Tagrisso’s expanded indication offers full-cycle treatment for EGFR-mutant NSCLC, but high reimbursement threshold limits access

AstraZeneca’s Tagrisso (osimertinib), a third-generation EGFR-targeted anticancer drug, has become a full-cycle treatment option for EGFR-mutated non-small cell lung cancer (NSCLC), bringing the disease one step closer to a possible cure.

However, it has been criticized that the reimbursement threshold for early-stage patients in Korea is too high for them to receive timely treatment with Tagrisso.

Recently, Tagrisso demonstrated its effectiveness in reducing recurrence in patients with unresectable stage 3 EGFR-mutant NSCLC through the LAURA study. Together with the existing ADAURA study, Tagrisso has proposed a new treatment paradigm for early-stage patients.

In Korea, Tagrisso received an additional indication in December 2024 for "the treatment of patients with unresectable stage III EGFR-mutated (Ex19del, L858R substitution) NSCLC whose disease has not progressed during or after platinum-based chemoradiotherapy," making Tagrisso the only EGFR-targeted anticancer agent available for patients at all stages.

This indication expansion is particularly significant because it provides Tagrisso with a full-cycle treatment strategy for EGFR-mutant NSCLC and brings us one step closer to the ultimate goal of curing lung cancer.

Tagrisso expected to fill treatment gap for unresectable stage 3 patients at high risk of relapse

The LAURA study is a global phase 3 trial comparing Tagrisso to placebo in patients with unresectable stage 3 EGFR-mutant NSCLC whose disease has not progressed during or after platinum-based chemotherapy.

Results showed that Tagrisso treatment reduced the risk of disease progression or death by 84 percent (HR 0.16), with a median progression-free survival (mPFS) of 39.1 months in the Tagrisso arm compared to 5.6 months in the placebo arm.

The study was presented as a Plenary Abstract at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) in June 2024, marking the second consecutive year Tagrisso has been featured on the Plenary podium, following the ADAURA and LAURA studies.

Tagrisso's indication expansion is significant because it fills a treatment gap for patients with unresectable stage 3 lung cancer who are at high risk of recurrence but for whom no other treatment options have been available.

With approximately 20 percent of stage 1, 40 percent of stage 2, and more than 70 percent of stage 3 lung cancer patients experiencing recurrence, even at early stages, there was an urgent need for a treatment option to reduce the risk of recurrence in unresectable stage 3 patients.

In addition, Tagrisso previously demonstrated improved survival in the ADAURA study as postoperative adjuvant therapy for patients with stages 1B through 3A. In addition to the primary endpoint of disease-free survival (DFS), the study also demonstrated an improvement in overall survival (OS), establishing Tagrisso adjuvant therapy as an important treatment strategy to increase the likelihood of a cure.

‘Timely treatment is key’

As such, the importance of "right time" treatment has been emphasized, as Tagrisso has gone beyond simply prolonging survival in stage 4 patients and has shown promise for curing patients in stages 1-3.

“Tagrisso's recent indication additions based on the LAURA study make it a treatment option that can provide personalized care for patients at all stages of EGFR-mutant NSCLC, from early to advanced disease,” said Han Ji-yeon, MD, professor of hematology-oncology at the National Cancer Center. “In particular, Tagrisso's ADAURA study is significant because it raises expectations for the ultimate goal of EGFR-mutant NSCLC treatment: a cure.”

“Timely treatment is crucial in lung cancer, where progression is rapid and the risk of metastasis or recurrence is high,” said Han. “It is important that patients with EGFR-mutant lung cancer do not delay treatment and that the right treatment is timed early to improve survival and realize the possibility of a cure.”

However, Tagrisso adjuvant therapy has not been reviewed for reimbursement in South Korea, three years after the indication was expanded. The reimbursement threshold is too high for Korean patients to receive timely treatment with Tagrisso.

Given that Tagrisso is currently the only targeted therapy option available for patients with stage 1-3 EGFR-mutant NSCLC, it is time to explore ways to improve access to timely treatment for patients, experts said.