Breaking boundaries: Exploring extended pembrolizumab in first-line treatment of renal cell carcinoma with axitinib-pembrolizumab combination.

• DOI: 10.1200/jco.2024.42.4_suppl.436
• Publication Date: 2024-01-29T21:06:41Z
• Authors: Can Aydogdu; Pia Paffenholz; Ramona Stelmach; Katrin Schlack; Florian Roghmann; Analena Handke; Subhajit Mandal; Marco Schnabel; Axel Merseburger; Philipp Ivanyi; Stefanie Zschaebitz; Christopher Darr; Viktor Grünwald; Christian G. Stief; Jozefina Casuscelli
• Keywords: Axitinib; Renal carcinoma

436 Background: The standard first-line treatment for metastatic renal cancer (mRCC) combines immune checkpoint- (ICI) and tyrosine kinase inhibitors (TKI). While TKI therapy continues until disease progression, ICI is typically stopped after 24 months or 35 cycles, aligning with approval study criteria. However, in real-world practice, the decision to discontinue upon achieving a positive response can be distressing both patients healthcare providers; thus ICIs are not stopped. We conducted an initial analysis of prolonged pembrolizumab (Pem) use axitinib-pembrolizumab (Axi-Pem) combination evaluate its effects toxicity. Methods: retrospectively analyzed data from mRCC treated Axi-Pem 10 German tertiary care centers between 2019 2023. After completing cycles Pem, were offered continued if was assessed. calculated objective rate (ORR) progression-free survival (PFS) start achievement 36 months. Adverse events (irAEs) reported following CTCAE 5.0 Results: Out 72 patients, 27 met strict eligibility criteria Keynote-426 (NCT02853331), at continuous Pem therapy. Patients had median age 65.7 years (range: 34-84), IMDC risk favorable/intermediate/poor 22.2%/55.5%/18.5%. Median follow-up 33.2 25.3-48.4). At 36-mos landmark, PFS reached (PFS 64.7%), ORR 63.6%, complete response, partial stable observed 9.1%(1)/54.5%(6)/9.1%(1) cases, respectively. Permanent discontinuation occurred due progressive two cases one case. Another case led immune-related Conclusions: In our selected patient cohort seeking therapy, responders who received beyond achieve sustained efficacy treatment. Furthermore, incidence irAEs does increase exposure Additional results 36-month landmark urgently needed further support clinical necessity feasibility ongoing light impact on overall financial burden care.