− Post-hoc evaluation from Blue Earth Diagnostics’ Phase 3 SPOTLIGHT trial offers information about therapy planning, significantly when healing salvage remedy is taken into account –
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MONROE TOWNSHIP, N.J. & OXFORD, England, October 02, 2023–(BUSINESS WIRE)–Blue Earth Diagnostics, a Bracco firm and acknowledged chief within the improvement and commercialization of progressive positron emission tomography (PET) radiopharmaceuticals, immediately introduced outcomes from a post-hoc evaluation from the Phase 3 SPOTLIGHT trial (NCT04186845) that investigated the usage of POSLUMA® (flotufolastat F 18) PET in suspected biochemical recurrence of prostate most cancers. The evaluation examined the detection charge (% constructive PET scans) in a subset of sufferers with low-very low Prostate Specific Antigen (PSA) ranges. POSLUMA® (flotufolastat F 18) injection (previously known as 18F-rhPSMA-7.3) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) constructive lesions in males with prostate most cancers with suspected metastasis who’re candidates for preliminary definitive remedy or with suspected recurrence based mostly on elevated serum prostate-specific antigen (PSA) stage.
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POSLUMA® (flotufolastat F 18) PET/CT picture exhibiting uptake within the prostate mattress, in step with recurrent prostate most cancers Photo courtesy of Blue Earth Diagnostics
Results highlights:
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Overall, 68% (128/188) of evaluable sufferers with a PSA stage of <1 ng/mL, 76% (51/67) of sufferers with a PSA of ≥0.5 – <1 ng/mL, and 64% (77/121) of sufferers with a PSA <0.5 ng/mL had a constructive flotufolastat F 18 scan by majority learn.
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Extrapelvic lesions had been noticed in 21% (25/121) of sufferers with a PSA <0.5 ng/mL, rising to 39% (26/67) in sufferers with a PSA of ≥0.5 to 1 ng/mL.
“Recurrent prostate most cancers presents scientific challenges, and the flexibility to find out the extent and placement of recurrent illness is critical to tell physicians and their sufferers for applicable scientific administration,” mentioned Ashesh B. Jani, MD, MSEE, FASTRO, Winship Cancer Institute of Emory University, Atlanta, Ga., on behalf of the SPOTLIGHT Study Group. “The SPOTLIGHT research investigated the diagnostic efficiency of POSLUMA PET imaging as a possible decision-making assist in assessing suspected biochemical recurrence of the illness, and demonstrated precision diagnostic efficiency, with an general 83% (322/389) detection charge. This post-hoc evaluation additional examined POSLUMA efficiency in 188 males with low-very low PSA ranges. Results confirmed that greater than two-thirds of those males had been discovered to have constructive POSLUMA scans, with 1 / 4 of them having extrapelvic lesions. POSLUMA PET could also be a great tool for therapy planning, significantly in sufferers with suspected early recurrence of illness who could also be candidates for healing salvage remedy.”
“We are happy to current these outcomes to the radiation oncology group at ASTRO,” mentioned David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA has lately been added to nationally acknowledged scientific oncology tips for prostate most cancers, alongside and for all the identical classes as the opposite presently FDA-approved PSMA PET radiopharmaceuticals. Our new product represents a brand new class of high-affinity PSMA-targeted radiopharmaceuticals based mostly on novel radiohybrid know-how and offers physicians with high-quality info based mostly on these good detection charges at low PSA ranges, high-affinity PSMA binding and low urinary bladder exercise. The product is labeled with the radioisotope fluorine-18 (18F) to leverage excessive picture high quality and to allow broad, readily available geographic access for sufferers by way of the manufacturing and distribution community of our industrial U.S. producer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.”
The findings had been mentioned in an oral presentation on the 2023 ASTRO Annual Meeting on October 2, 2023, “Detection Rate of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence at PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study,” by Ashesh B. Jani, MD, MSEE, FASTRO, Winship Cancer Institute of Emory University, Atlanta, Ga., on behalf of the SPOTLIGHT Study Group. Full session particulars and the summary are available within the ASTRO on-line program here.
About the research
The post-hoc evaluation of SPOTLIGHT information decided flotufolastat F 18 detection charges (DR) at low-very low PSA ranges. Patients enrolled in SPOTLIGHT underwent PET with scans evaluated by majority learn of three blinded central readers. For the current evaluation, all sufferers with an evaluable flotufolastat F 18 PET and a baseline PSA <1 ng/mL had been chosen. Overall (patient-level) and regional DR by majority learn had been decided, stratifying DR in line with the sufferers’ baseline PSA stage (<0.2, ≥0.2 – <0.3, ≥0.3 – <0.5, and ≥0.5 – <1 ng/mL).
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In complete, 389 sufferers (median [range] PSA, 1.10 [0.03–135] ng/mL, 84 with intact prostate) had an evaluable flotufolastat F 18 scan. The general DR was 83% (322/389) by majority learn. Of the 389 sufferers with an evaluable flotufolastat F 18 scan, 188 had a baseline PSA <1 ng/mL and had been eligible for the current evaluation. Despite low affected person numbers in some PSA classes, reasonable to excessive DR had been noticed, with the patient-level DR proven to extend with rising baseline PSA. Overall, 68% (128/188) of sufferers with a PSA <1 ng/mL and 64% (77/121) of sufferers with a PSA <0.5 ng/mL had a constructive flotufolastat F 18 scan by majority learn. Regional DRs had been broadly constant throughout all PSA classes. Extrapelvic lesions had been noticed in 21% (25/121) of sufferers with a PSA <0.5 ng/mL, rising to 39% (26/67) in sufferers with a PSA of ≥0.5 to 1 ng/mL.
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No critical antagonistic reactions had been attributed to flotufolastat F 18 within the SPOTLIGHT research. Overall, 16 (4.1%) sufferers had no less than one treatment-emergent antagonistic occasion that was thought of presumably associated/associated to flotufolastat F 18. The most often reported occasions had been: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection web site response: 0.5% (n=2), and headache: 0.5% (n=2).
About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds include a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate most cancers cells, and so they could also be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – offering the potential for creating a real theranostic know-how. Radiohybrid know-how and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired unique, worldwide rights to rhPSMA diagnostic imaging know-how from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic software to its sister firm Blue Earth Therapeutics. Blue Earth Diagnostics acquired U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product to be used in prostate most cancers in 2023. rhPSMA compounds for potential therapeutic use are investigational and haven’t acquired regulatory approval.
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) constructive lesions in males with prostate most cancers
IMPORTANT SAFETY INFORMATION
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Image interpretation errors can happen with POSLUMA PET. A damaging picture doesn’t rule out the presence of prostate most cancers and a constructive picture doesn’t affirm the presence of prostate most cancers. The efficiency of POSLUMA for imaging metastatic pelvic lymph nodes in sufferers previous to preliminary definitive remedy appears to be affected by serum PSA ranges and danger grouping. The efficiency of POSLUMA for imaging sufferers with biochemical proof of recurrence of prostate most cancers appears to be affected by serum PSA ranges. Flotufolastat F 18 uptake will not be particular for prostate most cancers and should happen in different varieties of most cancers, in non-malignant processes, and in regular tissues. Clinical correlation, which can embrace histopathological analysis, is really useful.
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Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET might differ relying on imaging readers, significantly within the prostate/prostate mattress area. Because of the related danger of false constructive interpretation, take into account multidisciplinary session and histopathological affirmation when scientific decision-making hinges on flotufolastat F 18 uptake solely within the prostate/prostate mattress area or solely on uptake interpreted as borderline.
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POSLUMA use contributes to a affected person’s general long-term cumulative radiation publicity. Long-term cumulative radiation publicity is related to an elevated danger for most cancers. Advise sufferers to hydrate earlier than and after administration and to void often after administration. Ensure protected dealing with to reduce radiation publicity to the affected person and well being care suppliers.
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The antagonistic reactions reported in ≥0.4% of sufferers in scientific research had been diarrhea, blood strain improve and injection web site ache.
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Drug Interactions: androgen deprivation remedy (ADT) and different therapies focusing on the androgen pathway, resembling androgen receptor antagonists, might lead to adjustments in uptake of flotufolastat F 18 in prostate most cancers. The impact of those therapies on efficiency of POSLUMA PET has not been established.
To report suspected antagonistic reactions to POSLUMA, name 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full POSLUMA prescribing info is available at www.posluma.com/prescribing-information.pdf.
About Blue Earth Diagnostics
Blue Earth Diagnostics, an oblique subsidiary of Bracco Imaging S.p.A., is a rising worldwide molecular imaging firm centered on delivering progressive, well-differentiated diagnostic options that inform affected person care. Formed in 2014, the Company’s success is pushed by its administration experience and supported by a demonstrated monitor file of speedy improvement and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ increasing oncology portfolio encompasses a wide range of illness states, together with prostate most cancers and neuro-oncology. Blue Earth Diagnostics is dedicated to the well timed improvement and commercialization of precision radiopharmaceuticals for potential use in imaging and remedy. For extra info, please go to: www.blueearthdiagnostics.com.
About Bracco Imaging
Bracco Imaging S.p.A., a part of the Bracco Group, is a world-leading diagnostic imaging supplier. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging brokers and options. It presents a product and answer portfolio for all key diagnostic imaging modalities: X-ray imaging (together with Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine by radioactive tracers and novel PET imaging brokers to tell scientific administration and information take care of most cancers sufferers in areas of unmet medical want. Our regularly evolving portfolio is accomplished by a variety of medical units, superior administration programs and dose-management software program. In 2019 Bracco Imaging enriched its product portfolio by increasing the vary of oncology nuclear imaging options within the urology phase and different specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology car to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.
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Contacts
For Blue Earth Diagnostics (U.S.)
Priscilla Harlan
Vice President, Corporate Communications
(M) (781) 799-7917
[email protected]
For Blue Earth Diagnostics (UK)
Clare Gidley
Associate Director Marketing and Communications
Tel: +44 (0) 7917 536939
[email protected]
Media
Sam Brown Inc.
Mike Beyer
(M) (312) 961-2502
[email protected]
