News of a new phase 3 Study may bring hope to pleural mesothelioma patients across the world who have stopped responding to standard chemotherapy. Trizell Ltd. recently announced that is has opened a phase 3 study of their promising new gene therapy for pleural mesothelioma, TR002.
The current first-line and only approved drug therapy option for pleural mesothelioma is the chemotherapy combination of Alimta® (pemetrexed) and cisplatin. The pleural mesothelioma prognosis is poor. Following failure or complications with chemotherapy, there is no approved secondary option and median life expectancy is around 9 months.
Trizell Ltd. is looking to offer a viable secondary treatment option for pleural mesothelioma patients who have stopped responding to standard chemotherapy. Their phase 3 study will test the effectiveness of TR002—a gene therapy that triggers the body’s natural production of anti-tumor proteins.
New Gene Therapy for Pleural Mesothelioma
The new phase 3 study will compare the overall survival rate (OS) of patients undergoing TR002, when paired with chemotherapy, compared to the survival rates of patients who receive chemotherapy alone.
The study is open-labeled, meaning both the researchers and the study participants know which group is receiving TR002 and chemotherapy and which is receiving chemotherapy only. The study is also randomized, meaning patients are divided into two study groups at random.
Around 300 pleural mesothelioma patients who have failed chemotherapy will participate in the trial. For study participants in the treatment group, TR002 will be given by catheter directly into the outer lining of the lungs as a single dose. Celecoxib (a non-steroidal anti-inflammatory) and gemcitabine chemotherapy will begin 14 days later.
Study participants in the control group will receive celecoxib and gemcitabine chemotherapy only. Associated treatments and observations will continue in both groups until researchers notice the treatments aren’t working.
Researchers are hoping to notice stabilized disease or tumor size reduction in patients who receive the gene therapy. This is an international research study and will include sites in the United States, Europe, Australia and Russia.
Results from previous studies on TR002 are promising. This phase 3 clinical trial could potentially result in developing a secondary therapy for pleural mesothelioma patients who have stopped responding to standard treatment.
About TR002 Gene Therapy
TR002 was developed by Drs. Albelda, Sterman and Evan W. Alley at the University of Pennsylvania. The three doctors developed this new gene therapy to activate the body’s anti-tumor response as a way for the body to fight mesothelioma.
TR002, is a virus (adenovirus) containing the gene interferon alfa-2b. The gene therapy is introduced directly into the pleural cavity of the lungs, where it enters the cells of the pleural lining. Upon entering, the virus breaks down, leaving the active alfa-2b gene behind. The genes in the pleural lining pick up the alfa-2b gene and cause it to produce high volumes of the gene.
Alfa-2b proteins are naturally occurring proteins found in the body and are used to fight cancer. TR002 is different from other gene therapies because it transforms the cells within the pleural lining into supercharged micro-factories that produce high volumes of cancer-fighting proteins.
TR002 gene therapy for pleural mesothelioma was investigated in a previous phase 2 study at the Abramson Cancer Center. The study included 40 patients who were either newly diagnosed or failed to respond to the standard chemotherapy treatment for pleural mesothelioma.
Participants in the second-line treatment group (those who failed to respond to chemotherapy) had a doubled median survival time from previous studies. Results from the study showed around 25% of these patients living at least 2 years and 20% at least 3 years.
Access to Clinical Trials and New Therapies
New clinical trials testing immunotherapy and gene therapy for pleural mesothelioma are essential to increasing the overall mesothelioma survival rate and finding a cure.
Patients who have stopped responding or are experiencing side effects from standard chemotherapy can ask their doctor about clinical trials testing new immunotherapies and gene therapies. Studies similar to this new phase 3 trial may also be suitable for pleural mesothelioma patients who have relapsed.
Be sure to contact your mesothelioma specialist if you are interested in participating in clinical trials. You can also speak to one of our Patient Advocates to get connected with a specialist or mesothelioma treatment center.