FDA grants priority review to Tagrisso for lung cancer subset
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The FDA granted priority review to osimertinib for adjuvant treatment of certain patients with early-stage non-small cell lung cancer.
The designation applies to use of the agent by patients with stage IB, stage II or stage IIIA EGFR-mutated NSCLC who underwent complete tumor resection with curative intent.
The FDA granted breakthrough therapy designation to osimertinib (Tagrisso, AstraZeneca) — a third-generation, irreversible EGFR-directed tyrosine kinase inhibitor — for this indication in July. The agency is expected to make a decision on approval in the first quarter of 2021.
Approximately one-third of patients with NSCLC present with early-stage disease, defined as stage I through stage IIIA. Surgery is the primary treatment for these patients. Adjuvant chemotherapy is standard for those with stage II or stage III disease, as well as for select patients with stage IB disease.
Despite these treatments, 5-year recurrence rates range from 45% for patients with stage IB disease to 76% for those with stage III disease.
The FDA based the priority review on results of the randomized phase 3 ADAURA trial, which included 682 patients with early-stage EGFR-mutated NSCLC.
Researchers randomly assigned 339 patients to osimertinib dosed at 80 mg once daily. The other 343 patients received placebo. Treatment continued for 3 years or until disease recurrence.
DFS among patients with stage II or stage IIIA disease served as the primary endpoint. DFS in the entire study population served as a key secondary endpoint.
As Healio previously reported, results of an interim analysis presented during the ASCO20 Virtual Scientific Program showed osimertinib significantly prolonged DFS among those with stage II to stage IIIA disease (median, not reached vs. 20.4 months; HR = 0.17; 95% CI, 0.12-0.23), as well as in the overall study population (median, not reached vs. 28.1 months; HR = 0.21; 95% CI, 0.16-0.28).
Osimertinib-treated patients were more likely than those assigned placebo to be disease free at 2 years (stage II to stage IIIA disease, 90% vs. 44%; overall population, 89% vs. 53%).
Updated data presented during ESMO Virtual Congress 2020 showed osimertinib induced clinically meaningful reductions in central nervous system disease recurrence and death.
“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk [for] recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a company-issued press release. “This expedited review underscores the unprecedented DFS benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible.”
The ADAURA trial will continue so investigators can assess OS.
Osimertinib already is approved in the United States for first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC, as well as for treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
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