Post-hoc analysis from Phase 3 SPOTLIGHT trial
demonstrated consistent performance between African Americans and
other patient groups for FDA-approved POSLUMA in men with recurrent
prostate cancer1
Study achieved 17% African American enrollment,
more than twice the average for oncology clinical trials2
Blue Earth Diagnostics, a Bracco company and recognized leader
in the development and commercialization of innovative PET
radiopharmaceuticals, today announced results of a post-hoc
analysis of data from the Phase 3 SPOTLIGHT study (NCT04186845),
which assessed FDA-approved POSLUMA® (flotufolastat F 18) injection
in patients with recurrent prostate cancer.3,4 Based on the high
mortality and prevalence of prostate cancer in African American
men, a sub-analysis was conducted to evaluate the performance of
POSLUMA and the rate of enrollment for African American men in the
trial. Results showed that the detection rate was high among
African American patients, with 93% found to have a positive
POSLUMA scan, consistent with the 87% detection rate for all other
patients in the study.1 The 17% participation of African American
men in the SPOTLIGHT study was twice the enrollment typically
reported in other types of oncology clinical trials (8.5%).1,2 The
manuscript, “18F-Flotufolastat Positron Emission Tomography in
African American Patients with Suspected Prostate Cancer
Recurrence: Findings from the Phase 3 SPOTLIGHT Study” has been
published online in the journal Advances in Radiation Oncology
(https://doi.org/10.1016/j.adro.2024.101571), and will appear in an
upcoming print issue.
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POSLUMA is approved in the United States for positron emission
tomography (PET) of prostate-specific membrane antigen (PSMA)
positive lesions in men with prostate cancer with suspected
metastasis who are candidates for initial definitive therapy or
with suspected recurrence based on elevated serum prostate-specific
antigen (PSA) level.
“Prostate cancer is the most commonly diagnosed cancer among
African American men, who are twice more likely to die from the
disease than White men,”5-7 said Soroush Rais-Bahrami, MD,
Department of Urology, University of Alabama at Birmingham Heersink
School of Medicine, Birmingham, Ala. “It is encouraging that
African American enrollment in the SPOTLIGHT trial closely aligns
with their 14% representation of the U.S. population8, because
results from oncology trials with low diversity populations are
less useful for clinical decision-making and can contribute to
racial disparities in cancer outcomes.”
The U.S. Food and Drug Administration (FDA) has issued draft
guidance on clinical trial diversity and organizations such as the
American Society of Clinical Oncology (ASCO) have called out the
need for enriched diversity in oncology clinical trial
participation.9,10
“Beyond validating the diagnostic performance of POSLUMA in
African American men, findings from the SPOTLIGHT study provide
useful considerations for planning future clinical trials, to
facilitate patient enrollment and achieve clinical trial
diversity,” said Marco Campione, Chief Executive Officer, Blue
Earth Diagnostics. “The results achieved in African American men
were derived from clinical sites across the United States, and
further support the broad applicability of POSLUMA for its
indicated use across the U.S. population as a whole.”
FDA-approved POSLUMA represents a newer class of high-affinity
PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid
technology and leverages the high image quality of 18F-labeled PSMA
PET imaging to help facilitate detection of prostate cancer. It can
provide clinically valuable information to guide patient management
based on its high-affinity PSMA binding, low urinary uptake and
positive performance at very low PSA levels. POSLUMA is included in
nationally recognized clinical oncology guidelines for prostate
cancer, covered by the vast majority of insurance plans and is
readily available for patients across the country through the
network of Blue Earth Diagnostics’ commercial U.S. manufacturer and
distributor, PETNET Solutions Inc, A Siemens Healthineers
Company.
Indication and Important Safety
Information About POSLUMA
INDICATION POSLUMA® (flotufolastat F 18) injection is
indicated for positron emission tomography (PET) of
prostate-specific membrane antigen (PSMA) positive lesions in men
with prostate cancer
- with suspected metastasis who are candidates for initial
definitive therapy
- with suspected recurrence based on elevated serum
prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION
- Image interpretation errors can occur with POSLUMA PET. A
negative image does not rule out the presence of prostate cancer
and a positive image does not confirm the presence of prostate
cancer. The performance of POSLUMA for imaging metastatic pelvic
lymph nodes in patients prior to initial definitive therapy seems
to be affected by serum PSA levels and risk grouping. The
performance of POSLUMA for imaging patients with biochemical
evidence of recurrence of prostate cancer seems to be affected by
serum PSA levels. Flotufolastat F 18 uptake is not specific for
prostate cancer and may occur in other types of cancer, in
non-malignant processes, and in normal tissues. Clinical
correlation, which may include histopathological evaluation, is
recommended.
- Risk of Image Misinterpretation in Patients with Suspected
Prostate Cancer Recurrence: The interpretation of POSLUMA PET may
differ depending on imaging readers, particularly in the
prostate/prostate bed region. Because of the associated risk of
false positive interpretation, consider multidisciplinary
consultation and histopathological confirmation when clinical
decision-making hinges on flotufolastat F 18 uptake only in the
prostate/prostate bed region or only on uptake interpreted as
borderline.
- POSLUMA use contributes to a patient’s overall long-term
cumulative radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk for cancer. Advise
patients to hydrate before and after administration and to void
frequently after administration. Ensure safe handling to minimize
radiation exposure to the patient and health care providers.
- The adverse reactions reported in ≥0.4% of patients in clinical
studies were diarrhea, blood pressure increase and injection site
pain.
- Drug Interactions: androgen deprivation therapy (ADT) and other
therapies targeting the androgen pathway, such as androgen receptor
antagonists, may result in changes in uptake of flotufolastat F 18
in prostate cancer. The effect of these therapies on performance of
POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call
1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Full POSLUMA prescribing information is available at
www.posluma.com/prescribing-information.pdf.
About Blue Earth Diagnostics Blue Earth Diagnostics, an
indirect subsidiary of Bracco Imaging S.p.A., is a growing
international molecular imaging company focused on delivering
innovative, well-differentiated diagnostic solutions that inform
patient care. Formed in 2014, the Company’s success is driven by
its management expertise and supported by a demonstrated track
record of rapid development and commercialization of positron
emission tomography (PET) radiopharmaceuticals. Blue Earth
Diagnostics’ expanding oncology portfolio encompasses a variety of
disease states, including prostate cancer and neuro-oncology. Blue
Earth Diagnostics is committed to the timely development and
commercialization of precision radiopharmaceuticals for potential
use in imaging and therapy. For more information, please visit:
www.blueearthdiagnostics.com.
About Bracco Imaging Bracco Imaging S.p.A., part of the
Bracco Group, is a world-leading diagnostic imaging provider.
Headquartered in Milan, Italy, Bracco Imaging develops,
manufactures and markets diagnostic imaging agents and solutions.
It offers a product and solution portfolio for all key diagnostic
imaging modalities: X-ray imaging (including Computed
Tomography-CT, Interventional Radiology, and Cardiac
Catheterization), Magnetic Resonance Imaging (MRI), Contrast
Enhanced Ultrasound (CEUS), and Nuclear Medicine through
radioactive tracers and novel PET imaging agents to inform clinical
management and guide care for cancer patients in areas of unmet
medical need. Our continually evolving portfolio is completed by a
range of medical devices, advanced administration systems and
dose-management software. In 2019 Bracco Imaging enriched its
product portfolio by expanding the range of oncology nuclear
imaging solutions in the urology segment and other specialties with
the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging
established Blue Earth Therapeutics as a separate, cutting-edge
biotechnology vehicle to develop radiopharmaceutical therapies.
Visit: www.braccoimaging.com.
References 1. Rais-Bahrami S, Fleming M, Gartrell B, et al.
18F-Flotufolastat Positron Emission Tomography in African American
Patients with Suspected Prostate Cancer Recurrence: Findings from
the Phase 3 SPOTLIGHT Study. Adv Clin Onc 2024; doi
10.1016/j.adro.2024.101571 2. Bebi T, Horovitz R, Blum K, et al.
How granularity of data matters in understanding and accelerating
racial diversity in U.S. clinical trials. J Clin Oncol 2022;40
(Suppl 28):88. 3. Jani AB, Ravizzini G, Gartrell BA, et al.
Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in men with
suspected prostate cancer recurrence: Results from a phase 3,
prospective, multicenter study (SPOTLIGHT) J Urol 2023;210:299-311.
4. FDA. Highlights of prescribing information: Posluma
(flotufolastat f 18) injection:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf;
2023. 5. Giaquinto AN, Miller KD, Tossas KY, et al. Cancer
statistics for African American/Black people 2022. CA Cancer J Clin
2022;72:202‐229. 6. Frego N, Labban M, Stone BV, et al. Effect of
type of definitive treatment on race‐based differences in prostate
cancer-specific survival. Prostate 2023;83:1099‐1111. 7.
Rais‐Bahrami S, Zhu Y. Disparities in prostate cancer diagnosis and
management: Recognizing that disparities exist at all junctures
along the prostate cancer journey. Prostate cancer and prostatic
diseases 2023;26:441‐442. 8. Facts About the U.S. Black Population.
Pew Research Center. Fact Sheet. January 14, 2024.
https://www.pewresearch.org/social-trends/fact-sheet/facts-about-the-us-black-population/
9. FDA. Diversity Action Plans to Improve Enrollment of
Participants from Underrepresented Populations in Clinical Studies
https://www.fda.gov/media/179593/download; 2024. 10. Oyer RA,
Hurley P, Boehmer L, et al. Increasing racial and ethnic diversity
in cancer clinical trials: An American Society of Clinical Oncology
and Association of Community Cancer Centers joint research
statement. Journal of Clinical Oncology 2022;40:2163-2171.
POSLUMA is a registered trademark of Blue Earth Diagnostics
Ltd.
This press release is for U.S. audiences only
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For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice
President, Corporate Communications (M) (781) 799-7917
priscilla.harlan@blueearthdx.com
For Blue Earth Diagnostics (UK) Clare Gidley Associate
Director Marketing and Communications Tel: +44 (0)1865 784186
clare.gidley@blueearthdx.com
Media Sam Brown Inc. Mike Beyer (M) (312) 961-2502
mikebeyer@sambrown.com