New Treatment Boosts Survival in Biliary Cancer
Treatment with ivonescimab plus chemotherapy improved overall survival compared with Imfinzi (durvalumab) plus chemotherapy for patients with previously untreated advanced biliary tract cancer in the phase 3 HARMONi-GI1 trial.
The trial met its main goal of improving overall survival, meaning patients who received the ivonescimab combination lived longer than those who received the Imfinzi combination.
Ivonescimab plus chemotherapy also improved the amount of time patients lived without their cancer worsening and increased the percentage of patients whose tumors shrank or disappeared in response to treatment.
Imfinzi plus gemcitabine and cisplatin has been used as a first-line treatment for advanced biliary tract cancer since the Food and Drug Administration (FDA) approved the combination in 2022 based on findings from the phase 3 TOPAZ-1 trial.
The HARMONi-GI1 trial tested whether a new immunotherapy approach could improve outcomes beyond those achieved with an established immunotherapy and chemotherapy combination.
Patients who received ivonescimab plus chemotherapy lived longer than those who received the Imfinzi combination, according to the topline findings.
The phase 3 HARMONi-GI1 trial included patients with locally advanced or metastatic biliary tract cancer who had not previously received systemic treatment for advanced disease.
Patients received either ivonescimab plus the chemotherapies gemcitabine and cisplatin or Imfinzi plus the same chemotherapy.
They primarily evaluated how long patients lived, as well as how long patients lived without their cancer worsening, how many patients responded to treatment, and what side effects occurred.
In the middle of this development, it’s clear that the potential benefits of ivonescimab could have a significant impact on patients with advanced biliary tract cancer, offering them another treatment option that may improve their chances of survival.
This is particularly important for patients who have limited treatment options, as advanced biliary tract cancer is a devastating disease with a poor prognosis.
Ivonescimab is an investigational bispecific antibody designed to target two pathways involved in cancer, PD-1 and VEGF.
PD-1 is part of a pathway that cancer cells can use to avoid being attacked by the immune system, while VEGF helps tumors develop blood vessels that can support their growth.
By targeting both pathways at the same time, ivonescimab is designed to help the immune system recognize and attack cancer while interfering with the development of blood vessels that can support tumor growth.
The approach differs from Imfinzi, which targets PD-L1, and ivonescimab targets two different processes that can help cancer grow.
Patients and their care teams will have to wait for the complete results of the HARMONi-GI1 trial to determine the full extent of the benefits and risks of ivonescimab in advanced biliary tract cancer.
Detailed findings from HARMONi-GI1 are expected to be presented at a future medical meeting and published in a peer-reviewed journal.
Researchers will also be looking at ivonescimab‘s potential use in other types of cancer, including breast cancer, where it has already shown promise in early trials, and lymphoma treatment.
