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Combination Mesothelioma Therapy Begins Pivotal Trial

ByAlex Strauss

mesothelioma treatment combinationA combination mesothelioma therapy that showed promise in early trials is finally being studied on a larger scale.

The power-packed chemo-immuno-gene therapy known as TR002 has the potential to change the outlook for thousands of malignant mesothelioma patients.

A small trial of the combination mesothelioma therapy in 2016 produced “significantly higher” mesothelioma survival rates than most patients are told to expect.

Drug company Trizell announced last month that the combination will now be tested on 300 patients at sites in the US, Europe, Australia and Russia.

Combination Mesothelioma Therapy Starts with Gene Therapy

TR002 is an investigational gene therapy for mesothelioma patients who have failed first-line chemotherapy.

This combination mesothelioma therapy is based on the human interferon-alpha 2b gene. The gene is delivered to mesothelioma patients via a virus that is altered to serve as a carrier or “vector”.

Once the drug-carrying virus is delivered into the pleural cavity (around the lungs), the virus breaks down and the gene can do its work.

Interferon alpha-2b is a protein the body uses to fight cancer. This first step of the combination mesothelioma therapy turns cells into interferon alpha-2b producing machines. This enhances the body’s ability to fight mesothelioma.

Chemotherapy is Second Part of Treatment

After mesothelioma patients receive the TR002 portion of the combination mesothelioma therapy, they have a two-week “break”. Patients will then have chemotherapy with gemcitabine.

A previous Phase 2 study of this combination mesothelioma therapy took place at the Abramson Cancer Center. That trial included 40 mesothelioma patients with unresectable pleural mesothelioma. Some had never had any chemotherapy and some were having chemotherapy for the second time.  

The overall disease control rate with the combination mesothelioma therapy was 87.5 percent. Patients who were having chemotherapy for the second time survived nearly twice as long as is normally expected (17 vs. 9 months).

“The results that we noted in our previous study showed significant prolongation of life expectancy and particularly so for about 25 percent of these refractory patients who have gone on to live two and in some cases three years and more,” says Daniel H. Sterman, MD.

Dr. Sterman is Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health. He and Dr. Steven Albelda of Pennsylvania’s Perelman School of Medicine pioneered the new treatment.

The new trial of the combination mesothelioma therapy will enroll 300 mesothelioma patients who have failed first-line chemotherapy.

Sources:

“Trizell Ltd. announces Phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma”, March 20, 2019, Biospace, News Release, https://www.biospace.com/article/releases/trizell-ltd-announces-phase-3-pivotal-study-of-interferon-alfa-2b-gene-therapy-in-malignant-pleural-mesothelioma/

Sterman, DH, et al, “Pilot and feasibility trial of immuno-gene therapy of malignant mesothelioma using intrapleural delivery of adenovirus-interferon-alpha combined with chemotherapy”, March 11, 2016, Clinical Cancer Research, Epub ahead of print

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