Biotechnology

For advanced HER2-amplified bile duct cancer, antibody treatment trial

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Bile duct cancer is a rare and aggressive type of gastrointestinal cancer. They include cholangiocarcinomas, which can form in or outside the liver, and cancer of the gallbladder, and are very likely to cause serious illness or be fatal.

Bile duct cancer is a rare and aggressive type of gastrointestinal cancer. They include cholangiocarcinomas, which can form in or outside the liver, and cancer of the gallbladder, and are very likely to cause serious illness or be fatal.

Bile duct cancer affects the bile ducts, which are made up of organs and ducts that make and store bile and release it into the small intestine. They are known as “silent” cancers, because there are usually no symptoms until they reach an advanced stage. Surgery can be effective if bile duct cancer is caught early, but for most patients there is little good treatment.

Now, new research was published June 2 in That Lancet oncology and presented at the annual meeting of the American Society of Clinical Oncology, found antibody treatment helped shrink tumors in some patients with bile duct cancer — specifically a group of people whose tumors produce high amounts of the protein HER2, which can cause cells to proliferate as well. quickly.

The phase 2b clinical trial, known as HERIZON-BTC-01, is a global multicenter effort to evaluate the effectiveness and safety of zanidatamab, an antibody that acts against the HER2 protein, in patients with HER2-amplified bile duct cancer who have not responded to other treatments. Gastrointestinal oncologist James Harding, MD, of the Memorial Sloan Kettering Cancer Center (MSK), and Fan Jia, Director of the Liver Cancer Institute at Fudan University in China, served on the trial steering committee and were first co-authors of the That Lancet oncology Study.

“The incidence of bile duct cancer has increased in recent decades,” said Dr. Harding. “There are currently no approved therapies that target HER2 in this cancer, and therefore there is a significant unmet medical need. The trial results were encouraging — zanidatamab shrunk tumors in a group of patients with HER2-positive disease and was overall well tolerated. This study illustrates the importance of the molecular profiling of these cancers to enable us to match patients with precision drugs that target the hallmarks of their respective cancers.”

Results of Clinical Trials Using Zanidatamab Against HER2-Enhanced Bile Duct Cancer

The study enrolled 87 participants with HER2-amplified bile duct cancer who were either locally advanced or had spread throughout the body and chemotherapy had stopped working. The patients received zanidatamab intravenously (by IV) every two weeks. The antibodies bind to the HER2 receptor and cause a decrease in HER2 on the surface of the cancer cells, helping to slow their uncontrolled growth.

The treatment was effective in shrinking tumors in 41% of patients, the trial found. Half of the patients had a response within 1.8 months, and this response lasted 12.9 months or more in half of the patients who responded to the drug. Physicians are continuing to follow these patients to assess the impact of treatment over a longer period of time, the study authors note.

The most common side effects of treatment were diarrhea (37% of participants) and infusion-related reactions, such as allergic reactions, injection site pain, nausea, or flu-like symptoms (33% of participants). A small number of people experience decreased heart function. No severe side effects were reported.

Zanidatamab is still under investigation and will undergo additional studies to test the safety and effectiveness of the antibody in a larger group of people, the researchers noted. Antibodies are also being evaluated in combination with first-line chemotherapy, as well as for patients with other types of HER2-expressing tumors.

Data from the trial support the potential of zanidatamab as a new targeted therapy when patients do not respond to chemotherapy, the study authors wrote.

“Further research into the evaluation of HER2-targeted therapy in HER2-positive bile duct cancer is critical to improving care for these patients,” said Dr. Harding. “MSK has led the development of many of these therapies over the last few decades in solid tumors, and there are several studies ongoing in New York City and across MSK regional sites. In addition, we have a strong program with surgeons highly experienced in surgery for early stages of disease, and experts in radiation therapy, chemotherapy, and minimally invasive symptom relief for more advanced disease, as well as access to the latest clinical trials.”

This trial was funded by Zymeworks, Jazz Pharmaceuticals, and BeiGene. Additional support was provided by the National Institutes of Health (P30 CA00874), University College London (UCL) Hospital/UCL Biomedical Research Centre, and work was carried out at the National Institute for Health and Care Research’s clinical trial facility.

MSK Disclosure: Dr. Harding reports support from Zymeworks (a non-compensated steering committee), and research support for this work; grants or contracts from Bristol Myers Squibb, Boehringer Ingelheim, CytomX, Debiopharm, Eli Lilly, Genoscience, Incyte, (email protected), Novartis, Polaris, Pfizer, Zymeworks, and Yiviva outside of this work; consulting fees from Adaptimmune, AstraZeneca, Bristol Myers Squibb, Exelixis, Elevar, Eisai, Genoscience (no compensation), Hepion, Imvax, Merck (data and safety monitoring council, or DSMB), Medivir, QED, Tyra, and Zymeworks (no compensation ) outside of this work; and participation on DSMBs or advisory boards for Adaptimmune, AstraZeneca, Bristol Myers Squibb, Exelixis, Elevar, Eisai, Genoscience (without compensation), Hepion, Imvax, Merck (DSMB), Medivir, QED, Tyra, and Zymeworks (without compensation) at outside of this work.


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