Real-world (RW) characteristics and outcomes in patients (pts) with muscle-invasive urothelial carcinoma (MIUC) treated with adjuvant nivolumab (NIVO) with or without neoadjuvant chemotherapy (NAC)

BackgroundClinical trials suggest that prior NAC treatment may improve adjuvant NIVO outcomes in pts with MIUC at high risk for recurrence after radical resection; investigation in RW pts could help inform treatment sequencing. We characterized RW pts with MIUC who received adjuvant NIVO stratified by whether they received prior NAC.MethodsIn this retrospective medical chart review of pts with stage II-IIIB MIUC who began adjuvant NIVO between 9/1/2021 and 11/25/2022, physicians from the Cardinal Health Oncology Provider Extended Network abstracted pt data from electronic records. Pt characteristics and survival point estimates per Kaplan–Meier analyses were summarized via descriptive statistics.Results253 pts with MIUC were treated with adjuvant NIVO; 141 (55.7%) received and 112 (44.3%) did not receive NAC. Median NAC duration was 2.8 mo; gemcitabine plus cisplatin (84.4%) was the most common regimen. Pts who received NAC were younger at diagnosis (mean, 64.0 vs 70.8 y) and more likely to have commercial insurance (40.4% vs 9.8%) vs pts who did not receive NAC. At adjuvant NIVO initiation, more pts who received NAC had stage IIIB disease (30.5% vs 17.9%), better functional status (ECOG PS 0 or 1, 97.2% vs 63.4%), and fewer comorbidities (mean NCI comorbidity index, 0.33 vs 0.71) vs pts who did not receive NAC. Majority of pts who did not receive NAC were cisplatin ineligible (78.6% vs 6.4%); the most common eligibility criterion was creatinine clearance (88.5%). Median follow-up from start of adjuvant NIVO was 13.3 mo in pts who received NAC and 12.3 mo in pts who did not receive NAC. Pts who received NAC had better 18-mo overall survival (90.1% vs 55.5%, P = 0.02) and 18-mo distant metastasis-free survival (86.6% vs 54.6%, P < 0.01) outcomes from the start of adjuvant NIVO.ConclusionsPts with MIUC who received NAC before adjuvant NIVO were overall younger, healthier, and more likely to have stage IIIB disease. RW outcomes of adjuvant NIVO were favorable overall, and NAC pts showed improved outcomes vs pts who did not receive NAC. Further research with extended follow-up and adjustment for baseline characteristics is needed to elucidate observed differences.Legal entity responsible for the studyBristol Myers Squibb.FundingBristol Myers Squibb.DisclosureW.S. John: Financial Interests, Institutional, Local PI: Bristol Myers Squibb, Sobi, Inc., Pfizer, AbbVie, Bayer, Janssen, Daiichi Sankyo Inc. S. Lucht: Financial Interests, Institutional, Full or part-time Employment: Cardinal Health; Non-Financial Interests, Personal, Other, Covered travel and accommodation expenses to lobby U.S. Congress on behalf of cancer research funding for the NIH in Spring 2023: American Association for Cancer Research; Non-Financial Interests, Member: American Association for Cancer Research. T. Miller: Financial Interests, Institutional, Full or part-time Employment, Former employee from 2021 to Nov 2023: Cardinal Health; Financial Interests, Institutional, Stocks/Shares: Flatiron Health. P. Pathak: Financial Interests, Personal, Other, Contractor: Cardinal Health. E. Bland: Financial Interests, Institutional, Full or part-time Employment: Cardinal Health. A.J. Klink: Financial Interests, Personal, Full or part-time Employment, Employee: Cardinal Health; Financial Interests, Personal, Stocks/Shares, Employee Stock LTI: Cardinal Health; Financial Interests, Institutional, Funding: Astellas, BMS, BI, Bayer, AbbVie, Alexion, Adaptimmune, Ascentage, AstraZeneca, Daiichi, Eisai, EmitBio, Fresenius Kabi, Genentech, Greenwich, GSK, Hookipa, Incyte, Janssen, Jazz, Kite, MorphoSys, Pfizer, Taiho, Teva. B.A. Feinberg: Financial Interests, Institutional, Full or part-time Employment: Cardinal Health. N. Singh: Financial Interests, Personal, Full or part-time Employment, employee: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, carry stocks: Bristol Myers Squibb; Non-Financial Interests, Institutional, Proprietary Information, RWE data: Bristol Myers Squibb. C. Alonso: Financial Interests, Personal, Full or part-time Employment, I am employed by Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. M. Patel: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. L.C. Rosenblatt: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. X. Yin: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. A. Chehrazi-Raffle: Financial Interests, Personal, Advisory Board: Exelixis, Inc, Aveo Inc., Pfizer Inc.; Financial Interests, Personal, Invited Speaker: Exelixis, Inc, OncLive/MJH Life Sciences, ASCO Direct. All other authors have declared no conflicts of interest.