225Ac-PSMA-Trillium (BAY 3563254) is an investigational next-generation PSMA-targeted alpha therapy with potential to treat patients with advanced metastatic prostate cancer
Prostate cancer is the second most commonly diagnosed cancer in men1, with less than three years median survival among metastatic patients, who have developed castration-resistance2
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excellent.
About Targeted Alpha Therapy
Targeted alpha therapy is an emerging class of radionuclide therapy that can be used against a variety of tumors. It is designed to deliver alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties. This localized delivery of the radioactive payload induces difficult to repair double-strand DNA breaks in tumor cells; damage that can cause cell cycle arrest or cell death. At the same time, because the energy does not travel very far, there is a potential for reduced damage to nearby normal tissues.
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In the study, a total of 488 men with mCRPC and PSMA-avidity in tumour lesions demonstrated on PET or single-photon emission computed tomography (SPECT) imaging, received 8 MBq of 225Ac-PSMA RLT administered intravenously every 8 weeks until disease remission, disease progression, death or patient withdrawal from treatment, at seven centres in Australia, India, Germany and South Africa. All patients had received previous lines of therapy including taxane-based chemotherapy, androgen- receptor-axis inhibitors, 177Lu-PSMA RLT and radium-223 dichloride. In the study, 225Ac-PSMA RLT was administered as a last-line therapy option in 91% of patients because they had exhausted or were ineligible for other treatments.
At a median follow-up of 9 months, the median overall survival (OS) was 15.5 months (95% CI 13.4–18.3) and median progression-free survival (PFS) was 7.9 months (95% CI 6.8–8.9). Levels of prostate-specific antigen (PSA) decreased in 73% of patients after receiving at least one cycle of 225Ac-PSMA RLT, and a PSA decline of 50% or more was reported in 57% of patients.
Overall, 225Ac-PSMA RLT showed a manageable toxicity profile, with xerostomia emerging as a common adverse advent after the first cycle of treatment (n=236) and grade 3 or higher anaemia was seen in 13%, leukopenia in 4%, and thrombo-cytopenia in 7% of patients.
225Ac emits several alpha particles in its decay scheme that are much more energetic than the beta particles emitted by 177Lu, thus suggesting a stronger effect for killing tumour cells, and may be a novel treatment option for patients progressing on prior therapies including 177Lu-PSMA-617. Prospective trials are now needed to validate the safety and survival benefits of 225Ac-PSMA RLT in patients with mCRPC.
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Father, 68 diagnosed with advanced metastatic prostate cancer in March 2018
