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An Expert’s Guide to Key Studies at the 2022 ASCO Genitourinary Cancers Symposium

Toni K. Choueiri, MD

Associate Professor of Medicine
Harvard Medical School
Director, Kidney Cancer Center
Clinical Director, Lank Center for Genitourinary Oncology
Department of Medical Oncology
Dana-Farber Cancer Institute
Boston, Massachusetts

Toni K. Choueiri, MD, has disclosed that he has received paid and unpaid support either personal or institutional for research, advisory boards, consulting, and honoraria from Aravive, AstraZeneca, Aveo, Bayer, Bristol Myers-Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Infinity, Ipsen, IQVA, Janssen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, and Tempest and has ownership interest in NuscanDx, Osel, Pionyr, and Tempest.

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Daniel P. Petrylak, MD

Professor of Medicine (Medical Oncology) and of Urology
Director, Prostate and GU Medical Oncology
Co-Director, Cancer Signaling Network Program 
Yale Cancer Center
New Haven, Connecticut

Daniel P. Petrylak, MD, has disclosed that he has received consulting fees from Ada Cap (Advanced Accelerator Applications), Amgen, Astellas, AstraZeneca, Bayer, Bicycle Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis Oncology, Exelixis, Incyte, Janssen, Lilly, Mirati, Monopteros, Pfizer, Pharmacyclics, Regeneron, Roche, Seattle Genetics, and Urogen; has received funds for research support paid to his institution from Ada Cap (Advanced Accelerator Applications), Agensys, Astellas, AstraZeneca, Bayer, BioXcel, Bristol-Myers Squibb, Clovis Oncology, Eisai, Endocyte, Genentech, Innocrin, Lilly, MedImmune, Medivation, Merck, Mirati, Novartis, Pfizer, Progenics, Replimune, Roche, Sanofi, and Seattle Genetics; and has ownership interest in Bellicum and Tyme.

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Released: February 15, 2022

During the ASCO Genitourinary (GU) Cancers Symposium being held February 17-19, 2022, important results from many clinical trials in genitourinary malignancies will be reported. Here are the top studies to watch for, as chosen by our experts Toni K. Choueiri, MD, and Daniel P. Petrylak, MD. These and other clinically important data will be covered online as a part of CCO’s Independent Conference Coverage of ASCO GU 2022.

Bladder Cancer
Toni K. Choueiri, MD:
Experience with other tumors suggests that urothelial carcinomas (UC)—which are generally sensitive to platinum and can harbor alterations in DNA damage repair genes—would be susceptible to PARP inhibition. However, PARP inhibitor monotherapy exhibits minimal activity in unselected patients with UC. Clinical activity may improve if PARP inhibition is combined with immune checkpoint inhibition and/or if patients are better selected using biomarkers for DNA damage repair alterations.

The combination therapy approach is under investigation in the phase II BAYOU trial. Rosenberg and colleagues will present data from BAYOU on first-line treatment with durvalumab plus olaparib vs durvalumab plus placebo in platinum-ineligible patients with stage IV UC. We will also see results in a molecularly selected population when Crabb and colleagues present the final analysis of the rucaparib arm from the phase II ATLANTIS trial, which evaluated maintenance PARP inhibition after chemotherapy in biomarker-selected patients with metastatic UC.

Daniel P. Petrylak, MD:
Enfortumab vedotin and sacituzumab govitecan are antibody–drug conjugates that are FDA-approved agents for patients with advanced UC after previous therapy with a platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor. Enfortumab vedotin is also approved by the FDA for patients with advanced UC who are ineligible for cisplatin-containing chemotherapy and have received ≥1 previous lines of therapy.

Enfortumab vedotin, targeting Nectin-4, has demonstrated activity in patients with previously treated advanced UC—suggesting that patients may benefit from receiving this systemic therapy earlier in the disease course. At ASCO GU 2022, my colleagues and I will present noteworthy results on the clinical activity of neoadjuvant enfortumab vedotin in platinum-ineligible patients with muscle-invasive bladder cancer enrolled on cohort H of the ongoing EV-103 trial.

Sacituzumab govitecan, targeting Trop-2, may augment a patient’s antitumor immune response by binding to immune cell receptors to promote antibody-dependent cellular cytotoxicity as well as through depleting regulatory T-cells, upregulating MHC class I and PD-L1 expression, and potentially supplementing antitumor activity of anti–PD-1PD-/L1 antibodies. At ASCO GU 2022, data from cohort 3 of the TROPHY-U-01 study will be presented showing the efficacy and safety of sacituzumab govitecan in combination with pembrolizumab for metastatic UC with disease progression after platinum-based regimens.

Prostate Cancer
Daniel P. Petrylak, MD:
Saad and colleagues will present much-anticipated results of the phase III PROpel trial comparing the addition of olaparib vs placebo to abiraterone as first-line treatment of metastatic castration-resistant prostate cancer (CRPC). The abstract reports positive results in patients with or without homologous recombination repair gene mutations—potentially eliminating the need for genetic testing before initiating a PARP inhibitor in patients with CRPC.

In the hormone-sensitive setting, Smith and colleagues will present overall survival results from the phase III ARASENS trial, which is comparing the addition of darolutamide vs placebo to androgen-deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer. It would be advantageous to have this agent available in the hormone-sensitive setting because noncomparative data suggest that the androgen receptor antagonist darolutamide is better tolerated than enzalutamide or apalutamide in nonmetastatic CRPC.

Kidney and Adrenal Cancers
Toni K. Choueiri, MD:
There is an ongoing need for efficacious adjuvant therapy in the setting of locoregional clear-cell renal cell carcinoma, given that approximately one half of patients experience disease recurrence after nephrectomy. The first analysis of the ongoing phase III KEYNOTE-564 trial demonstrated that adjuvant pembrolizumab after nephrectomy significantly reduced the risk of disease recurrence or death at 24 months by 32% vs placebo in patients with clear-cell renal cell carcinoma and an intermediate to high risk of recurrence. At ASCO GU 2022, my colleagues and I will present a 30-month follow-up of KEYNOTE-564.

Finally, Berruti and colleagues will present data from the phase III Adjuvo trial on adjuvant treatment with mitotane in patients with adrenocortical carcinoma, a very rare genitourinary malignancy with a high risk of recurrence after surgery. Retrospective data suggest benefit with adjuvant mitotane, but this is the first prospective trial evaluating this approach in adrenocortical carcinoma.

Remember to Check the CCO Website After the 2022 ASCO GU Cancers Symposium!
These are just a few of the interesting and important abstracts selected by our expert faculty from the 2022 GU Cancers Symposium. A downloadable highlight slideset of these studies will be available on our website after the data are presented. Also, after the meeting, a comprehensive analysis by our expert faculty members will explore the clinical implications of the data in a CME-certified text-based module.

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