Guru Sonpavde: CheckMate 901 Trial Data on First-Line Nivolumab in LN-Only Metastatic Urothelial Carcinoma
Guru Sonpavde, GU Oncology and Phase I Clinical Trials Director, Chair of Bladder Cancer Research at AdventHealth Central Florida, shared a post on LinkedIn about a paper he co-authored with colleagues published in European Urology.
“Analysis of the CheckMate 901 Phase III trial published in European Urology – first-line Nivolumab (NIVO) plus gemcitabine-cisplatin (GC) provided considerable overall survival (OS) and progression-free survival (PFS) benefits versus GC in patients with metastatic urothelialcarcinoma (mUC) and lymph node (LN)-only disease (~15-20% of first-line mUC population).
The HR for OS was 0.58 with median OS 46.3 mo vs. 24.9 mo, and the HR for PFS was 0.38 with median PFS 30.5 vs. 8.84 mo for GC-NIVO vs. GC in this subgroup. The objective response rate (ORR) in this subgroup 81% vs. 64%, and CR rate was 63% vs 34% for GC-NIVO vs. GC. GC was given for a finite duration up to 6 cycles, and NIVO continuing for ≤24 mo; 41% of complete responders in the LN-only group on GC-NIVO maintained CR off all the treatment at the last follow-up, versus 16% in the GC arm.
Message: GC-NIVO appears to be an excellent first-line option in those with cisplatin-eligible mUC and LN-only metastasis (GC-NIVO is US FDA approved for patients with mUC as first-line therapy)- honored to participate from AdventHealth Central Florida Cancer Institute and Dana-Farber Cancer Institute in clinical trial and study sponsored by Bristol Myers Squibb.”
Guru Sonpavde discussed the newly published CheckMate 901 Phase III trial results, demonstrating that Nivolumab combined with gemcitabine and cisplatin offers substantial survival and response benefits in patients with lymph node-only metastatic urothelial carcinoma.
Title: Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial
Authors: Matthew D. Galsky, Michiel S. van der Heijden, Thomas Powles, Melanie Claps, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Yüksel Ürün, Dingwei Ye, Begoña P. Valderrama, Yoshihiko Tomita, Ruiyun Jiang, Jeiry Filian, Lily Wang, Maximiliano van Kooten Losio, Guru Sonpavde.
Read the Full Article in European Urology.
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