On September 10, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that following a meeting with the U.S. Food and Drug Administration (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 (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Endocyte, SEP 10, 2018, View Source [SID1234529396]).

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"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," said Mike Sherman, president and CEO of Endocyte. "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."

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. If 177Lu-PSMA-617 meets the primary endpoint in the rPFS assessment, no unexpected safety issues arise, and it demonstrates no detriment in OS relative to the control arm, Endocyte intends to submit an NDA to seek full approval in the United States. The rPFS analysis will include approximately 450 rPFS events. Regardless of the outcome of the rPFS assessment, Endocyte intends to continue to follow patients in the VISION trial in order to assess the final OS alternative primary endpoint. Other aspects of the trial, including patient treatment and assessments, trial size, overall duration, and follow up remain unchanged. The acceptance of rPFS as a primary endpoint for full approval in Europe will be determined in upcoming regulatory interactions.

VISION Phase 3 Trial Design

VISION will enroll up to 750 patients worldwide with PSMA-positive scans, randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care versus best supportive/best standard of care alone. Best supportive/best standard of care is palliative in nature and, at the discretion of the clinical trial investigator, may include a novel anti-androgen drug such as enzalutamide or abiraterone. Patients treated with 177Lu-PSMA-617 will receive 7.4 gigabecquerel (GBq) intravenously every six weeks for a maximum of six cycles.

The alternative primary endpoints of the trial agreed to by the FDA are radiographic progression-free survival (rPFS) and overall survival (OS). A positive assessment on either is sufficient for full approval. In the case of the rPFS assessment, a corresponding assessment of OS will be made to ensure no detriment in OS has occurred. Secondary endpoints include response evaluation criteria in solid tumors (RECIST) response and time to first symptomatic skeletal event. An efficacy analysis of rPFS and OS will be conducted at approximately 450 and 490 events, respectively. Further information on the global phase 3 VISION trial can be found at View Source

Conference Call

Endocyte management will host a conference call today at 8:30 a.m. EDT.

U.S. and Canadian participants: (877) 845-0711
International participants: (760) 298-5081

A live, listen-only webcast of the conference call may be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com

The webcast will be recorded and available on the company’s website for 90 days following the call.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.