Mesothelioma Clinical Trial Targets Latest Gene Therapy
September 4, 2019
Pioneering pulmonologists Dr. Steven Albelda and Dr. Daniel Sterman have worked for more than 20 years on developing gene therapy to effectively combat pleural mesothelioma cancer.
The payoff may have finally arrived.
Albelda and Sterman’s long-awaited, phase III clinical trial will open this month to evaluate the efficacy of TR002, a novel gene therapy drug, when used in combination with celecoxib and gemcitabine.
TR002, a form of immunotherapy, is a genetically engineered adenovirus that triggers the anti-tumor effects of interferon, a naturally occurring protein that destroys cancer cells.
“The hope is, if it works like earlier studies have shown so far, that we may have a new treatment option, a new standard-of-care treatment to offer patients with mesothelioma,” said Sterman, director of pulmonary oncology at New York University Langone Medical Center. “We’re excited about the potential.”
Earlier Study Was Impressive
In an earlier, phase II study of TR002, the disease control rate was 87.5% for patients who either were newly diagnosed or were failed by standard chemotherapy.
In second-line treatment, they had a median survival time of 17 months, almost double the historical control. The three-year survival rate was 20 percent.
“A phase III trial gives us the possibility — we have no idea what the results will be — of having another important drug in our armamentarium with potentially proven benefits for mesothelioma patients,” said Sterman, lead investigator of the trial. “The goal here is to get definitive answers, not a suggestion, as to whether the new treatment is better than standard-of-care.”
Albelda and Sterman spoke recently at the Mesothelioma Applied Research Foundation’s Meet the Experts Night, designed to raise awareness for the upcoming clinical trial.
The first patient in the multicenter, international clinical trial is expected to start treatment September 17 in Glasgow, Scotland.
The trial is open to patients with the epithelioid subtype of pleural mesothelioma whose standard treatment has failed. It is randomized, with half the patients receiving the three-drug combination and the other half receiving only the celecoxib and gemcitabine.
Trial Sites Spread Across the U.S.
Host sites within the United States include:
The Churchill Hospital in Oxford, United Kingdom, and the Beatson, West of Scotland Cancer Centre in Glasgow, also are participating.
Sterman expects more international sites to join the trial, including ones in Australia, Russia and Asia. The trial hopes to enroll at least 300 patients worldwide.
Phase III Trial Represents Decades of Research
The gene-therapy drug will be administered only once by catheter and delivered directly into the pleural cavity to the patients selected through the randomization process.
Celecoxib, a drug often used by patients with arthritis, will be given orally twice daily to all patients. Gemcitabine, a common chemotherapy drug, will be given to all patients on the first and eighth day, and then repeated every three weeks until a disease progression is seen.
“We’re hoping the triple-drug combination will demonstrate a significant improvement in survival well beyond standard-of-care treatment,” Sterman said.
The trial represents the peak of more than two decades of research, much of it at the University of Pennsylvania School of Medicine, where Albelda and Sterman worked together for almost two decades.
Sterman joined New York University Medical Center in 2015, but the two continue their collaboration today, looking for an answer to mesothelioma.
The two have been international leaders in the field of gene therapy for many years.
Depending upon the results of the phase III trial, it could be the final step before FDA approval.
The trial is sponsored by Trizell, a gene therapy company with facilities in both the United Kingdom and Finland.
“For the field of mesothelioma, we need to be able to develop these proven treatments to provide a better quality of life, a better quantity of life for patients, and someday find a cure for this disease,” Sterman said.