The results of a new study published today (Saturday) at the European Oncology Conference (ESMO) may lead to a revolution in the treatment of metastatic breast cancer.
The results show very high efficacy and stoppage of disease progression among the patients.
According to the study, the progression of the disease was reduced by 72% in patients with metastatic HER2 metastatic cancer who were treated with a drug called anharto, compared to patients who received the currently accepted drug for metastatic disease called cadisilla.
The study also found that the disease did not progress for a period 3.5 times longer in those who received the new treatment (Anharto) compared to the existing one.
The survival time without progression of the disease was 25.1 months compared to only 7.2 months among the patients who received Qadsilla.
The response to treatment was better: about 80% of all patients in the group that received Anharto responded to treatment (the disease receded by more than 30%), compared with only 34% among the group that received cadisla.
The study (Phase 3) involved 524 HER2 metastatic breast cancer patients from around the world.
All patients were in advanced stages of the disease after at least one series of treatments (treatment line) and the mean age was 54. The patients were randomly divided into two groups: one group (which included 263 patients) received the currently accepted treatment "cadsale" and a second group (which included 261 patients) Received a new drug - "Anharto".
One in four women with breast cancer will be diagnosed with HER2 cancer where the tumor expresses this type of protein.
About 1250 women are diagnosed with this type of cancer in Israel every year.
It is an aggressive cancer that affects the patient's quality of life and the chances of prolonging her life.
At present, the existing treatment for patients with metastatic stage of the disease is chemotherapy with herceptin in the first stage and after the disease has progressed - treatment with Kedselia.
The results of the study demonstrated the greatest delay in disease progression in patients - even more so than Herceptin treatment, which is considered a historic breakthrough.
The study was presented at the main session of the conference reserved for the most prominent studies this year.
The researchers note that it is expected to change research in the field and may lead to a dramatic change in the worldwide treatment of HER2 metastatic breast cancer patients.
Astraznica's 'Anharto' treatment was approved last year with rapid approval by the U.S. Food and Drug Administration in light of unprecedented results in a Phase 2 study on patients who have exhausted all treatment options. The drug is a "target-guided missile" - an antibody to which chemotherapy is attached, which is broken down in the body only in the vicinity of the tumor. The treatment was submitted this year for approval by the drug basket committee, which is expected to begin work in the coming weeks.
"The data presented are exciting. This is a significant breakthrough that cannot be underestimated," said Dr. Noa Efrat Ben Baruch, chair of the Breast Group at the Israeli Oncology Association. The structure of the drug is similar to the existing treatment, it is an antibody to which the chemotherapy molecule is bound, but there are differences in the type of chemotherapy and the design of the drug.
"The women who participated in the study were patients with brain or liver metastases who received at least one treatment line for metastatic breast cancer and 50% of them received more than one treatment line," explained Dr. Efrat Ben Baruch. Did not progress more than a year, compared with 34% of patients receiving the existing treatment. This is a drug that gives a much better answer than the existing options. These are impressive results on any scale. We added a treatment option that gives patients a significant lifespan. "The chairman of the breast group at the Israeli Oncology Association emphasized that no cases of significant side effects were found, and in particular no significant cases of lung disease were observed in previous studies.