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Blue Earth Diagnostics Announces Results of Additional Analyses from LOCATE Trial Evaluating Change in Recurrent Prostate Cancer Management Following Axumin® (Fluciclovine F 18) PET/CT Imaging

May 6, 2019 Off By BusinessWire

– Presentations at AUA2019 explore Axumin detection rate and
relationship to PSA levels, based on extent of recurrence and prior
treatment –

BURLINGTON, Mass. & OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced results of additional analyses from the LOCATE clinical trial
(NCT02680041) in two presentations at the American Urological
Association’s 2019 Annual Meeting, AUA2019, May 3-6, 2019 in Chicago,
Ill. The LOCATE trial was a prospective, U.S., multicenter, open-label
study investigating the impact of ¹⁸F-fluciclovine PET/CT
imaging on patient management of biochemically recurrent prostate cancer
after initial prostate cancer treatment and negative or equivocal
findings on standard-of-care imaging.

An oral presentation summarized LOCATE study results describing the
sites of suspected recurrent prostate cancer in 213 patients,
according to PSA levels, to investigate the potential for ¹⁸F-fluciclovine
PET/CT to evaluate oligometastatic disease (evidence of limited
recurrent disease potentially amenable to local treatment). Results
indicated that patient level and pelvic region detection rates were
broadly proportional to baseline PSA, with clinically important
detection noted in pelvic nodes (9.3%), retroperitoneal nodes (5.6%)
and bone (6.5%). In total, 25% (53/213) patients had oligometastatic
disease. Twenty (38%) of the oligometastatic patients had PSA ≤ 1.0
ng/mL.
A poster presentation detailed LOCATE study results which evaluated
the detection rate (DR) of ¹⁸F-fluciclovine PET/CT in men
with prostate cancer recurrence with or without radical prostatectomy
(RP). The overall DR for ¹⁸F-fluciclovine PET/CT was 57%
(122/213) and was broadly proportional to the pre-scan PSA level,
ranging from 31% (25/81) to 95% (18/19) among patients with a PSA of
more than 10ng/mL.

Axumin^® (fluciclovine F 18 injection) is an FDA-approved
molecular imaging agent for use in positron emission tomography (PET)
imaging in men with suspected prostate cancer recurrence based on
elevated blood levels of prostate specific antigen (PSA) following prior
treatment. (For additional product information please see the end of
this news release.)

“In line with our mission to develop and commercialize innovative PET
imaging agents for cancer, Blue Earth Diagnostics conducted the
U.S.-based LOCATE study to evaluate the utility of ¹⁸F-fluciclovine
PET/CT in providing physicians with actionable information for the
management of men with recurrent prostate cancer,” said Jonathan Allis,
D. Phil., CEO of Blue Earth Diagnostics. “We are very pleased to share
results from additional analyses of the LOCATE study with the
prestigious urology community at AUA2019.”

“The LOCATE study evaluated men with biochemically recurrent prostate
cancer who had conventional imaging scans which were either negative or
equivocal, and compared their treatment plans before and after ¹⁸F-fluciclovine
PET/CT to assess whether or not it impacted their management,” said
Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and
Chief of Urologic Surgery at Washington University School of Medicine in
St. Louis and lead author on behalf of the LOCATE study group. “Results
of the study indicated an overall detection rate of 57% (122/213) for ¹⁸F-fluciclovine
PET/CT in identifying lesions, that increases with increasing PSA and is
higher among patients with intact prostate than those had previously
undergone radical prostatectomy. As well, pelvic region detection rates
were broadly proportional to baseline PSA.”

Dr. Andriole continued, “Prostate cancer will recur in up to 30% of
patients after initial treatment. In this study, for example, 25%
(53/213) of patients had oligometastatic disease, with 38% (20/53)
having PSA levels of less than or equal to 1.0 ng/mL. The ability to
determine the extent and location of recurrent prostate cancer, in
conjunction with other available clinical information, can inform the
management plan for men with recurrent disease.”

About the LOCATE ¹⁸F-fluciclovine PET/CT
Presentations at AUA2019
Sites of prostate cancer recurrence
delineated with ¹⁸F-fluciclovine positron
emission tomography in patients with negative or equivocal conventional
imaging
The oral presentation characterized sites of recurrence
according to PSA using data from LOCATE, and explored the potential for ¹⁸F-fluciclovine
PET/CT to evaluate oligometastatic disease. Eligible men underwent ¹⁸F-fluciclovine
PET/CT according to standard protocols, with results for 213 patients
stratified by baseline PSA levels. Oligometastatic disease was defined
as 1–5 extraprostatic lesions (≤ 3 lesions in any single organ system)
in men with negative prostate/bed imaging (as a surrogate for primary
tumor control). ¹⁸F-fluciclovine PET/CT detected lesions in
57% (122/213) of men. Patient level and pelvic region detection rates
were broadly proportional to baseline PSA. At PSA < 1.0 ng/mL,
substantial detection was noted in pelvic nodes at a rate of 9.3%
(10/107), in retroperitoneal nodes at a rate of 5.6% (6/107) and in bone
at a rate of 6.5% (7/107). In total, 53/213 (25%) had oligometastatic
disease; 52 (24%) with 1–3 metastases and 1 (0.5%) with 5 metastases.
Twenty (38%) of the oligometastatic patients had PSA ≤ 1.0 ng/mL.

Localization of recurrence of prostate cancer with ¹⁸F-fluciclovine
positron emission tomography in patients with and without prior
prostatectomy: Results from LOCATE
The poster presentation
described data from the LOCATE study to evaluate the detection rate (DR)
of ¹⁸F-fluciclovine PET/CT in men with prostate cancer
recurrence with or without radical prostatectomy (RP). Eligible men
underwent ¹⁸F-fluciclovine PET/CT imaging according to
standard protocol at one of 15 U.S. centers. Scan findings for 213
patients were stratified according to patients’ prior therapy and
baseline characteristics. In total, 164/213 (77%) men had RP prior to
enrollment. PSA levels ranged more widely among the prior RP group
compared with the intact prostate group, although the intact prostate
group had a higher median PSA. ¹⁸F-Fluciclovine-avid lesions
were found in 122 (57%) men, with a DR of 49% (81/164) in men with prior
RP and 84% (41/49) in the intact prostate group. The overall DR was
broadly proportional to the pre-scan PSA and ranged from 31% among those
with a PSA < 0.5 ng/mL to 95% among patients with a PSA > 10 ng/mL. In
the prior prostatectomy group, the DR ranged from 31% at PSA < 0.5 ng/mL
to 95% at PSA > 10 ng/mL. In this cohort of men with PSA-recurrence but
negative/equivocal standard imaging, the majority were shown to have one
or more lesion by ¹⁸F-fluciclovine PET/CT. The DR increased
with increasing PSA and was higher among patients with intact prostate
than those who had previously undergone RP.

About the LOCATE Trial

Blue Earth Diagnostics’ investigational LOCATE study (“The Impact of ¹⁸F
Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on
Management of Patients with Rising PSA (Prostate-specific Antigen) After
Initial Prostate Cancer Treatment”), was a U.S. multi-center study
investigating the impact of ¹⁸F fluciclovine PET/CT imaging
on the management of patients with rising PSA after initial prostate
cancer treatment. The clinical utility of ¹⁸F fluciclovine
PET/CT imaging was assessed by the change from initial management
recommendation to the treatment plan after scanning with ¹⁸F
fluciclovine PET/CT. Additional information about the LOCATE trial is
available at: www.clinicaltrials.gov
(NCT02680041).

U.S. Indication and Important Safety
Information About Axumin

INDICATION

Axumin^® (fluciclovine F 18) injection is indicated for
positron emission tomography (PET) imaging in men with suspected
prostate cancer recurrence based on elevated blood prostate specific
antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A
negative image does not rule out recurrent prostate cancer and a
positive image does not confirm its presence. The performance of
Axumin seems to be affected by PSA levels. Axumin uptake may occur
with other cancers and benign prostatic hypertrophy in primary
prostate cancer. Clinical correlation, which may include
histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in
patients who receive Axumin. Emergency resuscitation equipment and
personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative
radiation exposure, which is associated with an increased risk of
cancer. Safe handling practices should be used to minimize radiation
exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical
studies with Axumin. The most common adverse reactions were injection
site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1
(1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin^® (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for
use in positron emission tomography (PET) imaging to identify suspected
sites of prostate cancer recurrence in men. Recurrence of prostate
cancer is suspected by an increase in prostate specific antigen (PSA)
levels following prior treatment. PET imaging with Axumin may identify
the location and extent of such recurrence. Axumin was developed to
enable visualization of the increased amino acid transport that occurs
in many cancers, including prostate cancer. It consists of a synthetic
amino acid that is preferentially taken up by prostate cancer cells
compared with surrounding normal tissues, and is labeled with the
radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at
Emory University in Atlanta, Ga., with much of the fundamental clinical
development work carried out by physicians at Emory University’s
Department of Radiology and Imaging Sciences. Axumin was approved by the
U.S. Food and Drug Administration in May 2016, following Priority
Review, and is the first product commercialized by Blue Earth
Diagnostics, which licensed the product from GE Healthcare. The molecule
is being investigated by Blue Earth Diagnostics for other potential
cancer indications, such as glioma.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics
company focused on the development and commercialization of novel PET
imaging agents to inform clinical management and guide care for cancer
patients in areas of unmet medical need. Formed in 2014, Blue Earth
Diagnostics is led by recognized experts in the clinical development and
commercialization of innovative nuclear medicine products. The company’s
first approved and commercially available product is Axumin^®
(fluciclovine F 18), a novel molecular imaging agent approved in the
United States and European Union for use in PET imaging to detect and
localize prostate cancer in men with a diagnosis of biochemical
recurrence. The company’s pipeline includes Prostate Specific Membrane
Antigen (PSMA)-targeted radiohybrid (“rh”) agents. rhPSMA is a
clinical-stage, investigational class of theranostic compounds, with
potential applications in both the imaging and treatment of prostate
cancer. Blue Earth Diagnostics is backed by Syncona, an
investment company listed on the London Stock Exchange (LON: SYNC). For
more information, visit: www.blueearthdiagnostics.com.