An upcoming Phase 2 clinical trial is set to evaluate Novocure‘s Tumor Treating Fields, known as TTFields, in combination with Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer (NSCLC).
TTFields is a treatment method that uses electric fields tuned to specific frequencies to interrupt cancer cell division, causing cancer cells to die and limiting tumor growth. The therapy has minimal effects on non-cancerous cells.
In the U.S., TTFields is approved to treat mesothelioma and certain kinds of brain cancer. Studies in other cancer types, such as ovarian cancer, also have been promising.
Keytruda, marketed by Merck Sharp & Dohme — MSD, a subsidiary of Merck — is an immune checkpoint inhibitor. It works by blocking PD-1 signaling, a process that is used by many tumor cells to escape immune destruction. By blocking PD-1 signaling, Keytruda can promote an anti-tumor immune response, which kills cancer cells and curbs tumor growth.
“Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control,” William Doyle, executive chairman of Novocure, said in a press release.
Novocure and MSD will together conduct a Phase 2 pilot study testing a combination of these two therapies as a first-line treatment for advanced or metastatic NSCLC that is positive for PD-L1 (a molecule expressed by tumor cells). NSCLC is the most common type of lung cancer, accounting for 80-85% of cases.
“We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with Keytruda in first-line NSCLC,” Doyle said.
The upcoming study, which is expected to begin later this year, is designed to enroll approximately 66 people in the U.S.
The study’s primary endpoint — its main measurement of efficacy — is the objective response rate (ORR), which refers to a response that is clearly measurable without bias; in cancer research, it typically means that the tumor has decreased in size.
Other endpoints used in the study will include overall survival, progression-free survival, duration of response, and disease control rate after 18 weeks of treatment. The trial also will evaluate the safety of the combination treatment.
“We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields,” Doyle concluded.
