Leclaza and Tagrisso compete for reimb in the first line

Leclaza’s indication expanded as first-line treatment... company seeks prompt reimbursement for the indication

Tagrisso passes CDDC review after 4 years... is receiving PE evaluations

Leclaza may compete along the same line with Tagrisso if it passes CDDC review in July-Aug,

(From the left) Pic of Leclaza and Tagrisso

Yuhan Corp’s EGFR-targeted anticancer drug ‘Leclaza (lasertinib)’ has been approved as a first-line treatment in Korea and is competing for reimbursement with its competitor ‘Tagrisso (osimertinib).’ As reimbursement review for Tagrisso’s first-line indication is already in progress, Yuhan is also expected to hasten its steps to receive reimbursement for its Leclaza.

 

On June 30th, the Ministry of Food and Drug Safety approved the change in Leclaza’s indication to ‘the treatment of patients with advanced or metastatic non-small-cell lung cancer harboring EGFR mutation exon 19 deletions or exon 21 substitution.’ With the approval, Leclaza, which had been used as a second-line treatment until now, is now available as a first-line treatment in Korea.

 

As a result, 2 third-generation TKIs – Tagrisso and Leclaza – are now available for the treatment of EGFR-mutated NSCLC in the first line.

 

However, as the first-line indication for the drugs is yet to be reimbursed in Korea, the drugs are mainly used as subsequent therapy following initial treatment with first and second-generation drugs.

 

Leclaza PFS data(Data: ESMO Asia)

Results of the Phase III LASER301 trial that was presented in December last year showed that Leclaza achieved its primary endpoint and improved progression-free survival (PFS) over its comparator (gefitinib) by 9.7 months.

 

Also, Leclaza reduced the risk of disease progression and death by 55% compared to the control group (HR=0.45).

 

Also, its benefit was consistently observed in ▲patients with brain metastasis, ▲patients with L858R mutation, and▲ Asians.

 

Although a uniquely high incidence of paresthesia was observed in the Leclaza-treated group, most were mild and manageable.

 

◆Tagrisso and Leclaza compete for first-line reimbursement With the approval, Leclaza is now on a level playing field with Tagrisso.

 

Leclaza quickly closed the gap during the 4 years Tagrisso struggled and failed to pass its first step to receiving reimbursement in the first line.

 

Therefore, how the competition will end will now depend on which drug becomes reimbursed in the first line.

 

In the case of Tagrisso, its adequacy for reimbursement in the first line was finally recognized in March by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) after 5 attempts.

 

AstraZeneca had attempted to pass CDDC review with its global FLAURA trial data that was the basis of Tagrisso’s fist-line indication and the FLAURA China trial data that confirmed an improvement in overall survival (OS) in Asians, to no avail.

 

The CDDC had deemed that the data was not sufficient to recognize the drug’s effect on Asians.

 

The company had strategically narrowed its reimbursement standards, but that attempt was also turned down by the CDDC.

 

The situation turned in favor of Tagrisso at the end of 2022 after large-scale real-world data on Tagrisso’s effect as a first-line treatment in Asia and Europe was released.

 

Analysis of the real-world data of 660 Japanese patients confirmed a progression-free survival of 20.0 months and overall survival of more than 3 years (40.9 months), which was longer than that found in its Phase III clinical trial.

 

Based on the data, the company put an end to Tagrisso’s efficacy controversy in Asia.

 

However, the problem is that the company has only now passed the first step to its reimbursement.

 

Tagrisso’s reimbursement agenda needs to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC) review, drug pricing negotiations with the National Health Insurance Service, and the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee (HIPDC) to complete the reimbursement process in Korea.

 

As a risk-sharing agreement (RSA) drug, Tagrisso must also pass pharmacoeconomic evaluations.

 

HIRA’s statuary evaluation period is set at 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data.

 

In fact, 3 months have passed since Tagrisso passed the CDDC review, but no schedule for the subcommittee for its pharmacoeconomic evaluation has been set yet.

 

Although the statutory period set for the reimbursement process sets the timing for Tagrisso's reimbursement extension at the end of this year, there is a strong possibility that the period will be delayed somewhat.

 

Unlike Tagrisso, Leclaza’s reimbursement agenda is expected to pass CDDC review without difficulty as the drug demonstrated its effectiveness in the Asian subgroup with a hazard ratio of 0.46.

 

The fact that it is the only homegrown new drug is also expected to work in favor of Leclaza.

 

Therefore, if Leclaza passes the CDDC review in July or August, the drug may also be deliberated by DREC with Tagrisso.

 

Yuhan Corp plans to apply for reimbursement in the first line as soon as possible.

 

Also, the company has also prepared an Early Access Program (EAP) that provides Leclaza free of charge until the drug is granted reimbursement.

 

The move shows Yuhan Corp’s confidence that it will be able to rapidly receive reimbursement.

 

Yuhan Corp said, “With Leclaza’s approval, we are pleased to be able to provide a new treatment option for patients with EGFR mutation-positive NSCLC, which is highly prevalent in Korea.

 

We are preparing to apply for the reimbursement extension for Leclaza in the first line and provide our drug for free to the patients until it is reimbursed through our Early Access Program (EAP).”