Home » Innovative treatments for prostate cancer! PSMA Targeted Ligand Radiotherapy 177Lu-PSMA-617 Phase III Study Successfully: Significantly Extend Patients’ Life!-Novartis Zone-Biology Valley

Innovative treatments for prostate cancer! PSMA Targeted Ligand Radiotherapy 177Lu-PSMA-617 Phase III Study Successfully: Significantly Extend Patients’ Life!-Novartis Zone-Biology Valley

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June 05, 2021/Bio Valley BIOON/ – Novartis recently announced the targeted radioligand therapy 177Lu-PSMA-617 for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) Phase 3 VISION The first results of the study. This is an international, prospective, randomized, open-label, multi-center study that evaluated the efficacy and safety of 177Lu-PSMA-617 combined with Best Standard of Care (SOC) and compared it with SOC alone. The results show that,Compared with SOC, 177Lu-PSMA-617 combined with SOC significantly prolonged overall survival (OS) and radiological progression-free survival (rPFS).
177Lu-PSMA-617 is a radioligand therapyThis type of therapy combines a targeted compound that binds to tumor-expressed markers and a radioisotope, which can cause DNA damage and inhibit tumor growth and replication. This treatment method can precisely target the delivery of radiation to tumor cells while limiting damage to surrounding normal tissues.
The prognosis of metastatic prostate cancer is very poor, and the chance of survival for 5 years is only 30%. The above-mentioned first phase 3 data from radioligand therapy for advanced prostate cancer confirmed the potential of 177Lu-PSMA-617 to improve clinical outcomes. Based on the results of this research, Novartis plans to submit a listing application for 177Lu-PSMA-617 in the United States and the European Union in the second half of 2021. The company also plans to launch two key early metastatic prostate cancer treatment studies in the second half of this year, with the goal of entering the early stages of the disease.

Prostate cancer (Image source: hopkinsmedicine.org)

The VISION study enrolled 831 patients with mCRPC who had previously received taxane and androgen receptor-directed therapy (ARDT) and had progressed and had a positive PSMA-PET scan. In the study, these patients were randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group (n=551) received 177Lu-PSMA-617 (a intravenous infusion of 7.4 GBq every 6 weeks, up to 6 cycles) and SOC treatment, and the control group (n=280) only received SOC treatment. The primary endpoints of the study are radiological progression-free survival (rPFS) and overall survival (OS).

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The results showed that the study reached two primary endpoints: Compared with SOC treatment, 177Lu-PSMA-617 combined with SOC treatment significantly prolonged OS and rPFS in PSMA-positive mCRPC patients. The specific efficacy data are: (1)In terms of OS, compared with the SOC group, the OS of the 177Lu-PSMA-617+SOC group was significantly improved (median OS: 15.3 months vs 11.3 months), and the difference in OS between the groups (4 months) was statistically significant ( Unilateral p<0.001), the risk of death is reduced by 38%(HR = 0.62 ; 95% CI: 0.52-0.74) ; (2)In terms of rPFS, compared with the SOC group, the rPFS of the 177Lu-PSMA-617+SOC group was significantly improved (median rPFS: 8.7 months vs 3.4 months), and the difference in OS between the groups (5.3 months) was statistically significant ( Unilateral p<0.001), radiological progression or risk of death reduced by 60%(HR = 0.40 ; 99.2% CI: 0.29-0.57)。

The study also reached key secondary endpoints: (1) The time to the first symptomatic skeletal event was significantly delayed. The median time to the first symptomatic skeletal event in the 177Lu-PSMA-617+SOC group was 11.5 months (95%). CI: 10.3, 13.2), while the SOC group was 6.8 months (95%CI: 5.2, 8.5) (HR=0.50; 95%CI: 0.40-0.62; bilateral p<0.0011. (2) Overall response rate (ORR) ) Has a significant improvement, and there are significant differences in ORR in patients with measurable or unmeasurable diseases at baseline examination (177Lu-PSMA-617+SOC group has a partial or complete remission rate of 29.8%, and SOC group has only a partial remission rate of 1.7 %; Bilateral p<0.001); (3) The disease control rate (DCR) has been significantly improved, 89.0% in the 177Lu-PSMA-617+SOC group and 66.7% in the SOC group (bilateral p<0.001).

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In terms of safety, the incidence of drug-related adverse events (TEAE) reported during treatment in the 177Lu-PSMA-617+SOC group was higher than that in the SOC group (85.3% vs 28.8%). Regarding the discontinuation rate related to TEAE, 11.9% of patients in the 177Lu-PSMA-617+SOC group discontinued 177Lu-PSMA-617, 8.5% of patients discontinued SOC, and 7.8% of patients in the SOC group discontinued treatment.

177Lu-PSMA-617 (Image source: embs.org)

Prostate cancer is a cancer that occurs in the prostate, which is a small walnut-shaped gland in the male pelvis. In castration-resistant prostate cancer (CRPC), despite the use of hormone therapy that lowers testosterone, the tumor still has signs of growth, such as elevated prostate-specific antigen (PSA) levels. In metastatic CRPC (mCRPC), the tumor spreads to other parts of the body, such as adjacent organs or bones, and still does not respond to hormone therapy. The 5-year survival rate of mCRPC patients is about 15%.
Although progress has been made in the treatment of prostate cancer, there is still a very high unmet medical demand for new targeted therapies for mCRPC patients.More than 80% of prostate cancer tumors highly express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), which makes it a promising diagnostic target (by positron emission tomography)[PET]Scan imaging) and the therapeutic target of radioligand therapy.
177Lu-PSMA-617 is a PSMA targeted radioligand therapy developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The drug is a precise cancer treatment that combines targeted compounds (ligands) and therapeutic radioisotopes (radioactive particles). After being injected into the blood, 177Lu-PSMA-617 binds to prostate cancer cells expressing PSMA (a transmembrane protein), so the tumor has a higher drug uptake rate than normal tissues. Once bound, the radiation (beta particles) from the radioisotope can damage tumor cells, destroy their ability to replicate and/or trigger cell death. The radiation of radioisotopes only works over a short distance to limit damage to surrounding cells. (Bioon.com)

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原文出处:Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study

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