Enhertu posts KRW 7.4 bil in H1 sales without reimb

New ADC drug for HER2-positive breast cancer

Approved in Sep last year, posts sales of KRW 2.2 bil in Q1, KRW 5.2 bil in Q2 this year

Reimbursement listing in slow progress...continues to be non-deliberated by DREC after passing CDDC review

Daiichi Sankyo Korea’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab deruxteca); has raised sales of over KRW 7 billion in H1 this year without reimbursement.

 

According to the market research institution IQVIA on the 31st, Enhertu posted sales of KRW 7.4 billion in H1 this year, making KRW 2.2 billion in Q1 and KRW 5.2 billion in Q2.

 

Even without reimbursement listing, sales of the drug had exceeded KRW 7 billion.

 

This indicates the many breast cancer patients in need of the treatment.

 

The non-reimbursed cost of Enhertu is known to be in the KRW 5 million range per injection.

 

Enhertu is an antibody-drug conjugate (ADC) that was approved by the Ministry of Food and Drug Safety in September last year.

 

It is used to treat HER2-positive breast cancer.

 

More specifically, Enhertu is indicated to treat unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting, and locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

 

Also, in December, the drug’s indication was extended to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

 

However, the drug is making small progress in terms of reimbursement listing.

 

The drug passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, but remains pending thereafter, without being deliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings that followed.

 

The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown.

 

Patients have been long awaiting its reimbursement listing, to the extent that a public petition had been registered on its coverage.

 

The petition was filed in January this year and received 50,000 consents on its need in only 5 days.

 

The agenda was then referred to the National Assembly’s Health and Welfare Committee and started the reimbursement listing process.

 

Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy.

 

Results showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1.

 

The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1.

 

Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1.

 

Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab.

 

Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.