Pleural and peritoneal mesothelioma patients are eligible for a new clinical trial that combines the latest antibody-drug conjugate with standard-of-care chemotherapy at the Ochsner Medical Center in New Orleans.
The drug, anetumab ravtansine (BAY 94-9343), is the highly touted conjugate that mixes immunotherapy with cytotoxic therapy and targets mesothelin, the tumor surface protein found in 85-90 percent of mesothelioma cancer patients.
The Ochsner trial, which is currently recruiting participants, is the first time researchers will administer anetumab ravtansine in a first-line setting for mesothelioma.
“It’s exciting, especially when you realize these patients don’t have much in the way of other options,” Ochsner oncologist Dr. Robert Ramirez told Asbestos.com. “What we’re trying to do is make standard of care better.”
The University of Chicago Comprehensive Cancer Center, the Hollings Cancer Center at the University of South Carolina in Charleston, the Henry Ford Cancer Institute in Detroit and the National Cancer Institute in Bethesda, Maryland, also are involved in the trial, which is expected to last a year.
“The best-case scenario is that it keeps this cancer from growing for a long time,” Ramirez said. “But in reality, with any patient you can’t cure, the goal is to improve or at least maintain the quality of life for as long as possible, and hopefully, that translates into living longer. If this drug helps us get there, it’s a good thing, and one more option.”
Anetumab ravtansine shrank mesothelioma tumors in 50 percent of patients in an earlier, multicenter phase I study. Results of that trial were presented at the 2016 American Society for Clinical Oncology (ASCO) annual meeting.
Renowned thoracic surgeon Dr. David Sugarbaker, who has pioneered mesothelioma treatment advancements for 20 years, told Asbestos.com earlier that he is exploring the idea of combining the drug with aggressive cytoreductive surgery.
“It might be the home run we’re looking for,” Sugarbaker said.
Baylor College of Medicine, where Sugarbaker is director of the Lung Institute, and Ochsner were part of a recent phase II study that used anetumab ravtansine in a second-line setting for tumors that progressed after standard chemotherapy.
Results from the phase II trial were positive, raising the hopes of cancer researchers across the country.
This latest trial will explore the synergistic effect of using anetumab ravtansine in combination with cisplatin and pemetrexed — the most common chemotherapy drugs used for treating mesothelioma.
Researchers will deliver chemotherapy intravenously once every three weeks. The trial drug will be given to participants on the first, eighth and fifteenth day.
Eligible patients must have unresectable disease, either pleural, which involves the thoracic cavity, or peritoneal, which starts in the abdominal cavity.
The trial also is open to patients with non-small cell lung cancer.
Mesothelioma is a rare and aggressive cancer caused primarily by exposure to asbestos. Pleural mesothelioma is the most common type, while peritoneal accounts for an estimated 20 percent of all cases.
Anetumab ravtansine also is being studied with other malignancies, including pancreatic, ovarian and breast cancers.
Joining a clinical trial gives patients access to experimental drugs not yet approved by the U.S. Food and Drug Administration. Standard-of-care treatment for mesothelioma has not changed for more than a decade.
“The advantage of being in a trial is having a whole team looking after you, and not just your doctor,” Ramirez said. “It’s our whole research team looking after a patient.”
Patients coming to Ochsner and needing overnight accommodations will have the option of staying at the nearby American Cancer Society’s Patrick F. Taylor Hope Lodge or the Brent House Hotel, which is connected to the hospital. It can be set up by the clinic staff.
For a person diagnosed with a cancer such as mesothelioma, which has no definitive cure, a clinical trial offers the chance of extending life expectancy and survival, but it also helps future patients with new therapies.
“This is a trial that not only could benefit the patient,” Ramirez said. “But it could advance the field.”