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Enhertu treats advanced gastric cancer with 41% less on mortality rate.
The targeted drug Enhertu was approved to treat advanced gastric cancer, and the mortality rate dropped by 41%.
Recently, the highly anticipated HER2 targeting antibody conjugated drug Enhertu (DS-8201) has been approved by the US FDA as a new indication for the treatment of HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma patient.
These patients had previously been treated with trastuzumab.
The results of clinical trials showed that the objective response rate (ORR) and overall survival (OS) of patients treated with Enhertu were significantly improved statistically.
This is the first ADC used to target HER2+ advanced gastric cancer patients in more than a decade.
In December 2019, Enhertu was approved by the FDA to treat patients with HER2-positive metastatic breast cancer, bringing new treatment options to such cancer patients.
▌The silent “killer”: stomach cancer
Gastric cancer is the fifth most common cancer in the world and the third leading cause of cancer deaths. In 2020, there will be approximately 1 million newly confirmed cases worldwide and more than 768,000 deaths.
In China, gastric cancer is the second largest type of cancer after lung cancer, accounting for 44% and 50% of the world’s deaths, respectively. Among them, about 1/5 of gastric cancer patients are positive for HER2 expression.
HER2 is a tyrosine kinase receptor growth promoting protein that is expressed on the surface of many types of tumors, including breast cancer, gastric cancer, lung cancer and colorectal cancer. HER2 overexpression is usually associated with aggressive disease and poor prognosis.
Stomach cancer often comes silently, and many people are diagnosed as late. Even if it is diagnosed early, the survival rate is not high. The five-year survival rate for metastatic gastric cancer is only 5%.
Currently, the first-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab.
However, for patients with HER2-positive metastatic gastric cancer whose disease is still progressing after first-line treatment, trastuzumab has not shown any further benefits.
The approval of Enhertu has given such patients new options for targeted therapy.
▌Antibody conjugate: Enhertu
Enhertu is an antibody conjugate (ADC) targeting HER2. It uses a unique ADC technology to combine the humanized monoclonal antibody trastuzumab targeting HER2 with a new topology through a 4-peptide linker. The isomerase 1 inhibitor Exatecan (Isatecan) derivatives are linked together to target cancer cells and deliver drugs to the inside of the cells.
Compared with conventional chemotherapy, these new drugs can reduce the side effects of chemotherapy drugs. Moreover, the drug is also being studied to treat a variety of cancers that express HER2, including breast cancer, gastric cancer, NSCLC, colorectal cancer, and patients with low HER2 expression.
In September 2020, Enhertu was approved by the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of HER2-positive, unresectable advanced or recurrent gastric cancer patients.
Enhertu was awarded the Orphan Drug Designation (ODD) in the United States for the treatment of patients with metastatic gastric cancer and gastroesophageal junction cancer.
In addition, the current global clinical trials on Enhertu are currently underway, mainly to evaluate the efficacy and efficacy of the drug in combination with single drugs or with immune checkpoint inhibitors in HER2-positive non-small cell lung cancer, gastric cancer, colorectal cancer and other cancers. safety.
In May last year, Enhertu also won the FDA’s breakthrough therapy designation for the treatment of patients with metastatic non-small cell lung cancer, these patients have tumors with HER2 mutations and the disease is still progressing after platinum-based chemotherapy.
▌The mortality rate has dropped by 41%, and the remission rate has increased by more than 3 times!
This FDA approval is based on the positive results of the randomized, pivotal Phase II DESTINY-Gastric 01 trial.
The study evaluated the safety and effectiveness of Enhertu in 188 patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma from Japan and South Korea.
The tumors of these patients were HER2-positive, and they still progressed after treatment with two or more regimens including fluoropyrimidine (5-FU), platinum-based chemotherapy and trastuzumab.
The results of the trial have been published at the 2020 American Society of Clinical Oncology (ASCO) meeting and published in the New England Journal of Medicine.
The results show that:
1. In the interim analysis, compared with patients in the chemotherapy (paclitaxel or irinotecan monotherapy) group, the death risk of patients in the Enhertu treatment group was reduced by 41%; the median overall survival of the treatment group was 12.5 months, And chemotherapy is 8.4 months
2. The objective remission rate of Enhertu treatment group was 40.5%, while that of chemotherapy group was 11.3%. The objective remission rate was increased by more than 3 times!
3. Compared with the chemotherapy group, the median duration of response (DoR) in the Enhertu treatment group was 11.3 months VS 3.9 months.
4. The median progression-free survival (PFS) of the Enhertu group was 5.6 months, while that of chemotherapy was 3.5 months (HR = 0.47).
Enhertu is the first antibody-conjugated drug approved by the FDA for the treatment of patients with metastatic gastric cancer.
Compared with chemotherapy, the drug has increased the survival of patients by 41% and the remission rate by more than 3 times.
This not only represents a major progress in the treatment of this refractory disease, but also is expected to redefine the first-line standard treatment for such patients.
However, this trial found that a small number of patients (10%) developed interstitial lung disease and embryofetal toxicity when treated with the new drug.
For this reason, Dr. Ian Chau, a gastrointestinal cancer expert of the Good Doctor Medical Network, the American Society of Clinical Oncology (2019·ASCO) Education Committee, and the ESMO Scientific Committee’s gastrointestinal cancer director, said:
“Although these data are of great significance to Chinese patients, it means that more Chinese gastric cancer patients are expected to use this drug. However, patients need to consult more professional doctors before using new drugs.”
Enhertu treats advanced gastric cancer with 41% less on mortality rate
(source:chinanet, reference only)