A cancer medication of the Astrazeneca and Daiichi Sankyo partners currently approved as a second -line or posterior treatment for metastatic breast cancer have provisional clinical data that show that it helped patients live up to the height of those generated by this directed therapy.
Astrazeneca and Daiichi Sankyo are not revealing specific details of Phase 3 test in the Metastatic positive sinus of Her2 still. But the companies said Monday that the planned provisional analysis showed that the medicine, inheru, led to a “highly significant and clinical significant improvement in free survival of progression.” This measure was made compared to a combination of triple drug that is currently used as a first -line treatment for this type of cancer. These results are important because many patients with metastatic breast cancer do not live enough to collect a second line of treatment.
Inhertu is a conjugate of antibody drugs (ADC) that was discovered by Daiichi Sankyo and develops and markets Bee under an association with Astrazeca. The drug antibody component is directed to her2, an overexpressed protein in breast cancer cells. Modtu was first approved by the FDA in 2019 as a third -line treatment for positive metastatic breast cancer for her2. The therapy expanded its approved use to the second line treatment of this type of cancer in 2022.
The provisional results announced Monday from a global test of phase 3 that walked to 1,157 patients. Inhertu was tested by himself and in combination with Pertuzumab, a Roche medicine marketed under the Perjeta brand. The drug drug was compared to the chemotherapy taxol combined with perjeta and another drug of Roche monoclonal antibodies, Herceptin. This combination of three drugs is a standard first -line treatment for Metastatic Breast cancer of HER2 positive.
Astrazeneca and Daiichi Sanky said that the improvement in progression -free survival was observed in all the subgruces of prepecified patients who received in the paired with perjeta. In the key secondary objective of measuring general survival, the data is not yet mature. But companies said that general general survival data show a trend that favors the combination of ENHERU compared to the standard regime of three drugs. A second cohort that is evaluating Modtu as a monotherapy compared to standard treatment remains linked and will continue to the final analysis that measures the free survival of progression.
“This is the first essay in more than a decade to demonstrate superior efficacy in a wide population of patients with Metastatic Breast Cancer HER2 positive compared to the current first -line care standard,” said Susan Galbraith, executive vice president of R&D of oncology hematology, Astrazeneca, in a prepared statement. “This is a significant milestone for patients and establishes the bases for EN-HERT in combination with Pertuzumab as an important treatment option in the positive first-line Her2 environment.”
On security, companies said that the results so far show the security profile of the inheru and Perjeta combination is consistent with the known profiles of each therapy. The Enhertus label carries a black cash warning for the risk of interstitial pulmonary disease. Companies said more data will be presented at an upcoming medical meeting and will be shared with regulators.
According to the terms of the Association between Astrazeneca and Daichii Sankyo, the two companies share in the development of the overall exception of Enhertu for Japan, where Daiichi Sankyo clings to ADC. Companions reported more than $ 3.7 billion in combined sales for the product in 2024, an increase of more than 46% compared to medicine sales in the previous year.
Public Domain of Stuart S. Martin, through the National Cancer Institute
