Endocyte Announces Enrollment of First Patient in Phase 3 VISION Trial of 177Lu-PSMA-617 in Prostate Cancer
June 05 2018 - 8:01AM
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company
developing targeted therapeutics for personalized cancer treatment,
today announced the enrollment of the first patient in its global
phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr.
Luke Nordquist at Urology Cancer Center in Omaha, NE, a member of
Precision Cancer Research. The international,
prospective, open-label, multicenter, randomized phase 3 study is
evaluating patients with progressive prostate specific membrane
antigen (PSMA)-positive metastatic castration-resistant prostate
cancer (mCRPC), who have received at least one novel androgen axis
drug (abiraterone or enzalutamide) and at least one taxane regimen.
“We are pleased to announce the initiation of this important
clinical trial so quickly following our end-of-phase 2 meeting with
the FDA. This speed of execution is a result of the enthusiasm of
participating physicians and the focus and urgency of our clinical
operations team,” said Mike Sherman, president and CEO of Endocyte.
“Having collaborated with several of the key opinion leaders in
prostate cancer around the world, we are confident in the
robustness of the VISION trial design and eager to complete
enrollment.”
“In spite of the introduction of new drugs in the last several
years, there continues to be a significant need for therapeutic
alternatives with new mechanisms of action for men suffering from
metastatic castration-resistant prostate cancer,” said Oliver
Sartor, M.D., Medical Director of the Tulane Cancer Center. “The
data generated with 177Lu-PSMA-617 in early clinical trials have
yielded a high level of enthusiasm among physicians. There is a
real need to advance this investigational therapy as quickly as
possible for these heavily pre-treated patients and begin the work
to evaluate it in earlier lines of therapy, particularly in advance
of chemotherapy.”
Phase 2 Clinical Data Presented at ASCO
Incremental data from an expansion cohort of 20 patients
recently presented at ASCO confirmed and improved upon PSA response
to 177Lu-PSMA-617 previously reported in a cohort of 30 patients
enrolled in a phase 2 trial at the Peter MacCallum Cancer Centre in
Melbourne, Australia.
“Twenty-six of the 50 patients (52%) enrolled in this trial are
more heavily pre-treated than the minimum eligibility criteria for
the VISION trial, so it is particularly compelling to see a PSA
decline of 50% or more in 62% of these advanced patients and a
median PSA progression-free survival (PFS) of 7.0 months,” said
Alison Armour, chief medical officer of Endocyte. “While the
overall survival data are not yet mature for the second cohort of
20 patients, we were pleased to see six-month survival rates
similar to the first cohort of 30 patients. Consistent response
rates across patient groups with variations in prior therapy is
likely a result of a potential differentiated mechanism of action
for 177Lu-PSA-617 compared to currently approved
therapies.”
177Lu-PSMA-617 was generally well tolerated, with no significant
dose-limiting toxicities observed. The most common
treatment-related toxicity was Grade 1-2 xerostomia (dry mouth)
seen in 68% of patients, but infrequently required any
intervention. The occurrence of treatment-related Grade 3-4
hematologic toxicity was low and comparable to the largest
retrospective published cohort.
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 investigator, may include 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 primary endpoint of the study agreed to by
the FDA is overall survival (OS). Secondary endpoints include
radiographic progression-free survival (rPFS), response evaluation
criteria in solid tumors (RECIST) response, and time to first
symptomatic skeletal event. Two interim efficacy analyses of OS
will be conducted at 50% and 70% of the first 489 targeted events.
Endocyte plans to discuss modifying the first interim analysis
endpoint to rPFS to expedite a potential accelerated approval in
the U.S. Further information on the global Phase 3 VISION
study can be found at www.VISIONClinicalTrial.com.
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 the company’s 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.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing
targeted therapies for the personalized treatment of cancer. The
company's drug conjugation technology targets therapeutics and
companion imaging agents specifically to the site of diseased
cells. Endocyte's lead program is a prostate specific membrane
antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617,
entering phase 3 for metastatic castration-resistant prostate
cancer (mCRPC). Endocyte also expects to have an Investigational
New Drug application submitted in the fourth quarter of 2018 for
its adaptor-controlled CAR T-cell therapy which will be initially
studied in osteosarcoma. For additional information, please visit
Endocyte's website at www.endocyte.com.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company's
future development plans including those relating to the completion
of pre-clinical development in preparation for possible future
clinical trials, the initiation of a registration trial, and
preparation for potential commercialization. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include risks that the company or independent
investigators may experience delays in the initiation or completion
of clinical trials (whether caused by competition, adverse events,
patient enrollment rates, shortage of clinical trial materials,
regulatory issues or other factors); risks that data from prior
clinical trials may not be indicative of subsequent clinical trial
results; risks related to the safety and efficacy of the company’s
product candidates; risks that early stage pre-clinical data may
not be indicative of subsequent data when expanded to additional
pre-clinical models or to subsequent clinical data; risks that
evolving competitive activity and intellectual property landscape
may impair the company's ability to capture value for the
technology; risks that expectations and estimates turn out to be
incorrect, including estimates of the potential global markets for
the company’s product candidates, estimates of the availability and
capacity of manufacturing and other facilities required to support
its product candidates, projected cash needs, and expected future
revenues, operations, expenditures and cash position. More
information about the risks and uncertainties faced by Endocyte,
Inc. is contained in the company’s periodic reports filed with the
Securities and Exchange Commission. Endocyte, Inc. disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Contact:Stephanie Ascher, Stern
Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
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