Judd Moul, MD, Reviews Studies From 2021 ASCO Showing Systemic Therapy Advancements in Prostate Cancer

During the 2021 American Society of Clinical Oncology Annual Meeting (2021 ASCO), updates in the treatment of castration-resistant prostate cancer (CRPC) were at the force of this data presented in the genitourinary space. Extended survival results from the phase ARAMIS trial (NCT02200614) were reported in patients with nonmetastatic CRPC using darolutamide (Nubequa) or placebo with androgen deprivation therapy. Another phase 3 trial, VISION (NCT03511664) was designed to evaluate 177Lu-PSMA-617 versus standard-of-care therapy in men with prostate-specific membrane antigen (PSMA)–positive metastatic CRPC.

Judd Moul, MD

Both trials demonstrated benefit of the experimental therapy in their respective patient cohorts, helping prolong overall survival versus standard-of-care regimens.

In an interview with CancerNetwork®, Judd Moul, MD, discussed these findings from the meeting and how they apply to everyday practice. He also commented on the lack of screenings for cancer during the pandemic and how this deficit caused many patients to receive their cancer diagnosis at later stages of the disease.

Moul, a urologic oncologist and James H. Semans, MD, Distinguished Professor Of Urologic Surgery in the School of Medicine of Duke University, discusses his interpretation of the data from 2021 ASCO.

CancerNetwork®: How do extended follow-up data from the ARAMIS trial further inform clinicians regarding the use of darolutamide in patients with nonmetastatic CRPC?

Moul: [This study] helps clarify the different options that we have for nonmetastatic castrate-resistant prostate cancer. For a bit of a historical perspective, prior to 2018, we really didn’t have any FDA-approved options to treat men with nonmetastatic castrate-resistant prostate cancer. Then between 2018 and 2019, we had 3 FDA-approved oral agents, all 3 of which are second-generation nonsteroidal oral antiandrogens, and they are apalutamide (Erleada), enzalutamide (Xtandi), and darolutamide. The ARAMIS trial that was reported at this year’s ASCO [Annual Meeting] is reporting on longer-term follow up of darolutamide. The key message is that they’ve proven the long-term safety of that oral agent. And since it has a slightly different mechanism of action and does not cross the blood-brain barrier as much as the other 2 agents, [investigators have] been able to show that the tolerability and safety is very good in the long term follow up.¹

Based on the results of the VISION trial, where do you see ¹⁷⁷Lu-PSMA-617 fitting into the treatment landscape of metastatic CRPC?

Moul: [This study was created for] men with metastatic castrate-resistant prostate cancer and ushered in a brand new therapeutic approach to treating [this disease]. From a historical perspective, we’ve had an amazing number of new treatments approved in the last decade, and this just adds to our toolbox of options. This therapy involves a very targeted treatment against prostate-specific membrane antigen, which is located on the surface of advanced prostate cancer cells. The targeted agent goes in and can kill prostate cancer cells in any location in the body. The clinical trial showed that the treatment was effective; it improves survival and disease-free survival in these men. Many of these men were heavily pretreated and had advanced disease. This is a brand-new approach to advanced prostate cancer and is potentially going to usher in a whole new age of therapeutics in men with advanced prostate cancer to treat both bony lesions as well as soft tissue metastasis.²

Is there anything else you would like to discuss?

Moul: With COVID-19, we’ve seen an uptick in the patients who have advanced prostate cancer because of the delay and lack of screening. These new therapeutic options are needed right now because we’re seeing worse disease as we continue through the pandemic.

References

1. Fizazi K, Shore N, Smith M, et al. Darolutamide (DARO) tolerability from extended follow up and treatment response in the phase 3 ARAMIS trial. J Clin Oncol. 2021;39(suppl 15): 5079. doi: 10.1200/JCO.2021.39.15_suppl.5079.

2. Morris M, De Bono J, Chi K, et al. Phase III study of lutetium-177-PSMS-617 in patients with metastatic castration-resistant prostate cancer (VISION). J Clin Oncol. 2021;39(supply 15):LBA4. doi: 10.1200/JCO.2021.39.15_suppl.LBA4.