Tagrisso (osimertinib), a targeted therapy, has received approval for treating patients with unresectable stage 3 EGFR-mutated (Ex19del, L858R substitution) non-small cell lung cancer (NSCLC) whose disease has not progressed during or after platinum-based chemotherapy and radiation therapy for which there are no targeted therapy options.

AstraZeneca Korea said it received an expanded indication from the Ministry of Food and Drug Safety (MFDS) for Tagrisso to treat EGFR-mutant NSCLC last Friday.

That allows Tagrisso monotherapy to be used for treating patients with unresectable locally advanced NSCLC who have an EGFR exon 19 deletion or exon 21 (L858R) substitution and whose disease has not progressed during or after platinum-based chemotherapy and radiotherapy.

In addition, Targriso is approved in Korea for the first-line treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 substitution.

ㆍ For combination with pemetrexed and platinum-based chemotherapy in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or exon 21 substitutions.

ㆍ For combination with pemetrexed and platinum-based chemotherapy in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or exon 21 substitution.

ㆍ For treating patients previously treated with an EGFR- TKI in treating patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have been previously treated with an EGFR- TKI.

ㆍ For adjuvant treatment after complete tumor resection in patients with EGFR exon 19 deletion or exon 21 substitution mutated NSCLC, it is the broadest indication for a targeted therapy in EGFR-mutated NSCLC.

The study (LAURA) that supported this indication expansion was a randomized, double-blind, placebo-controlled, multicenter, global phase 3 trial in patients with unresectable stage 3 EGFR-mutant NSCLC whose disease had not progressed after platinum-based chemotherapy and radiation therapy.

Results showed that Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. Median progression-free survival (mPFS) in the Tagrisso arm was 39.1 months, 33.5 months longer than placebo (5.6 months). In addition, safety and tolerability were similar to the safety profile of each prior treatment, with no new safety concerns identified.

“The LAURA trial demonstrated a progression-free survival of 39.1 months in the Tagrisso arm, confirming a survival benefit of more than three years,” said Professor Kim Hye-ryun of the Department of Medical Oncology at Severance Hospital. “With this approval, patients with unresectable stage 3 EGFR-mutant NSCLC who have not had a targeted therapy option before can benefit from Tagrisso. The drug sets a new standard for treating unresectable stage 3 EGFR-mutant NSCLC.”

Lim Jae-yun, executive vice president for medical affairs at AstraZeneca Korea, said, “This indication expansion allows patients with all stages of EGFR-mutant NSCLC to benefit from Targriso. It will further solidify Tagrisso's value as a backbone treatment for EGFR-mutant NSCLC. We will continue to build on Tagrisso's innovative therapeutic value to improve survival and quality of life for patients with EGFR-mutant NSCLC.”