A new study out of the National Cancer Institute is combining an immune checkpoint inhibitor with a monoclonal antibody. The belief is the combination of ipilimumab (Yervoy) and LMB‑100 can ignite an immune response while slowing down tumor spread.
It’s a phase 1 trial looking for up to 20 patients with diagnosed mesothelioma. The primary goal is determining the safest dose amount and frequency of each drug. Other measurements are progression‑free survival, overall survival and disease response to treatment.
What Are LMB‑100 and Ipilimumab?
Ipilimumab is an immune checkpoint inhibitor. It’s FDA‑approved for malignant pleural mesothelioma when used with another immunotherapy drug, nivolumab (Opdivo).
Ipilimumab blocks a connection between CTLA‑4 and B7, two protein receptors that link T‑cells and mesothelioma cells together. Blocking the link helps the immune system properly fight mesothelioma.
LMB‑100 is a monoclonal antibody that targets mesothelin, which is a protein found on cancer cells. Monoclonal antibodies like LMB‑100 are lab‑generated drugs teaming with the immune system. LMB‑100 attaches to mesothelin and then attacks cancer cells.
How the LMB‑100 And Ipilimumab Study Will Work
As a phase 1 study, participants will only undergo four 21‑day cycles of treatment. The remainder of the study is for follow‑up scans.
Patients will receive LMB‑100 on Days 1 and 4 for a maximum of two 21‑day cycles. So there will be at most four injections of LMB‑100 into tumors. Patients will stay in the hospital for inpatient care for eight days after the Day 4 injection.
Patients will receive ipilimumab intravenously. This treatment will last up to four cycles, with one dose per cycle (Day 2 on the first two cycles and Day 1 on the next two cycles).
Following the end of treatment, patients will undergo follow‑up scans every six weeks until the cancer worsens.
Combining LMB‑100 with an immune checkpoint inhibitor is not a new idea. A previous study paired the monoclonal antibody with pembrolizumab (Keytruda). The median survival time was one year. Four patients had tumor responses (the disease shrank in size), and the overall survival times for those four were:
- 39 months (and counting at time of study reporting)
- 32.6 months (and counting at time of study reporting)
- 27.7 months
- 13.8 months
If you’re interested in this study or another, please contact our team. Patient advocate and registered nurse Karen Ritter can help you find a clinical trial for mesothelioma. Email her at email@example.com.
Sources & Author
- Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma. Clinicaltrials.gov. Retrieved from: https://clinicaltrials.gov/ct2/show/NCT04840615. Accessed: 06/30/2021.
- Enhanced efficacy of mesothelin-targeted immunotoxin LMB-100 and anti–PD-1 antibody in patients with mesothelioma and mouse tumor models. Science Translational Medicine. Retrieved from: https://stm.sciencemag.org/content/12/550/eaaz7252. Accessed: 06/30/2021.