The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA between February 13–15, 2025 was host to a renal cell, adrenal, penile, testicular, and urethral cancers poster session. Dr. Robert Uzzo presented the results of a real-world analysis of pembrolizumab utilization and characteristics of patients being prescribed treatment in early stage RCC.
Adjuvant pembrolizumab was approved in the U.S. on November 17, 2021, for patients with RCC with intermediate-high (T2N0M0-G4, T3N0M0, any grade) or high-risk (T4, any grade; N+, any T, any grade; and M1 NED patients) of recurrence following nephrectomy.1 This study evaluated the adoption of adjuvant pembrolizumab in routine practice and the demographic and clinical characteristics of post-nephrectomy RCC patients who received this therapy.
The US Oncology Network, one of the largest physician networks in the US, includes >600 sites and >2,700 care providers, treating ~ 15% of U.S. cancer patients. Electronic health record data from IKnowMed were manually abstracted for patients receiving care in The US Oncology Network clinics. The study eligibility criteria were as follows:
- Inclusion:
- Adult patients with non-metastatic, localized RCC who underwent nephrectomy between November 17, 2021, and December 31, 2022, within the U.S. Oncology Network
- Exclusion:
- Patients participating in a clinical trial or treated for another primary cancer during the study period
This retrospective study conducted descriptive analyses of demographic, clinical, and treatment characteristics for patients receiving adjuvant pembrolizumab monotherapy and those who did not. Real-world time on treatment was defined as the interval between treatment initiation and treatment discontinuation. Factors associated with pembrolizumab use were evaluated using multivariable logistic regression analysis.
Overall, 178 patients were included; baseline patient demographics are presented in the table below. The mean age was 62 years, and 66.3% of patients were men. Of patients with documented race/ethnicity (82.6%), 63% were White and 7.3% were Black. The majority were diagnosed at Stage III (79%). Clear cell renal cell carcinoma (ccRCC) was the predominant histological subtype (83%).
The median time from nephrectomy to the first oncology visit was 31 days. The median follow-up was 7.9 months. Of patients with documented disease risk (84.3%), 48.3% were intermediate-high risk and 57.3% were high-risk.
The majority of patients received adjuvant pembrolizumab monotherapy (66.3%). Among those who received adjuvant pembrolizumab, the median follow-up was 8.3 months.
The median real-world time on treatment was 11.5 months in the overall and high-risk cohorts and 10.6 months in the intermediate-high-risk cohort. Notably, the recommended duration of treatment for adjuvant pembrolizumab is 12 months.
On multivariable analysis evaluating predictors of receipt of adjuvant pembrolizumab, patients with non-ccRCC histology had 93% lower odds (OR: 0.07, p<0.001) and those with a 1st oncologist visit ≥2 months post-nephrectomy had 61% lower odds (OR: 0.39, p=0.035) of receiving adjuvant pembrolizumab treatment.
Dr. Uzzo concluded as follows:
- Adjuvant pembrolizumab demonstrated notable uptake among post-nephrectomy RCC patients in a community setting
- The real-world time on treatment was similar as observed in the Keynote 564 trial
- RCC histology and timing of oncologist visits post-surgery significantly influenced treatment adoption
- Future research should examine referral patterns, treatment barrier, and strategies to enhance adoption, as well as explore long-term outcomes and real-world effectiveness
Presented by: Robert G. Uzzo, MD, MBA, FACS, President and Chief Executive Officer, Fox Chase Cancer Center, Temple University Health, Philadelphia, PA
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.
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