Medical societies in advanced nations recently recommended AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI) Tagrisso (ingredient: osimertinib) as postoperative adjuvant therapy for early lung cancer,
And that means Korea should revise the related reimbursement criteria and change the diagnostic routine, an expert said.
The American Society of Clinical Oncology (ASCO) updated adjuvant therapy guidelines in early lung cancer in five years, strongly recommending AstraZeneca’s Tagrisso and Roche’s anti-PD-L1 immunotherapy Tecentriq (atezolizumab).
The updated recommendations, made in 2017, were based on the results of the ADAURA study of Tagrisso in 2020 and the IMpower010 study on Tecentriq in 2021.
ASCO made a “strong” recommendation with “high” evidence to use three-year adjuvant Tagrisso for stage 1B non-small cell lung cancer (NSCLC) patients with sensitizing EGFR (Ex19del or L858R) mutations.
Also, for stage 2A-3A patients with sensitizing EGFR mutations, ASCO recommended adjuvant Tagrisso after cisplatin-based chemotherapy, regardless of the PD-L1 status. The evidence quality was “high,” and the strength of recommendation was “strong.”
ASCO renewed the recommendations because Tagrisso as postoperative adjuvant therapy significantly lowered the risk of disease recurrence and death in stage 1B-3A NSCLC patients with EGFR mutations, compared to the placebo, in the ADAURA study.
The additional administration of Tagrisso for three years reduced the risk of relapse and death by 83 percent in stage 2-3A patients who had a high proportion (75 percent) of getting prior adjuvant therapy.
In the entire (stage 1B-3A) patients, including stage 1B patients who had a low proportion (26 percent) of adjuvant therapy, Tagrisso lowered the risk of relapse and death by 80 percent.
Also, ASCO recommended one year or 16 cycles of adjuvant Tecentriq for stage 2-3A patients with PD-L1 expression at 1 percent or more after cisplatin-based chemotherapy except for those with sensitizing EGFR mutations. Again, the evidence quality was “high,” and the strength of recommendation was “strong.”
“ASCO’s new recommendations are meaningful because they can improve the survival rate of early lung cancer patients by actively considering targeted therapy and immunotherapy in postoperative adjuvant therapy,” said professor Lee Sung-yong at the Respiratory and Allergic Medicine Division of Korea University Guro Hospital.
Lee predicted that Tagrisso would change the paradigm of adjuvant therapy in early lung cancer patients.
Just like doctors examine for EGFR mutations to treat advanced or metastatic NSCLC, they will check whether an early lung cancer patient has EGFR mutations, which will become a new diagnostic pattern.
“We can see a clearer role of Tagrisso when we get the overall survival (OS) data from the ADAURA trial, but we can expect that the third-generation EGFR TKI (Tagrisso) can improve survival in EGFR-mutated patients,” Lee said. “Also, in patients without such mutations, we can expect that atezolizumab will contribute to a reduction of relapse and survival improvement.”
Thus, the future diagnostic paradigm of adjuvant therapy will change depending on EGFR mutations, he added.
However, to reflect the latest changes, the local reimbursement and diagnosis should change, Lee emphasized.
First, osimertinib should become reimbursable for EGFR-mutated patients, and for stage 2A-3A patients whose PD-L1 expression is more than 1 percent, atezolizumab should be recognized as postoperative adjuvant therapy, he said.
Although the adjuvant therapy of osimertinib has not yet been covered by health insurance, the use of the drug has been approved by the Ministry of Food and Drug Safety, he went on to say.
“Thus, local treatment guidelines should change so that doctors can conduct an EGFR mutation test routinely in early lung cancer patients, too,” he said.
AstraZeneca agreed that Tagrisso should be covered by health insurance for early lung cancer treatment. Although Tagrisso reimbursement for the first-line treatment of advanced lung cancer is not progressing smoothly, the company could seek adjuvant Tagrisso reimbursement in early lung cancer because it targets complete remission.
An official at AstraZeneca said that before the ASCO’s guideline update, the European Society for Medical Oncology (ESMO) and the U.S. National Comprehensive Cancer Network (NCCN) had already recommended Tagrisso adjuvant therapy.
“As the patient's needs are clear and the academic consensus has been reached, we will prepare to seek insurance benefits for Tagrisso,” the official said.