In a striking departure from earlier this year’s promising findings, Novocure’s groundbreaking technology known as Tumor Treating Fields (TTFields) has encountered a setback in a recent study involving ovarian cancer patients. The company’s announcement on Monday revealed that the INNOVATE-3 clinical trial, which explored the potential of combining TTFields with the chemotherapy drug paclitaxel for patients with platinum-resistant ovarian cancer, failed to achieve its primary objective.
The study sought to establish whether TTFields, which involves administering high-frequency electric fields through the skin to disrupt the division and reproduction of cancer cells, could outperform the use of paclitaxel alone in extending overall survival. Despite the hopeful premise, the trial’s 18-month follow-up demonstrated nearly equivalent survival rates between the two groups—those who received both TTFields and paclitaxel and those treated solely with the chemotherapy drug.
While TTFields received initial clearance from the FDA in 2011 for the treatment of glioblastoma, its potential efficacy in ovarian cancer was less successful in this recent study. The trial encompassed approximately 280 participants in each treatment cohort, all of whom had previously undergone up to five other therapeutic interventions for ovarian cancer without substantial success.
Upon completion of the treatment regimen, the analysis revealed a median overall survival rate of 12.2 months for the TTFields group. This modest increase of three months in comparison to the paclitaxel-only group, which exhibited a median survival of 11.9 months, underscored the technology’s limited impact.
Novocure is presently collaborating with the study’s investigators to prepare a comprehensive release of the study’s findings. Amid the disheartening outcome, there were positive aspects. Novocure reported that TTFields therapy was well tolerated across the patient population. Additionally, a subgroup analysis provided a glimmer of hope, indicating that patients who had undergone only one prior treatment before enrolling in the study might experience an extended survival rate compared to those receiving paclitaxel alone.
William Doyle, Novocure’s executive chairman, pointed to this finding as evidence of the potential benefits of initiating TTFields therapy early in the treatment journey. While acknowledging the overall disappointment of the study results, Doyle emphasized the encouraging nature of the subgroup analysis.
In light of the less-than-favorable outcomes, researchers are continuing to delve into subgroup analyses of the trial data to identify the subset of patients that could potentially derive the greatest advantage from TTFields therapy. As Dr. David O’Malley, a primary investigator in the study, conveyed, variables such as treatment exposure and the number of prior therapies proved to be relevant drivers of outcomes. These insights will guide further exploration and the identification of novel approaches to address this challenging disease.