial now allows further commercial opportunity via a label expansion in the adjuvant setting. Thus, Tagrisso will likely be more widely adopted in the clinic in 2020 in the advanced setting and worldwide revenues of $3.2B in 2019 will be significantly exceeded in 2020. This is bolstered by the expectation that the ADAURA trial will provide the basis for an imminent regulatory filing for use in the adjuvant setting. Tagrisso is set to be the first EGFR inhibitor to demonstrate a clinically meaningful benefit in this setting.

Gaining label expansions in earlier lines of therapy is a commonly employed R&D strategy in the oncology sector to increase market share and revenues for a drug with proven efficacy in the advanced setting. In addition to widening the eligible patient population, patients will also receive Tagrisso for up to three years, providing a solid revenue stream for AstraZeneca. Tagrisso, a third-generation EGFR inhibitor, benefits from treating patients with both EGFR-sensitizing and EGFR T790M-resistant mutations and has demonstrable clinical activity against central nervous system metastases. Despite the success of Tagrisso, the National Institute for Health and Care Excellence (NICE) recently rejected recommending the use of Tagrisso in the NHS due to its high cost, immature overall survival data, and the lack of a comparator arm in the trial for Giotrif (afatinib), which would typically be prescribed to this patient population in the UK. AstraZeneca has yet to release the ADAURA data and the regulatory bodies will be required to reassess the cost-effectiveness of Tagrisso in the adjuvant setting. GlobalData expects that Tagrisso may have a greater chance for approval in this setting given its potential first-in-class status and a lack of competitors in this clinical setting, combined with a likely discount to alleviate concerns around pricing.