Research & Clinical Trials

New Mesothelioma Immunogene Clinical Trial Set to Launch

Written By:
Mar 22, 2016
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Written By: Tim Povtak,
March 22, 2016

For more than a decade, pulmonologist Dr. Dan Sterman has believed immunotherapy would become the catalyst for major advancements in the treatment of malignant pleural mesothelioma.

Today, he is closer than ever to proving that point.

Sterman, director of pulmonary medicine at New York University, soon will help launch a multicenter clinical trial involving a powerful immunogene therapy combination that may change the way this deadly asbestos-related cancer is viewed.

“I believe that immunotherapy will become the fourth pillar of treatment for mesothelioma (joining chemotherapy, radiation and surgery),” Sterman told “It won’t be one immunotherapy drug, but a cocktail of drugs that together will help turn mesothelioma into a chronic disease that people can live with for a long time.”

Pleural mesothelioma typically comes with a prognosis of a six- to 15-month life expectancy, even with a multidisciplinary approach. Immunotherapy involves sparking a patient’s own immune system to fight the cancer.

Sterman is not predicting a cure, but an ability to provide long-term control where patients can extend their lives and maintain a good quality of life for many years.

A recent, smaller study of 40 patients with unresectable pleural mesothelioma at the University of Pennsylvania Abramson Cancer Center initiated the upcoming trial. Some of the researchers from that study, including Sterman, have moved to other institutions, including NYU, the University of Maryland and the Cleveland Clinic.

Most Mesothelioma Patients Benefit from Second-Line Treatment

Patients in an earlier study received two intrapleural doses of the human interferon-alpha 2b gene, the anti-inflammatory drug celecoxib and chemotherapy with gemcitabine or pemetrexed.

The most promising response came from those receiving second-line treatment. Those with first-line therapy saw only a slight improvement over historical controls.

Patients had a median overall survival of 15 months — almost double the normal survival. That suggested a subset of patients who would respond well to advanced therapy.

The median overall survival for patients receiving second-line treatment was 21.5 months with 32 percent of patients living after 25 months.

“This is obviously promising,” Sterman said. “And it sends enough of a signal to move forward with a larger, randomized trial that could definitively show if we can do what we set out to do, and that’s to prolong a patient’s life and maintain a high quality of life.”

The upcoming trial will involve an immunogene therapy similar to the smaller study, along with chemotherapy agent gemcitabine, which has shown it can modify the immune system and the tumor, making it more susceptible to treatment.

10 or More Cancer Centers Will Host Mesothelioma Clinical Trial

The clinical trial is expected to start later this year at 10 or more mesothelioma specialty centers across the country.

“There is a synergistic benefit between the two agents and not just an additive,” Sterman said. “That’s important. This can magnify the effectiveness.”

Patient commitment to the upcoming clinical trial will include only two doses of the drugs given at four-day intervals. The genetic delivery of the immunotherapy drug also tested successfully in bladder cancer, and there are preliminary studies planned for lung cancer. Theoretically, it could benefit those with ovarian and colon cancers.

“Ultimately, this has broad implications not only with mesothelioma, but also with other cancers,” Sterman said.

The pleural space will serve as the platform for the drug delivery with mesothelioma, which will make this trial unique.

There currently is no FDA approved second-line treatment for mesothelioma — a glaring void many believe will be filled soon with immunotherapy agents.

Although the trial is aimed at patients with unresectable disease, Sterman expects similar studies with neoadjuvant delivery for patients having aggressive surgery. Other immunotherapies may be used during the post-surgery period.

“It’s the logical next step,” he said. “There is a lot of interest now about how best to use these drugs potentially to enhance the benefits of surgery.”

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