Radioligand Therapy In Prostate Cancer
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Keywords:prostate cancer, radioligand therapy, treatment, therapy
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Keywords:prostate cancer, radioligand therapy, treatment, therapy
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
Convergent Therapeutics Point Biopharma Pair Antibody Radioligand Therapy In Prostate Cancer Study
NEW YORK Convergent Therapeutics on Tuesday said it will evaluate CONV 01-alpha, a prostate-specific membrane antigen-directed antibody paired with the alpha particle emitter actinium-225, in combination with Point Biopharma’s PSMA radioligand PNT2002 linked to a beta particle emitter lutetium-177 in advanced castration-resistant prostate cancer patients.
The drugmakers are evaluating CONV 01-alpha and PNT2002 in a Phase I/II trial that has already begun enrolling patients at Weill Cornell Medicine. Investigators will enroll up to 33 patients with metastatic castration-resistant prostate cancer that is PSMA-positive by PET imaging. Patients must have progressive disease despite prior treatment with an androgen receptor signaling inhibitor and taxane chemotherapy.
In the Phase I dose-escalation portion, researchers will establish the maximum tolerated dose for CONV 01-alpha, which patients will receive in combination with a dose of PNT2002 that Point established in another ongoing trial, called SPLASH. Then, in the Phase II expansion portion, researchers will track the number of patients who after receiving the combination regimen experience more than a 50 percent decline in prostate-specific antigen levels.
The strategy to couple an antibody with ligand-targeted treatments evolved from research conducted at Weill Cornell Medicine and patented by Cornell University, which Cambridge, Massachusetts-based Convergent exclusively licensed.
Targeted Radioligand Improves Survival In Advanced Prostate Cancer
Cancer researchers say they have established a new, life-extending treatment option for men with prostate cancer that has spread and become resistant to hormone therapy. The injected treatment combines a targeting compound with a radioactive isotope to irradiate and kill cancer cells.
An international clinical trial sponsored by Endocyte, Inc., a Novartis company tested the targeted radioligand therapy in study participants with advanced prostate cancer. All subjects had cancers that had spread to other organs and continued to progress after previous treatment with two kinds of drugs, androgen axis inhibitors and taxanes. The experimental treatment significantly extended survival, delayed progression and was generally well tolerated by study subjects, researchers said.
This is a completely new treatment option that extends life and disease control in metastatic castration-resistant prostate cancer the most aggressive and deadly type, said Tom Beer, M.D., one of the study leaders and deputy director of the Oregon Health & Science University Knight Cancer Institute.
The added option is particularly important, Beer said, because the existing most effective treatments developed for metastatic castration resistant prostate cancer are now being used to treat early-stage disease.
Some of our best treatments are being used earlier, so by the time you get to metastatic castration resistant disease, you have fewer options, he said.
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Why Are Readiness Assessment Frameworks Needed
To create a health system that is ready to adapt to change, we must take a rigorous approach that allows for evidence-based decision-making and proactive policy action.
Frameworks are tools that can be used to help understand and solve complex problems, allowing us to proactively prepare for the future of healthcare. A framework enables us to assess the operations of a health system in a standardised and objective way. It can also help to ensure that people are asking the right questions in regard to health system improvement.
Data generated by applying frameworks can also be used to identify gaps in the provision of care. As the same framework can be applied in different settings, it can also enable comparison and learning within and between countries.
The Health Policy Partnership has developed the Readiness Assessment Framework to evaluate current integration of and readiness for innovative approaches to care across a health system. The framework covers five key domains: governance, regulation and reimbursement, identified need, service provision and health information. Before it is applied, the framework should be adapted to a particular care approach to ensure that the data generated are specific, relevant and useful.
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Fda Grants Priority Review To Targeted Radioligand Therapy For Advanced Prostate Cancer
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The FDA granted priority review to 177Lu-PSMA-617 for treatment of certain men with advanced prostate cancer.
The designation applies to use of 177Lu-PSMA-617 , an investigational targeted radioligand therapy, by men with metastatic castration-resistant disease who received androgen receptor pathway inhibition and taxane-based chemotherapy.
The FDA is expected to make a decision on approval in the first half of 2022.
The agency based the priority review designation on results of the randomized phase 3 VISION study.
As Healio previously reported, results presented during the plenary session of this years virtual ASCO Annual Meeting showed the addition of 177Lu-PSMA-617 to standard care significantly extended OS and radiographic PFS among men with progressive prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.
The FDA previously granted breakthrough therapy designation to 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer.
Also Check: New Drug Prostate Cancer Approved Fda
What Is Health System Readiness
Health system readiness is the ability of a health system to promptly and sustainably adapt its policies, infrastructure and processes to support the integration of innovative approaches to care.
Healthcare is rapidly changing, so it is important that health systems are flexible and able to adapt effectively. Looking at one area of a health system in isolation is not sufficient we must take a holistic approach to ensure that innovative diagnostics and treatments can be integrated into care in a timely manner, and that all people can access the services that could benefit them most.
Mhra Grants Marketing Authorisation For Treatment Of Advanced Prostate Cancer
Advanced Accelerator Applications , a Novartis company, announced that the Medicines & Healthcare products Regulatory Agency has granted marketing authorisation in Great Britain for lutetium vipivotide tetraxetan, for the treatment of adult patients with prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes1.
This follows the positive scientific opinion issued for lutetium vipivotide tetraxetan in April 2022 by the MHRA for the Early Access to Medicines Scheme 7.
Following the granting of this marketing authorisation by the MHRA, Novartis will continue to work with NICE and NHS stakeholders to enable eligible patients in Great Britain to access lutetium vipivotide tetraxetan.
Steve Allen, Acting Chair of Tackle Prostate Cancer, said: Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a 1 in 2 chance of surviving 5 years. This announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families. There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome.
References
1 Pluvicto Summary of Product Characteristics. 2022.
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Predictors Of The Response
Ferdinandus et al. evaluated the prognostic value of various pre-therapeutic parameters on therapy response, based on changes in PSA after the first cycle of RLT. Their multivariate analysis of these parameters, which considered any decrease in PSA after 2 months, showed that patients with a high platelet count or a regular need for analgesics had a significantly worse response to the first RLT cycle. When a PSA decline of 50% was considered, patients with a regular need for analgesics showed a worse response in the multivariate analysis however, other pre-therapeutic parameters had no impact on the response to RLT. In this study, the standard uptake value maximum of 68Ga-PSMA-11 was not a significant predictor of the response to RLT. One explanation for this could be that more aggressive tumours may express higher PSMA levels. However, despite the better uptake of 177Lu-PSMA-617 due to the rapid growth of metastases, the response rate did not correlate with the uptake, which could be due to different washout times of 177Lu-PSMA-617 in the respective metastases .
Targeted Radioligand Therapy Viable For Certain Men With Advanced Prostate Cancer
Hofman MS, et al. Abstract 5000. Presented at: ASCO Annual Meeting June 3-7, 2022 Chicago.
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CHICAGO Lutetium Lu 177 vipivotide tetraxetan is a viable option for certain men with advanced prostate cancer, according to study results presented at ASCO Annual Meeting.
Lutetium Lu 177 vipivotide tetraxetan appeared associated with a higher response rate, greater PFS benefit and better patient-reported outcomes than cabazitaxel for men with metastatic castration-resistant, prostate-specific membrane antigen-positive prostate cancer whose disease progressed after docetaxel and an androgen receptor pathway inhibitor.
OS appeared comparable between the two therapies, results of the TheraP ANZUP 1603 trial showed.
Background and methods
Lutetium Lu 177 vipivotide tetraxetan formerly called 177Lu-PSMA-617 is the first targeted radioligand therapy for treatment of progressive, prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer. PSMA is highly expressed in more than 80% of men with prostate cancer.
The TheraP trial included 200 men with metastatic castration-resistant prostate cancer whose disease progressed after docetaxel.
Eligibility criteria included high PSMA expression defined as at least one site with standard uptake valuemax of 20 or higher and 18F-FDA demonstrating no discordant disease .
Results
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Mhra Grants Marketing Authorisation For Novartis Radioligand Therapy Pluvicto Vipivotide Tetraxetan In Advanced Prostate Cancer In Great Britain
MHRA grants marketing authorisation for Novartis radioligand therapy Pluvicto® vipivotide tetraxetan) in advanced prostate cancer in Great Britain
· Lutetium vipivotide tetraxetanreceived Medicines and Healthcare Products Regulatory Agency authorisation for the treatment of eligible advanced prostate cancer patients in Great Britain1, making it the first region in Europe to receive marketing authorisation.
· Locametz® , a PSMA-targeted positron emission tomography imaging tracer, has also received a licence from the MHRA for use in imaging prostate cancer in Great Britain2 the first diagnostic PSMA imaging tracer to receive this status from the MHRA.
London, August 11, 2022 Advanced Accelerator Applications , a Novartis company, today announced that the Medicines & Healthcare products Regulatory Agency has granted marketing authorisation in Great Britain for lutetium vipivotide tetraxetan, for the treatment of adult patients with prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes1.
This follows the positive scientific opinion issued for lutetium vipivotide tetraxetan in April 2022 by the MHRA for the Early Access to Medicines Scheme 7.
Great Britain.
About Pluvicto® vipivotide tetraxetan)
About Locametz®
About Advanced Accelerator Applications S.A.
About Novartis
Fda Approves Radioactive Treatment For Prostate Cancer
– April 04, 2022
A new treatment option is available for patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer . Novartis announced recently that the U.S. Food and Drug Administration has approved its targeted radioligand therapy Pluvicto.
Novartis announces #FDA approval today of our targeted radioligand therapy for an indication enabling us to reach even more #cancer patients in need. #NovartisNews#reimaginemedicine
Novartis News
This is a major development because this is a first of its kind treatment for cancer in general and prostate cancer specifically, said Dr. Julio Pow-Sang, chair of the Genitourinary Oncology Program at Moffitt Cancer Center. This type of personalized treatment, based on a patients PSMA expression receptor, is a very innovative development, especially for those patients who have already undergone treatment with hormonal therapy and chemotherapy with progression of their cancer. These patients now have an opportunity to benefit from something that wasnt previously available.
“The Radionuclide Therapy Program at Moffitt was heavily involved in the VISION trial, and we are extremely enthusiastic about this approval since our patients can now have a new very efficient treatment option.”
– Dr. Ghassan El-Haddad, Diagnostic Imaging and Interventional Radiology Department
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National Program On Radioligand Therapy For Prostate Cancer
BACKGROUND: New therapeutics are urgently needed to improve the outcome of men with castrate-resistant prostate cancer , a leading cause of cancer-related deaths in Canadian men. Prostate-specific membrane antigen is a known biomarker and therapeutic target for prostate cancer. Radioligand therapy targeting PSMA has shown promising results in mCRPC, and a substantial subset of prostate cancer patients may benefit from this approach. The safety, tolerability, and anti-tumour activity of PSMA RLT in comparison to chemotherapy should be investigated prospectively to evaluate this treatment for Canadian mCRPC patients.
AIMS: Harmonize production and distribution of PSMA radiopharmaceuticals for introduction into Canadian clinical trials and Conduct a randomized Phase 2 trial to compare PSMA RLT with chemotherapy Perform an economic evaluation of RLT for prostate cancer
PI: Francois Bernard
Radioligand Therapy Using Lu
Radioligand therapy using Lu-177 labelled PSMA is a novel and promising therapeutic approach to treat metastatic prostate cancer. We explain how the therapy works.
Lu-177 PSMA Therapy is an emerging therapeutic method for the palliative treatment of advanced metastatic prostate cancer, which is offered as an individual medical treatment. An individual medical treatment is the application of an effective but not approved therapy, which can be carried out in individual cases and in patients where other therapeutic measures have been exhausted. An individual medical treatment is clearly to be differentiated from a clinical trial and is not part of the medical standard of care, as side effects and risks are not yet fully understood. Initial clinical results on Lu-177 PSMA therapy, however, confirm acceptable rates of side effects with good therapeutic results12.
How does the therapy work?
Prostate-derived cancer cells usually have the prostate-specific membrane antigen incorporated in their cell surface. This antigen can act as a magnetic docking site, which can bind so-called PSMA ligands. These ligands can be chemically combined with therapeutically effective beta emitters . This allows the beta emitter to unfold its effect directly on the cancer cell. Since the radioactive radiation only reaches a few mm in human tissue, a higher and therefore more effective dosage of radiation can be applied directly towards the tumor cells compared to radiation therapy from the outside.
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