Endocyte Inc. (NASDAQ: ECYT) shares made a solid gain early on Monday after the company announced an update from the U.S. Food and Drug Administration (FDA).
After a meeting with the FDA, it was determined that radiographic progression free survival (rPFS) is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application (NDA) 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 overall survival (OS) events will be replaced with a single assessment of rPFS. This assessment is expected to occur at roughly 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.
Should 177Lu-PSMA-617 meet the primary endpoint in the rPFS assessment, with no unexpected safety issues arising and no detriment in OS relative to the control arm, then Endocyte intends to submit an NDA to seek full approval in the United States.
Mike Sherman, president and CEO of Endocyte, commented:
We are very pleased with the FDA’s support of the rPFS endpoint as the basis for a submission for full approval of 177Lu-PSMA-617. This change provides an opportunity to obtain a full approval sooner than we previously anticipated and highlights the Agency’s commitment to addressing the urgent need for a new mechanism of action to treat mCRPC,” “Under the updated protocol, we now expect the analysis of rPFS for potential full approval to occur before the end of 2019. We also retained the final, fully powered OS analysis, which is expected to occur near the end of 2020. This provides two potential paths for approval and preserves a robust OS analysis to support a potential label.
Shares of Endocyte were up more than 7% early Monday at $18.25, with a consensus analyst price target of $20.67 and a 52-week trading range of $1.36 to $20.85.