Research & Clinical Trials
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Adding the drug ramucirumab to gemcitabine chemotherapy worked especially well in a recent clinical trial involving second-line treatment for patients with pleural mesothelioma.
Ramucirumab, an immunotherapy drug also known by the brand name Cyramza, is a monoclonal antibody that works by targeting and restricting a protein within that stimulates blood vessel growth tumors.
Impressive results in the phase II clinical trial moved the drug combination closer to filling the long-standing void for a second-line mesothelioma treatment.
The Lancet Oncology recently published results of the study, which was conducted in 26 hospitals throughout Italy.
“This combination could be a novel, well-tolerated and active treatment option for patients who have progressed on first-line chemotherapy,” the authors wrote. “The overall survival gain was achieved without a marked increase in toxicity.”
Addition of Immunotherapy Boosts Survival
The randomized, double-blind, placebo-controlled trial involved 161 pretreated patients. Eighty patients received the combination treatment, while 81 received gemcitabine and a placebo.
All participants had experienced disease progression after the inevitable failure of traditional first-line treatment of pemetrexed and cisplatin chemotherapy.
Results, which were measured from the time of second-line treatment randomization, included:
Gemcitabine/Ramucirumab vs. Gemcitabine/Placebo
|Median overall survival||13.8 months||7.5 months|
|6-month overall survival||76%||56.5%|
|12-month overall survival||63.9%||33.9%|
|Median progression-free survival||6.4 months||3.3 months|
|Disease control rate||73%||52%|
|Duration of response||8.4 months||5.4 months|
According to study authors, the clear advantage of adding ramucirumab came regardless of histological subtype and time-to-progression of earlier first-line treatment.
“The results show that the addition of ramucirumab to gemcitabine can provide a notable improvement in overall survival,” the authors wrote. “This combination could be a new option in this setting.”
Ramucirumab Approved for Other Cancers
Ramucirumab, as a single drug or in combination with different chemotherapy agents, has already been approved for second-line treatment of colorectal cancer, non-small cell lung cancer, gastric adenocarcinoma and hepatocellular carcinoma.
With pleural mesothelioma, a rare cancer with no definitive cure, gemcitabine is typically used alone in second-line treatment for patients hoping to extend survival. It has not been very effective for most patients on its own.
In this latest study, adverse treatment side effects from the drug were not a big issue for most participants. Serious adverse events were reported in 6% of those receiving ramucirumab and 5% of those getting the placebo. The most common grade 3 or 4 adverse event was neutropenia, or low white blood cell count, in 20% of those receiving ramucirumab and 12% of those with the placebo.
Additional Studies Show Effectiveness
Marketed by Eli Lilly and Company, ramucirumab is receiving rave reviews for second-line treatment when used in combination with nivolumab (Opdivo), another immunotherapy, in an ongoing, multi-center phase II clinical trial in the United States.
Oncologist Dr. Arek Dudek opened that trial initially at Regions Hospital Cancer Care Center in St. Paul, Minnesota, but he has been joined by the Moffitt Cancer Center in Tampa, Karmanos Cancer Center in Detroit and the Greenebaum Cancer Center in Baltimore. That trial is expected to conclude in 2022.
“I’m hopeful that the results will change the way we treat this cancer,” Dudek said. “When chemotherapy fails a patient with mesothelioma, there isn’t much left to do. This combination brings a completely different level of engaging the immune system.”
The combination of nivolumab and ipilimumab was approved by the Food and Drug Administration in 2020, the first new systemic approval for mesothelioma in 15 years. Some patients are using it now in first-line treatment instead of the standard chemotherapy.
Most oncologists today believe the future of mesothelioma treatment – like many cancers – will involve immunotherapy in some combination.
The use of ramucirumab with chemotherapy could be part of the next second-line treatment advancement for pleural mesothelioma, which is caused by exposure to asbestos.
“There is a substantial unmet need for new therapies in pretreated malignant pleural mesothelioma,” the authors concluded. “This combination warrants exploration in a further prospective phase III trial.”
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