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.
A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply
Warning: This is not a public health recommendation. Do not implement.