The Cancer Letter

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Clinical Roundup

Phase III cancer vaccine trial meets primary endpoint

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The primary endpoint was met in a predefined step-1 analysis of a phase III trial in non-small cell lung cancer patients treated with Tedopi, a neoepitope cancer vaccine.

Data showed a 12 month-survival rate of 46% for patients treated with Tedopi versus 36% for patients in the chemotherapy control arm. Enrollment in the Step-2 portion of the phase III trial have been stopped due to concerns over COVID-19.

Instead, there will be further analysis of step-1 data in parallel with discussions with regulatory agencies on a pathway to approval.

Tedopi is being developed in a phase 3 trial in NSCLC for patients who have failed to respond on PD1/PDL1 checkpoint inhibitor treatments, the current standard of care. About 30% of NSCLC patients don’t respond to checkpoint inhibitors and this patient population lacks approved treatment options. Tedopi is also currently being explored in a phase II trial in pancreatic cancer.

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