Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival

Endocyte

10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval.

Endocyte, today announced that following a meeting with the U.S. FDA, it was determined that rPFS is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

Under the updated VISION trial design, the two interim assessments previously planned at 50% and 70% of OS events will be replaced with a single assessment of rPFS. This assessment is expected to occur at approximately the same time that the first interim OS assessment would have occurred under the prior trial design and shortly after the time the trial is fully enrolled.

Read Endocyte press release

Michael Wonder

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Michael Wonder