Following discussions with the FDA, Polaris will cease its Phase III study for pleural mesothelioma based on recommendations from the Data and Safety Monitoring Board (DSMB), due to current success and difficulties in continuing recruitment.
On April 26, 2021, the DSMB advised Polaris to engage with regulatory authorities to consider concluding enrollment within the next three months while continuing one-year follow-up for enrolled subjects. Their recommendation was based on the success criteria strength of an overall survival rate exceeding 80% at the interim analysis, along with challenges associated with competitive therapies and the unknown impact of COVID-19 on enrollment and follow-up.
Polaris contacted the FDA regarding this DSMB recommendation. The FDA responded in a letter dated July 26, 2021, expressing no objection to following this recommendation. Consequently, Polaris will conclude study enrollment in mid-August 2021 and conduct a one-year follow-up of participants.
Polaris acknowledges certain risks associated with early study termination. However, Polaris is encouraged by the high probability of study success indicated by the DSMB.