RE:RE:RE:How does Accelerated Approval work A primary endpoint for ONCY'S Phase 2 metastatic breast cancer (Bracelet-1) of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June 2024. The effect of having extended data on OS should make for even more ccompelling request for an FDA Accelerated Approval for pelareorep (monotherapy) + paclitaxel in mBC. By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as exemplified by Pfizer's Paloma and Daichii's Destiny successes. And as ONCY mentioned in several investor presentations, there room for one or two and potentially 3 registration studies to be pursued both in monotherapy and in combination with other I/O agents.
The monotherapy registration study in mBC offers ONCY the freedom to operate and removes any restriction for the company to partner with one Big Pharma company or another. As previously mentioned, an Accelerated Approval results in the creation of a revenue stream for ONCY and an accretive asset for any Big Pharma acquirer of ONCY. And because of this capital opportunity eventually happening, I think that the latter Big Pharma acquisition will happen sooner than later and well before an Accelerated Approval is even announced. And with two Phase 2 clinical trials completed, in metastatic breast cancer, namely IND-213 and Bracelet-1, and a PFS, ORR and mOS reported in Bracelet-1 of 38.2%, 37.5% and a near doubling in median overall survival, respectively, ONCY is the closest to an Accelerated Approval than any other agent in this category of immunomodulators.
Mature overall survival (OS) from the Bracelet-1 study is expected at anytime.which supports an Accelerated Approval request, now that ONCY has guided on a planned adaptive 180-200 patient Phase 2b/ Phase 3/confirmatory clinical trial, that can morph from one Phase to another as an adaptive design provides, and which ONCY is able to conduct on its own.
This notwithstanding ONCY has committed to releasing the mature OS mBC data in H2 2024 ... and making reference in the release that OS may be still maturing but that the current 2 year + OS data has met the mature survival timeline sufficient for the FDA to grant an Accelerated Approval for pelareorep in mBC would be incredibly useful.