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Polaris-Press Release-FDA Response to DSMB Recommendation-5 August 2021

After consultation with FDA, Polaris will follow Data and Safety Monitoring Board’s (DSMB) recommendation to stop Phase III study in lung mesothelioma due to current success and difficulty in continued enrollment.

The DSMB recommended on 26 April 2021 that Polaris contact regulatory authorities to consider ending enrollment within the next three months and continue subject follow-up for one year. Their recommendation was based on the conditional power for success being >80% for overall survival at interim analysis, as well as the challenges associated with competing treatments and unknown COVID-19 impact on enrollment and follow-up.

Polaris contacted the FDA regarding this DSMB recommendation. The FDA responded in a 26 July 2021 letter and did not disagree with following this recommendation. Polaris is thus ending study enrollment in the middle of August 2021 and will follow-up subjects for one year.

Polaris acknowledges there is a risk in stopping the study early. However, Polaris is encouraged by the high chance of study success noted by the DSMB.

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