Research and clinical trials
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The National Cancer Institute has opened a promising clinical trial aimed at increasing the effectiveness of immunotherapy for patients with unresectable malignant mesothelioma.
This latest study involves combining LMB-100, a man-made protein designed to kill cancer cells, with ipilimumab, an immunotherapy drug recently approved for use by the U.S. Food and Drug Administration. Ipilimumab is also known by the brand name Yervoy.
Although immunotherapy has been successful with some types of cancer, its effectiveness in treating mesothelioma has been selective and lacks sustainability.
This new study was particularly effective in previous lab tests, leading to a phase I clinical trial for both pleural and peritoneal mesothelioma.
“We know it works in mice,” lead researcher Dr. Ravit Hassan told Asbestos.com’s Mesothelioma Center. “Whether it works in humans, only time will tell. We have to see. The goal is to make these tumors more responsive to immunotherapy.”
Hassan is chief of the Malignant Chest and Gastroenterology Branch at the National Institutes of Health Medical Center in Bethesda, Maryland, where the trial began. He has been instrumental in recent advances in the treatment of mesothelioma.
The combination can provide a viable second line option
The trial was designed for patients with inoperable disease in whom both standard chemotherapy and immunotherapy were used earlier before tumor growth returned. It is used for confirmed cases of epithelial or biphasic mesothelioma, the most common type of mesothelioma.
“For patients today, there are really no options or very limited options after chemotherapy and immunotherapy have failed,” Hassan said. “This study presents a reasonable opportunity for benefit. It would be good to see if these patients respond again to immunotherapy.”
The U.S. Food and Drug Administration approved Opdivo and Yervoy, a combination immunotherapy, for first-line treatment of pleural mesothelioma in 2020. This was the first new systemic approval in more than 16 years. However, it only increased the median overall survival time from 14.1 months to 18.1 months, compared to standard chemotherapy.
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The LMB-100 trial follows a previous study
This latest mesothelioma trial builds on an earlier National Cancer Institute study involving pembrolizumab (Keytruda), another immunotherapy drug with a different method of delivering LMB-100.
Previous experience used systemic delivery. This latest trial involves an intratumoral injection of the drug, a new method that will be closely monitored for its ability to better stimulate the immune system’s response.
LMB-100 works by targeting mesothelin, a tumor-associated antigen that is highly expressed on the surface of many different types of tumors, including pancreatic, ovarian, lung, and mesothelioma.
“In mice, you can completely get rid of tumors with this birth. Not just who is injected, but not injected,” Hassan said. “It is one of the reasons for this clinical trial to see if we can achieve the same in patients.”
Researchers Test Safe Dose Levels
Patients in the trial will receive LMB-100 injections into their tumors on Days 1 and 4 for up to two 21-day cycles. It will be combined with up to four doses of ipilimumab on a regular basis.
Through the trial, the researchers expect to determine the safest and best dose levels for both LMB-100 and ipilimumab.
Ipilimumab is known as a checkpoint inhibitor immunotherapy, which helps the body’s immune system attack cancer cells.
LMB-100 was originally designed to extend the effectiveness of immunotherapy. Dr. Ira Bastan, a scientist at the National Cancer Institute, led the drug’s development.
“There is hope on the horizon — more options today for mesothelioma patients than there were a few years ago,” Hassan said. “We just have to see where this goes. Progress is being made.”
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