Updated efficacy, safety, and correlative analysis of a phase II trial in metastatic renal cell carcinoma with coordinated pembrolizumab and high dose IL-2.

• DOI: 10.1200/jco.2025.43.5_suppl.554
• Publication Date: 2025-02-18T14:35:11Z
• Authors: Jeffrey S Johnson; Mayer N Fishman; Michael J Schell; Xiaoqing Yu; Xuefeng Wang; Gabriel Roman Souza; Justin Miller; Sarah Raymond Miz...; Keerthi Gullapalli; Adnan Nazir Fazili; Christopher Guske; Gowtam Mannam; Ghazal Jameel; Ling Cen; Jiqiang Yao; Junmin Whiting; Jennifer Swank; Jingsong Zhang; Philippe E. Spiess; Jad Chahoud

554 Background: The CM 214 trial with Nivolumab-ipilimumab recently presented its long term follow up results regards to efficacy and safety. In this abstract, we similarly present extended 6 year of efficacy, safety, correlative data from the phase 2 clinical combining IL-2 short course pembrolizumab (pembro) for patients (pts) metastatic renal cell carcinoma (mRCC). Methods: This study included pts untreated clear mRCC ECOG 0-1 status. Pts were treated a maximum four 9-week blocks pembro/IL-2. Pembro was dosed every 3 weeks throughout all without subsequent maintenance dosing. High dose administered only during 3. At fixed time points, proteomic via Olink gene expression Nanostring obtained analysis. Kaplan-Meier method utilized determine updated overall survival (OS), progression-free (PFS), treatment-free (TFS). TFS defined as completion pembro/IL-2 initiation next therapy, date last if no line or death. used subdivide into extreme responders ( > 5 years further treatment), non-responders < months until therapy), others. Proteomics in responders, non-responders, others compared Wilcoxon rank sum test logarithmic fold change expression. Results: 27 enrolled 26 receiving treatment. number IMDC risk favorable, intermediate, poor 6, 19, 1, respectively. median on-study known alive expired 73 (range: 13-86). OS probabilities 1-, 3-, 5-year intervals 100% (95% confidence interval [CI]: 100-100%), 76.9% (CI: 55.7-88.9%), 73.1% 51.7-86.2%) PFS at 61.5% 40.3-77.1%), 42.3% 23.5-60.0%), 23.5-60.0%) (23.5-60.0%), (23.5-60.0%) Of 11 durable disease control not requiring any systemic none had persistent adverse events grade higher level. comparison IL-8 found have 1.43 log p-value 0.019 detected by assay. Additionally, ADA GZMH showed -0.82 -1.57 assay p-values 0.002 0.039 Further will be meeting. Conclusions: Short pembro combination high allows immune response. up, 40% toxicity need therapy. Moreover, highlight select biomarkers that could associated long-term Clinical information: NCT02964078 .