AstraZeneca's Top-Selling Cancer Drug Sees Early Unblinding in Key Trial

By Reuters Staff

April 13, 2020

(Reuters) - AstraZeneca Plc said the Phase III ADAURA trial of its top-selling cancer drug Tagrisso (osimertinib), aimed at showing the drug's benefit in the adjuvant treatment of with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumor resection, is being stopped early for "overwhelming efficacy" at the recommendation of an independent data monitoring committee.

José Baselga, executive vice president, Oncology R&D, said the company was thrilled by the recommendation to unblind the trial much earlier than expected "and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer."

The primary endpoint of the Phase III ADAURA trial is disease-free survival. The British drug maker said the data will be presented at a forthcoming medical meeting.

In the experimental arm, patients in more than 20 countries were treated with Tagrisso 80mg once-daily oral tablets for three years or until disease recurrence. Data readout was originally anticipated in 2022.

Tagrisso is already approved in 80 countries for first-line EGFRm advanced NSCLC and in 87 countries for second-line use in patients with EGFR T790M mutation-positive advanced NSCLC.