[Reporter's view] When will Enhertu's benefit be available?

Daiichi Sankyo and AstraZeneca's Enhertu are continuing their unstoppable moves.

 

Enhertu, which has achieved remarkable results in breast cancer, has expanded the types of carcinoma to include gastric cancer and lung cancer and is expected to be used in a number of solid cancers that show HER2 expression, such as cervical cancer, endometrial cancer, and ovarian cancer.

 

Several ADCs have been approved, but none have been as scalable as Enhertu.

 

Indeed, Enhertu is writing ADC history.

 

The phase 2 results for Enhertu announced at ASCO 2023 in June were very positive.

 

Although it was not at a stage that deserved a standing ovation like last year's announcement of low-expression breast cancer of HER2, this announcement raises the possibility that Enhertu will be reborn as an anti-cancer drug regardless of cancer type.

 

The Enhertu DESTINY-PanTumor02 clinical trial announced at ASCO was a study that examined the effects of Enhertu by forming a cohort of cervical cancer, endometrial cancer, ovarian cancer, bile duct cancer, pancreatic cancer, bladder cancer, and other solid cancers without a control group.

 

For each cohort, 40 patients were recruited and Enhertu was administered.

 

ORR was set as the primary evaluation index, and DOR, DCR, PFS, OS, and safety were established as secondary evaluation indexes.

 

What is noteworthy is the response rate that Enhertu showed.

 

It recorded a response rate of 50% or more in cervical cancer and endometrial cancer.

 

In particular, the response rate for endometrial cancer reached 57.5%.

 

Seven out of 40 endometrial cancer patients (17.5%) showed complete remission (CR) and 16 (40%) showed partial response (PR).

 

At 12 weeks, 80% (32 patients) of endometrial cancer patients had their disease under control.

 

In conclusion, Enhertu recorded a response rate of 30% or more in all cancer types studied, except for pancreatic cancer, which had a response rate of only 4%, and biliary tract cancer, which had a relatively low response rate of 22%.

 

About a month later, on the 27th, additional analysis results of DESTINY-PanTumor02 were announced.

 

In summary, Enhertu demonstrated improvement in PFS and OS, which were set as secondary evaluation indicators.

 

Follow-up clinical trials should be supported, but it is clear that Enhertu is rapidly taking off as an anti-cancer drug regardless of cancer type.

 

Domestic patients looking at Enhertu's rapid development were very distressed.

 

Although approved, access to treatment is low due to non-reimbursement.

 

Enhertu is an oasis for patients not only in breast cancer but also in gastric cancer where new drug options are limited.

 

Daiichi Sankyo's commitment to Enhertu's fast benefit was also quite large.

 

It is known that several measures were prepared, such as offering the drug price at the lowest price in the world and considering additional RSA.

 

Patients urged Enhertu's speedy reimbursement listing.

 

The national consent petition for this was so supportive that it obtained the consent of 50,000 people last February.

 

The health authorities seem to be paying attention to Enhertu's benefit, as if conscious of public opinion.

 

It can be seen from the fact that even when the review committee was first eliminated, it was concluded through a re-examination rather than not setting a standard.

 

Considering the time it takes for a new drug to be registered for reimbursement in Korea, Enhertu's reimbursement process is fast.

 

Currently, Enhertu has passed the cancer disease review committee after re-examination and is undergoing a PE review.

 

However, it is unclear when it will be presented to the pharmaceutical reimbursement evaluation committee, which is in the final stage.

 

Patients are anxiously awaiting news of the assumption.

 

In about two months, it will be a year since Enhertu was approved in Korea.

 

Even after passing the Drug Evaluation Committee, all procedures for insurance coverage are completed only after drug price negotiations with the NHIS and the health insurance policy deliberation committee of the Ministry of Health and Welfare.

 

By the end of the year, after Enhertu's first global launch, it will take 48 months to receive benefits in Korea, exceeding the OECD average of 45 months.

 

We hope that patients' wait for Enhertu will not be too long.