NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Monday recommended approval of AstraZeneca's tyrosine kinase inhibitor Tagrisso (osimertinib) as a treatment for patients with advanced, unresectable non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, who have not progressed during or after platinum-based chemoradiation therapy.
The committee based its recommendation on data from the Phase III LAURA trial, in which treatment with Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. In the trial, patients on Tagrisso had a median progression-free survival of 39.1 months versus 5.6 months for those on placebo. Overall survival results were immature at the time of analysis.
To be eligible for the trial, patients had to test positive for an EGFR exon 19 deletion or exon 21 L858R substitution either alone or in combination with other EGFR mutations by Roche's Cobas EGFR Mutation Test v2 or the FoundationOne CDx test. Patients in the trial also must not have received prior EGFR inhibitors.
EGFR-mutated disease accounts for 10 percent to 15 percent of all NSCLC in Europe, and among those patients, 1 in 5 will have an unresectable tumor.
If the European Commission takes the CHMP's recommendation and decides to approve Tagrisso in this setting, it will be the first targeted therapy for European patients with unresectable EGFR-mutated lung cancer. This group includes patients with tumors that are not metastatic but are unresectable for reasons such as organ involvement or extensive lymph node involvement. The US Food and Drug Administration approved Tagrisso in this setting in September.
"Today's news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting," Susan Galbraith, AstraZeneca's executive VP of oncology R&D, said in a statement. "Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."
Tagrisso is already approved as a first-line treatment for metastatic EGFR-mutated NSCLC and as a later-line therapy for metastatic EGFR T790M-mutated NSCLC in the US, EU, and other countries. In earlier-stage EGFR-mutated NSCLC, the drug is approved for adjuvant treatment after tumor resection, and in locally advanced or metastatic EGFR-mutated NSCLC, Tagrisso is approved in combination with chemotherapy.