Dana-Farber Cancer Institute researchers will present important research studies during the 2025 ASCO Genitourinary (GU) Cancers Symposium, on February 13-15, 2025, in San Francisco, Calif. The ASCO GU Symposium is the leading specialized research and education meeting for global GU cancer care.
The Dana-Farber-led research exemplifies innovative and multidisciplinary expertise in prostate, kidney, and bladder cancers, and includes studies examining novel treatments and predictive biomarkers.
Notable oral presentations of studies presented or led by Dana-Farber experts include:
Toni K. Choueiri, MD, Director, Lank Center for Genitourinary Oncology at Dana-Farber
Novel HIF-2alpha inhibitor well-tolerated and shows promising clinical activity in phase 1 study
A novel HIF-2alpha inhibitor called casdatifan was well-tolerated and showed promising early clinical activity in heavily pretreated patients with clear cell renal cell carcinoma (ccRCC) in a phase 1 trial called ARC-20. Researchers led by Toni K. Choueiri, MD, initiated a phase 1 open-label study to evaluate casdatifan in adult patients with ccRCC who had previously been treated with anti-PD-(L)1 checkpoint inhibitors and anti-angiogenic therapies but not anti-HIF-2alpha inhibitors. HIF-2alpha is known to accumulate in ccRCC and to upregulate pathways that drive cancer growth. Casdatifan is an oral medication that blocks the creation of HIF-2alpha by inhibiting transcription of genes it depends on. The team will present safety, efficacy, and subgroup analysis across multiple doses.
This study was funded by Arcus Biosciences.
Title: Casdatifan Monotherapy in Patients with Previously Treated Clear Cell Renal Cell Carcinoma: Safety, efficacy and subgroup analysis across multiple doses from ARC-20, a Phase 1 Open-Label Study
Abstract: 441
Presenter: Toni K. Choueiri, MD
Session: Rapid Oral Abstract Session C: Renal Cell Cancer and Penile Cancer
Watch Video: ASCOGU25: Toni Choueiri MD | Dana-Farber Cancer Institute
Wenxin (Vincent) Xu, MD, Medical oncologist, Lank Center for Genitourinary Oncology at Dana-Farber
Study identifies potential biomarker for monitoring patients with advanced kidney cancer after immunotherapy
A KIM-1 blood test can identify earlier which patients benefit from treatment with nivolumab and ipilimumab in advanced renal cell carcinoma, according to a post-hoc analysis of data from the CheckMate 214 trial. The researchers found that higher KIM-1 at baseline was associated with worse clinical outcomes, and that a reduction in KIM-1 three weeks after a single cycle of the combination therapy was associated with long-term efficacy. The findings support previous research that has shown that high levels of circulating KIM-1 are associated with worse outcomes, and reductions in KIM-1 levels are associated with benefits from immunotherapy. Based on these findings, KIM-1 could be used as a minimally invasive biomarker for monitoring patients after immunotherapy for advanced renal cell carcinoma.
This study was funded by the National Institutes of Health.
Title: Evaluation of circulating kidney injury marker-1 (KIM-1) as a prognostic and predictive biomarker in advanced renal cell carcinoma (aRCC): Post-hoc analysis of CheckMate 214
Abstract: 437
Presenter: Wenxin (Vincent) Xu, MD
Session: Biomarkers and Adjuvant Therapy for Renal Cell Carcinoma: Current State and Future Directions
Watch Video: ASCOGU25: Dr. Vincent Xu, MD | Dana-Farber Cancer Institute
Final follow-up from pivotal CheckMate9ER trial that led to FDA approval of first-line combination therapy for advanced kidney cancer
An immunotherapy agent (nivolumab) combined with a tyrosine kinase inhibitor drug (cabozantinib) significantly improved progression-free survival and reduced the risk of death compared to a single agent treatment with sunitinib in advanced kidney cancer patients, according to final follow-up results of phase 3 CheckMate 9ER clinical trial. In 2021, results from the trial led to the approval by the U.S. Food and Drug Administration (FDA) of the combination of nivolumab and cabozantinib as a first-line treatment for patients with advanced renal cell carcinoma (RCC). CheckMate 9ER evaluated the combination compared to sunitinib. Patients receiving the combination had a higher response rate and superior quality of life. Over the long term, patients benefitted from the combination over sunitinib with no new safety signals after a median of more than 5 and a half years of follow up.
This study was supported in part by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen, and Takeda Pharmaceutical Company Limited. Choueiri is supported in part by the Jerome and Nancy Kohlberg Chair at Harvard Medical School.
Title: Nivolumab plus cabozantinib (N+C) versus sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Final follow-up results from the CheckMate 9ER trial
Abstract: 439
Senior Investigator: Toni K. Choueiri, MD
Session: Oral Abstract Session C: Renal Cell Cancer and Testicular Cancer
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The full list of Dana-Farber-led presentations at ASCO GU is available here: ASCO GU 2025 Dana-Farber Presentations