The Cancer Committee discusses Tagrisso's first-line therapy

Re-application for benefits in the second half of last year, attention to expanding the range of prescriptions for third-generation drugs

Additional submission of FLAURA China data verified by Asians

#Tagrisso, a third-generation lung cancer targeting anticancer drug, is once again discussed at the Cancer Drugs Benefit Appraisal Committee in about a year.

 

According to related industries, discussions on expanding the benefits of first-line therapy for the third-generation epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (Osimertinib) will be held at the Cancer Drugs Benefit Appraisal Committee, which will be held on the 7th.

 

As Leclaza, a drug of the same class, passed the Cancer Drugs Benefit Appraisal Committee within a month after approval, it is noteworthy whether Tagrisso can pass to expand benefits.

 

Tagrisso was added first-line therapy indications in Korea in December 2018 and aimed to expand benefits in 2019, but in October of the same year, a Phase 3 FLAURA study that confirmed overall survival (OS) in first-line therapy at the Cancer Drugs Benefit Appraisal Committee.

 

It was put on hold that it would have to wait for the full data of the company to be released.

 

Later, along with the additional submission of the full data of the FLAURA study, they expressed their intention to accept most of the fiscal allocation proposals proposed by the government, but the members (specialists) objected that there was a problem with the clinical usefulness.

 

Last May, the expansion of the benefits of first-line therapy was rejected.

 

AstraZeneca's FLAURA China study, which was poster published last year at the online European Society for Medical Oncology (ESMO), added the evidence for confirming OS in Asians.

 

The reason why Tagrisso's first-line therapy benefit extension was rejected was an Asian sub-analysis of FLAURA.

 

Through the study, Tagrisso's OS was 38.6 months, demonstrating 6.8 months improvement compared to the first-generation drugs Iressa (Gefitinib) and Tarceva (Erlotinib).

 

It is the first among EGFR TKIs, and it is encouraging considering that it has admitted the cross-over prescription of patients with confirmed T790M mutations in the first-generation drugs for research ethics.

 

However, it was the Hazard Ratio (HR) of the sub-analysis for Asians.

 

Tagrisso's HR for Asians was only 0.995.

 

The value of 0.995 means that the gap is 0.005 based on 1, meaning that there is no difference from the control group.

 

Based on this, an opinion was raised in academia that Tagrisso's OS is unreliable in Asians to which Koreans belong, and it had a dominant effect on the results of the Cancer Drugs Benefit Appraisal Committee.

 

It is noteworthy what the results of Tagrisso, which added a study on Chinese people, will be produced.

 

Meanwhile, in the FLAURA Chin study using a Chinese cohort, a total of 71 patients were assigned to the Tagrisso group and 65 patients were assigned to the control group.

 

In particular, if the patients in the control group progressed to T790m positive, they could switch to Tagrisso and receive secondary treatment, and 22 out of 65 patients in the control group continued treatment with Tagrisso.

 

As a result, the median OS of the Tagrisso group was 33.1 months, which was 7.4 months longer than 25.7 months of the control group, and the risk of death was reduced by 15.2%.