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MEDSIR’s Experience at ASCO GU 2022: Update on our 2 GU trials

On February 17-19, the MEDSIR team attended the 2022 ASCO Genitourinary (GU) Cancers Symposium held in San Francisco, CA. It was a great opportunity to present our ongoing clinical trials and to meet our scientific collaborators, business partners, and friends, and catch up with the latest news and developments in the genitourinary cancer space. We were excited to present 2 of our sponsored studies this year!

On February 17th, Dr. Joaquin Mateo, from Vall d’Hebron Institute of Oncology (VHIO) and Vall d’Hebron University Hospital (VHIR), presented the study design of ZZFIRST trial. It is a multicenter, open-label, randomized, two-arm, phase II clinical trial, focused on exploring the benefits of PARP inhibition beyond patients with DNA damage repair genomic defects, and prolonging the clinical benefit from patients receiving enzalutamide. This proof-of-concept study is assessing the impact of androgen receptor (AR) inhibition in the regulation of homologous recombination and non-homologous end joining genes at the transcriptional level through the collection of sequential tumor samples. During different timepoints, blood samples for longitudinal circulating tumor cells and ctDNA will be collected for analysis. Additionally, to explore biomarkers of response and resistance to the study drugs, a subset of patients will have whole body diffusion weighted MRI at baseline and during treatment. As of January 2022, 52 patients have been enrolled and 49 are currently receiving treatment.

The combination of AR and PARP inhibition is showing potential in the late castration-resistant prostate cancer setting. The ZZFIRST trial is evaluating the antitumor activity of enzalutamide together with the PARPi talazoparib in the metastatic hormone-naive setting, aiming to study the mechanisms for this combinatory synergy by leveraging patient biopsies,” affirms Dr. Joaquin Mateo.

On February 19th, Dr. Xavier García del Muro, head of the Genitourinary Cancer Unit at Catalan Institute of Oncology (ICO), presented study design of the ongoing ORPHEUS study that evaluates the activity of immunotherapy in a series of patients with advanced penile squamous cell carcinoma (PSqCC). ORPHEUS is an international, multicenter, open-label, single-arm, phase II clinical trial and was opened to accrual in March 2020, and a total of 18 patients have already been recruited across 13 institutions in Spain and Italy. The primary objective of the study is to determine overall response rate of the anti–PD-1 antibody retifanlimab (INCMGA00012), with secondary objectives of assessing clinical benefit rate, duration of response, and progression-free survival among others. In addition, the trial has exploratory objectives of evaluating tumor and microenvironment-related factors associated with disease activity status and response to immunotherapy. The trial will also evaluate the impact of retifanlimab of HIV control in HIV-positive patients.

“PSqCC is a rare tumor with poor prognosis and limited therapeutic options. The current standard of care for advanced disease has been palliative platinum-based chemotherapy, with only marginal survival benefit. Immunotherapy could mean new way of treatment for these patients,” says Dr. Xavier García del Muro.

ASCO GU 2022 was a great, successful meeting and we can't wait till next year to see what new advances in the treatment of genitourinary cancers are presented. The posters are now available to download from our website and feel free to connect with us if you want more information on these or any of our other exciting trials at MEDSIR!



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