Next-Generation ADC Enhertu launches in Korea

Daiichi Sankyo and AZ Joint New Drug Enhertu launches this month

Excellent efficacy compared to Kadcyla

Expect additional indications to be expanded

Enhertu, which Korean breast cancer patients urged for quick permission last year, was released in Korea this month.

 

Analysts say that it will change the paradigm of secondary treatment for HER2-positive breast cancer with a superior effect compared to existing treatments.

 

Daiichi Sankyo held a press conference at the Westin Chosun Hotel on the 12th to commemorate the launch of the ADC (antibody-drug conjugation) new drug Enhertu in Korea.

 

Enhertu is an anticancer new drug approved by the Ministry of Food and Drug Safety in September last year.

 

It can be used for HER2-positive breast cancer (secondary) and stomach cancer (third).

 

Park Yeon-hee, Professor of Hematology and Oncology at Samsung Medical Center

Enhertu is a next-generation ADC jointly developed by AstraZeneca and Daiichi Sankyo.

 

ADC is a drug made by connecting "Antibody" that binds to a specific target antigen on the surface of cancer cells and a "Payload" that has the function of apoptosis with "Linker." It is a drug that selectively acts only on cancer cells to increase treatment effects and minimize side effects.

 

Existing ADCs have caused tumor resistance for various reasons, resulting in some poor efficacy.

 

Enhertu was developed to compensate for these shortcomings and provide optimal anti-tumor effects.

 

Drugs with a new mechanism of action were applied, and a high and uniform drug and antibody ratio was set.

 

◆"The breast cancer data is amazing"…Expected to expand the indication Park Yeon-hee, a professor of hemato-oncology at Samsung Medical Center, who was the speaker at the meeting, introduced Enhertu's major data and welcomed it, saying, "I'm happy to release Enhertu in Korea, which has proven excellent effects in breast cancer clinical trials." Major breast cancer clinical studies in Enhertu include DESTINY-Breast01 and Breast03.

 

The Breast01 study measured the effectiveness and safety of Enhertu in tertiary or higher patients with extensive treatment.

 

The Breast03 study is a phase 3 clinical trial compared to Kadcylla (T-DM1) when Enhertu was used as a secondary treatment.

 

As a result of the final updated Breast01 study in March 2021, N Hutu achieved the first evaluation variable with an objective response rate (ORR) of 62%.

 

The median reaction duration (mDOR) was 18.2 months, the median progression duration (mPFS) was 19.4 months, and the median total survival period (mOS) was 29.1 months, respectively.

 

Enhertu

Professor Park said, "In the clinical trial, Enhertu recorded a high number of 19.4 months of PFS.

 

"OS also showed 29.1 months even though there was no drug available after this," he explained.

 

Enhertu also demonstrated excellent effectiveness in direct comparison with the first-generation ADC treatment Kadcylla.

 

As a result of the Breast03 study, Enhertu reduced the risk of disease progression or death by 72% compared to Kadcyla by 34.1% with a progression-free survival rate of 75.8% at 12 months.

 

Kadcyla's mPFS was 6.8 months, while Enhertu did not reach the evaluation value.

 

Professor Park also expressed high expectations for Enhertu's additional indications.

 

HER2 is low-expression breast cancer.

 

These patients account for half of breast cancer patients, but they are not suitable to use existing HER2-targeted treatments, which is an area with high unmet demand.

 

In a clinical trial announced last year, Enhertu first introduced it in the area of HER2 underexpression by reducing the risk of disease progression or death by 50% compared to the chemotherapy group.

 

Currently, it has acquired an American indication.

 

Professor Park said, "I personally have high expectations for HER2 low-expression breast cancer indications," and added, "I hope the expansion of domestic indications will not be delayed further." ◆"Highly toxic but manageable, Enhertu's benefit should be applied" Enhertu has a high risk of side effects as much as its excellent effect.

 

The most common adverse event in the Breast03 study was interstitial lung disease (ILD), which was cited as the most cautious side effect when using Enhertu.

 

The rate of epileptic lung disease in the Enhertu group was 10.5%, which was higher than that of the Kadcylla group at 1.9%.

 

Professor Park said, "It is true that it is more toxic than conventional drugs," but added, "But it can be managed sufficiently by dose control." He then said, "Fatal side effects were mainly found in Japanese patients, and I don't think this case can be expanded to the entire Asian region." Side effects are something to be careful about, but the prognosis varies depending on how a specialist manages them.

 

"From my experience, I think it is manageable," he added.

 

Professor Park urged Enhertu to register his benefit quickly.

 

Professor Park stressed, "At least the indication received now should be covered by insurance benefits as soon as possible." Daiichi Sankyo is known to have applied for a salary registration for Enhertu breast cancer and gastric cancer on December 28 last year.

 

The HIRA is awaiting the introduction of the Cancer Disease Review Committee.

 

Kang Bo-sung, head of the marketing division of Daiichi Sankyo's anti-cancer drug division, replied, "We will actively discuss with health authorities to register our quick benefit."