Oncology medtech Novocure presented data Monday from a non-inferiority study run to meet a requirement mandated as part of FDA's approval of Optune, a tumor treating field device for brain cancer.
In data shared as part of the American Association for Cancer Research's virtual annual meeting, Novocure linked its device to a median overall survival of 7.4 months in patients with recurrent glioblastoma multiforme. Patients treated with best standard of care chemotherapy in Novocure’s pivotal trial had a median overall survival of 6.4 months.
The efficacy data for the post-approval registry trial, coupled to the lack of unexpected adverse events, confirm the profile seen in the pivotal trial and fulfill Novocure’s obligation to FDA under the terms of the approval of Optune, researchers presenting the data said.
Novocure’s pivotal clinical trial failed to show Optune is superior to chemotherapy in patients with recurrent GBM, a form of brain cancer. However, with Optune holding its own, achieving a median overall survival of 6.6 months, FDA concluded the benefits of the device outweighed the risks, leading it to approve the product for use as a monotherapy in recurrent GBM.
In conjunction with the approval, FDA asked Novocure to run a postapproval study to confirm the efficacy of Optune in real-world use. The protocol accepted by FDA in 2016 set Novocure up to meet that obligation by enrolling patients through a registry it sponsors and comparing the results to the control arm of the pivotal trial.
The headline finding in the data presented at AACR is the 7.4-month median OS among patients who received Optune. Based on the data, the researchers said “the results show a significant superiority [hazard ratio] of overall survival.”
The researchers also presented results from the subset of patients who received at least one course of treatment with Optune or chemotherapy. In that analysis, the median OS for Optune patients was 8.1 months, compared to 6.5 months in the chemotherapy cohort. Time to treatment failure in the Optune and chemotherapy arms was 3.3 months and 1.6 months, respectively.
Numerically, the median OS in the postapproval Optune study was greater than in the pivotal trial, although there were reasons to think that would be the case. A subgroup analysis of the pivotal trial linked the use of Optune for more than 18 hours a day with a median OS of 7.7 months, compared to 4.5 months in patients who used the device for shorter periods. All participants in the postapproval trial were supposed to use Optune for upward of 18 hours a day.
The data were shared in one of five presentations related to Optune at the virtual event. The other presentations covered topics including a Phase 2 trial to assess targeted skull remodeling surgery with tumor treating fields in recurrent GBM patients. Investigators filed to run the study earlier this year but the timeline of that study and others involving Optune are now uncertain, with Novocure warning earlier this month that “COVID-19 related challenges are leading to delays in enrollment.”