AstraZeneca said Friday that the company has confirmed its non-small cell lung cancer (NSCLC) therapy, Tagrisso, significantly increased survival rate while lowering central nervous system metastasis in phase 3 studies.

Tagrisso showed progression-free survival about twice longer than standard therapy as the third-generation drug targeting epidermal growth factor receptor (EGFR) mutations in NSCLC patients, said Han Ji-youn, a top oncology researcher at the National Cancer Center. 

Professor Hong Min-hee of Yonsei University College of Medicine says Tagrisso has become the first EGFR mutation therapy to win approval as postoperative adjuvant treatment for early-stage lung cancer patients during a news conference on Friday.
Professor Hong Min-hee of Yonsei University College of Medicine says Tagrisso has become the first EGFR mutation therapy to win approval as postoperative adjuvant treatment for early-stage lung cancer patients during a news conference on Friday.

In addition to the AURA3 phase 3 clinical trial, which changed the treatment paradigm for advanced NSCLC, the company also confirmed that its lung cancer drug provided therapeutic options for patients without checking T790M mutation in the phase 3 FLAURA study.

In the FLAURA study, Tagrisso showed a median PFS of 18.9 months, up 8.7 months from standard treatments. It also had significant overall survival in patients who switched drugs after three years.

Hong Min-hee, an oncology professor at Yonsei University College of Medicine, also said that Tagrisso became the first therapy targeting EGFR mutation to receive approval as postoperative adjuvant treatment for lung cancer patients in between 1b to 3a stages, which reduced recurrence or mortality by 83 percent than placebo.

According to Professor Hong, about 50 percent of NSCLC patients experience a recurrence in five years after having receiving tumor resection.

“Tagrisso reduced the risk of recurrence or death by 80 percent compared to placebo in early-stage NSCLC patients who had complete tumor resection in phase 3 clinical trials, and the American Society of Clinical Oncology recommended the company to release the clinical data early,” Hong said.

Han, the NCC researcher, also said, “The average survival period of NSCLC patients without progression treated with first and second-generation EGFR therapies is about eight to 14 months, and these drugs demonstrate less efficacy in 19 to 24 percent of patients who already have brain metastases.”

Tagrisso has significantly improved progression-free survival compared to existing EGFR target therapies. It has become one of the best treatments for NSCLC with EGFR mutations, with superior progression-free survival regardless of central nervous system metastasis, Han added.

“AstraZeneca has been striving to provide optimal treatment options for lung cancer patients from Iresa, the first-generation EGFR target therapy, to Tagriso, the third-generation,” she said.

Myeong Jin, managing director of the oncology business unit at AstraZeneca, noted that this year marks the fifth anniversary of launching Tagrisso in Korea.

“It came as a meaningful year as the company could expand the indication of the drug as a postoperative adjuvant therapy for complete recovery of NSCLC patients,” Myeong said.

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