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Ramucirumab Shows Promise in Mesothelioma Clinical Trial

Research & Clinical Trials

Written by Tim Povtak

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Publication Date: 06/09/2020

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Patients with pleural mesothelioma cancer experienced a significant survival advantage when ramucirumab, a novel immunotherapy drug, was added to chemotherapy in a treatment regimen.

Ramucirumab, marketed by Eli Lilly and Company as Cyramza, is a monoclonal antibody that works by targeting and restricting a protein that stimulates blood vessel growth within tumors.

An ongoing phase II clinical trial in Italy recently reported almost double overall survival rates when ramucirumab was added to gemcitabine in second-line mesothelioma treatment.

“These positive data may be the beginning to change the clinical practice in the choice of second-line therapy for pleural mesothelioma,” said oncologist Dr. Maria Pagano, General Hospital Arcispedale Santa Maria Nuova in Reggio Emilia, Italy.

Ramucirumab Has FDA Approval for Other Cancers

The U.S. Food and Drug Administration already has approved the use of ramucirumab for certain types of liver, stomach and colorectal cancers. Its use with mesothelioma is still in the clinical trial stage.

In the randomized trial of patients whose disease had progressed after first-line treatment of standard chemotherapy, 81 patients were given ramucirumab and gemcitabine in combination, and 80 received only gemcitabine.

Overall survival rates from the start of the trial were 13.8 months for those getting the combination, and only 7.5 months for those receiving just the chemotherapy.

The overall survival rates were 74.7% at six months and 56.5% at one year with the combination, but only 63.9% and 33.9% with the single agent.

This combination also showed a 6.2 month to 3.3 month median progression-free survival advantage over chemotherapy alone. Adverse side effects from ramucirumab were minimal, with five patients experiencing grade 3 or 4 hypertension.

Most patients in the trial (73.9%) were male, and 81.9% had the epithelioid subtype of mesothelioma. Treatment involved gemcitabine on days one and eight of a 21-day cycle. Ramucirumab was given only on day one of the cycle. Treatment continued until disease progression.

“The lack of therapeutic resources has led us to [intensify] the search for new therapeutic combinations,” Pagano said. “Ramucirumab plus gemcitabine can represent a new option in the second-line treatment of patients with pleura mesothelioma.”

ASCO Presentations on Mesothelioma

Pagano presented her findings at the recent American Society of Clinical Oncology virtual scientific program.

Other presentations at the ASCO program regarding potential treatment advances for mesothelioma included:

A phase II clinical trial at MD Anderson Cancer Center in Houston studied 20 patients with relapsed and unresectable peritoneal mesothelioma who received the immunotherapy combination of atezolizumab and bevacizumab. The one-year overall survival rate was 79%, and the one-year progression-free survival rate was 54%.
A multicenter phase II study based at the Sidney Kimmel Cancer Center in Baltimore found improved survival times when adding the immunotherapy drug durvalumab to first-line chemotherapy. Median overall survival of the 55 patients at multiple centers was 20.4 months, leading to an upcoming phase III study.
A phase I clinical trial at the UPMC Hillman Cancer Center in Pittsburgh that studied the use of MGD013, an investigational bispecific molecule, found effectiveness as a single agent and in combination for multiple tumor types, including pleural mesothelioma. The drug, which generates better T-cell activation, had an overall response rate of 42.9%.

Ramucirumab also is being touted as part of an ongoing mesothelioma clinical trial in combination with nivolumab (Opdivo), another immunotherapy drug.

That combination trial, which is still accepting new patients, is being conducted at the Regions Hospital Cancer Center in St. Paul, Minnesota; the Karmanos Cancer Institute in Detroit; the Greenebaum Cancer Center in Baltimore and the Moffitt Cancer Center in Tampa, Florida.