On the 19th, AstraZeneca Korea held an online press conference to commemorate the 5th anniversary of the domestic release and acquisition of indications for adjuvant therapy after surgery of Tagriso (ingredient name osimertinib), a targeted treatment for non-small cell lung cancer with a 3rd generation EGFR mutation.
The conference was held under the theme of’Tagriso Leading the Paradigm of EGFR Mutated Non-Small Cell Lung Cancer’, and the National Cancer Center Lung Cancer Center Chief Researcher Han Ji-yeon and Yonsei University Oncology Professor Hong Min-hee presented as speakers.
One of the best researchers introduced the therapeutic value of Tagriso, the first third-generation targeted therapy targeting EGFR, one of the mutations common in patients with non-small cell lung cancer in Korea, through a major landmark study.
Among them, the median progression-free survival (PFS) is more than twice as high as that of standard therapy (10.1 months in the Tagriso group vs. 4.4 months in the standard therapy group), along with the AURA3 phase 3 study that changed the paradigm of advanced non-small cell lung cancer treatment. It highlighted the value of the FLAURA Phase 3 study, which presented the therapeutic benefits of Tagriso to more patients as a first-line treatment even without confirmation of the T790M mutation in the car.
In particular, in FLAURA, Tagriso extended the median PFS by 8.7 months (18.9 months in the Tagriso group, 10.2 months in the standard therapy group), followed by a significant median overall survival (OS) of 3 years or more even with cross-administration allowed in the standard therapy group. (Tagriso group 38.6 months, standard therapy group 31.8 months).
One Chief Researcher said, “The average progression-free survival period of the first and second generation EGFR target therapies is about 8 to 14 months, and the treatment effect is inferior to brain metastases accompanied by 19 to 24% of EGFR mutations in non-small cell lung cancer.” Tagriso has significantly improved progression-free survival compared to existing EGFR target therapies, and has become one of the best treatment options for EGFR mutant non-small cell lung cancer, with superior progression-free survival regardless of the presence or absence of central nervous system metastasis. “There is no reason not to use Tagriso first in lung cancer with a high prognosis and poor prognosis.”
Professor Hong introduced the major achievements of ADAURA, Tagriso’s latest clinical trial. This study is a phase 3 study that was the basis for obtaining the indication for adjuvant therapy after surgery in patients with early stage (1B-3A) lung cancer by Tagriso as the first EGFR targeted therapy. At 24 months, Disease Free Survival (DFS) At baseline, the risk of disease recurrence or death in patients with stage 2-3A was reduced by 83% compared to placebo in the Tagriso group. In the total patient group, 89% of the Tagriso group survived without recurrence of cancer, while 52% of the placebo group. Tagriso showed consistent disease-free survival results regardless of stage and previous adjuvant chemotherapy.
Professor Hong said, “Even in early stage lung cancer, recurrence occurs in more than 50% within 5 years after tumor resection. In addition, in patients with partial IB, stage 2, and 3, the 5 year overall survival improvement effect of adjuvant chemotherapy is less than 5% compared to those who do not. “Tagriso has shown remarkable results in reducing the risk of recurrence or death by 80% compared to placebo in early stage (1B, 2, 3A) patients who underwent complete tumor resection through a phase 3 clinical trial. “The ASCO) Independent Data Monitoring Committee recommended early release of clinical data. Tagriso is the first case to show the potential of EGFR targeted therapy in postoperative adjuvant therapy, which will open new horizons in the treatment of lung cancer in the future.”
Currently, the U.S. Comprehensive Cancer Network (NCCN) guidelines recommend Tagriso as the only preferred therapy at the highest recommended level (category 1) in the first-line treatment of EGFR mutant non-small cell lung cancer patients, and as category 1 in the second-line treatment. As an adjuvant therapy for this possible early stage non-small cell lung cancer, chemotherapy and tagriso therapy are recommended.
“AstraZeneca has been striving to provide optimal treatment options for lung cancer patients from the first generation EGFR target therapy Iressa to the third generation Tagriso,” said Myeong-jin, executive director of the Korea AstraZeneca anticancer drug division. With the 5th anniversary, we will strive to improve patient accessibility to deliver the clinical value of Tagriso to more patients, as a significant year in acquiring a new indication of postoperative adjuvant therapy that can give hope of cure to lung cancer patients. “He said.