Drug Shows Breakthrough Results To Extend Life Of Hard-To-Treat Breast Cancer



New data released on Saturday at the 2021 European Society for Medical Oncology conference is sparking excitement among those looking to tackle some of the most difficult forms of breast cancer.

The researchers found that the use of the antibody conjugate drug ENHERTU to treat the currently incurable HER-2-positive breast cancer was significantly more effective in shrinking the tumor size and keeping the patient alive longer without progression. disease than the current TDM1 standard of care.

ENHERTU was found to be twice as effective as TDM1, the standard drug, in completely controlling disease in this trial. Both drugs are given intravenously and both are antibody-drug conjugate drugs, but ENHERTU is designed differently, which probably explains the improved results in some people.

“I am really excited about the ENHERTU data, which shows better survival rate than TDM1,” said Dr Jame Abraham, chairman of the department of hematology and oncology at the Cleveland Clinic and who was not involved in this study. “The side effects are minimal, if not zero for the majority of patients. TDM1 is a good adjuvant medicine, but we always strive to do better. ENHERTU offers this best option. “

“The result of this trial is very clinically meaningful for patients with HER-2 positive breast cancer,” Dr. Sara Tolaney, head of the breast oncology division, Dana-Farber Cancer, told ABC News. Institute, which was part of the research team. . She predicted that “this powerful antibody … will radically change the treatment of HER-2 positive breast cancer.”

Breast cancer is the world’s deadliest cancer for women, and about 1 in 5 people with breast cancer test positive for the HER-2 gene. The presence of the HER-2 protein makes breast cancer more aggressive than other types. About 1 in 3 women diagnosed with early breast cancer will see the cancer spread to other organs, and about 72% of these patients will die within five years.

ENHERTU was approved by the Food and Drug Administration in 2019 for inoperable or metastatic (spreading to other organs) HER-2-positive breast cancer. Its use was approved if the patient did not respond to standard treatment and at least two combined options were tried.

“To use ENHERTU as a prior line of treatment, the FDA required a direct controlled trial,” Dr. Sunil Verma, vice president and global clinical head of breast cancer research at AstraZeneca, told ABC News. The group therefore launched a trial in 2017, the results of which were announced publicly on Saturday.

This culminated in the Phase 3 trial, which included around 500 patients over the age of 18 in 15 countries in Asia, Europe, North America, Oceania and South America. Half were treated with ENHERTU, half with TDM1. This trial led by AstraZeneca and Daiichi Sankyo is the first global, randomized, face-to-face clinical trial for HER-2-positive breast cancer.

The trial compared the progression-free survival, or PFS, of ENHERTU to that of TDM1. PFS indicates disease control (tumor size) and looks at how long a patient lives without cancer growing or spreading. After 12 months, less than 25% of patients treated with ENHERTU experienced disease progression or death, while 65% of patients treated with TDM1 experienced disease progression or death.

The safety profile of ENHERTU was consistent with that of previous trials and no new safety issues were identified.

Verma said about 80% of patients on ENHERTU saw their tumor shrink and 16% of patients’ tumors could no longer be seen using imaging technology.

“With the remarkable results of this study, ENHERTU could become the new gold standard treatment for patients with HER-2 positive metastatic breast cancer after standard chemotherapy,” added Verma.

This promising new treatment is called second-line treatment because it is intended to be used only for progression from standard first-line treatment with chemotherapy and Herceptin. But the results suggest that it could perhaps be used earlier in place of chemotherapy.

AstraZeneca and Daiichi Sankyo are already researching whether patients with other cancers – including stomach and lung cancer – could see equally promising results with ENHERTU, Verma said, adding: on other cancers HER- 2-positive. “

Editor’s Note: This article has been updated to make it clear that the reported data results are for ENHERTU alone and not as a combination.

Dr. Madhu Vennikandam, MD, board certified internal medicine physician and gastroenterology researcher at Michigan State University with Sparrow Hospital, East Lansing, contributes to ABC News’ medical unit.


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