Phase 2 Study of Potential Treatment for Pleural Mesothelioma Now Recruiting Patients

Phase 2 Study of Potential Treatment for Pleural Mesothelioma Now Recruiting Patients

The Baylor College of Medicine’s Mesothelioma Treatment Center at Baylor St. Luke’s Medical Center has began recruiting patients with malignant pleural mesothelioma in a clinical trial to test an investigational drug called anetumab ravtansine. The study will evaluate the safety and efficacy of anetumab ravtansine versus Navelbine (vinorelbine) in patients whose disease has progressed following initial chemotherapy.

“The disease is particularly challenging because by the time it’s detected – often 20 to 40 years after exposure to the cancer-causing asbestos – the disease can be very advanced,” David Sugarbaker, MD, professor of surgery, chief of the division of thoracic surgery and director of the Mesothelioma Treatment Center and Lung Institute at Baylor, said in a press release. “Currently, available treatment options are limited for patients whose mesothelioma has progressed or does not respond after initial anticancer treatment, so clinical research is highly important in helping advance our understanding of how to treat it.”

Most mesothelioma cells have high levels of the mesothelin protein, a protein that also is found in lung, stomach and breast cancers. Conversely, its expression is restricted in normal tissues, posing it as an attractive target for anticancer therapies.

The new drug, which is an antibody linked to a chemotherapy drug, works by binding to mesothelin in the cancer cells and delivering the chemoterapeutic agent directly into those cells, leaving the mesothelin-negative cells unharmed. It has shown positive results in mesothelioma patients, as well as in ovarian cancer patients, with a high number of participants of a Phase 1 trial reaching partial responses or stable disease.

The ongoing randomized Phase 2 clinical trial (NCT02610140) will now assess anetumab ravtansine as a second-line therapy in patients with metastatic mesothelioma that as continued to grow despite treatment with Alimta (pemetrexed) and platinum-based chemotherapy, which includes Platinol (cisplatin) and Paraplatin (carboplatin).

The study will enroll 210 patients, who will be randomized to anetumab ravtansine every three weeks, or weekly to Navelbine, until their disease progresses or they experience severe side effects. The study’s primary endpoint is progression-free survival, and secondary endpoints include overall survival, objective response rate, and duration of response. The number of patients who develop serious side effects also will be assessed.

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