Real‐World Outcomes and Prognostic Factors of Immune Checkpoint Inhibitor Rechallenge for Metastatic Renal Cell Carcinoma: A Multicenter Study
Shunya Matsumoto, Hajime Tanaka, Yuto Matsushita, Takahiro Kojima, Toshifumi Kurahashi, Yukari Bando, Takahiro Kimura, Naotaka Nishiyama, Shimpei Yamashita, Hisanori Taniguchi, Shunsuke Goto, Hironori Fukuda, Yoshihide Kawasaki, Hiroshi Kitamura, Hideaki Miyake, Yasuhisa Fujii,ABSTRACT
Objectives
Combination therapies incorporating immune checkpoint inhibitors (ICIs) are widely used as first‐line treatment for metastatic renal cell carcinoma (mRCC). However, the optimal sequence of subsequent therapies remains unclear. In this study, we investigated the real‐world outcomes of nivolumab rechallenge after first‐line ICI‐based combination therapy.
Methods
Twenty‐eight consecutive patients with mRCC who received nivolumab monotherapy as third‐ or later‐line treatment after first‐line ICI‐based combination therapy were identified from a multicenter database. The best overall response (BOR), progression‐free survival (PFS), overall survival (OS), immune‐related adverse events (irAEs), and prognostic factors associated with PFS were retrospectively analyzed.
Results
The median age was 68 years. Twenty‐two patients (78.6%) had clear cell RCC. Nivolumab was administered as third‐, fourth‐, and fifth‐line therapy in 19 (67.9%), 7 (25.0%), and 2 (7.1%) patients, respectively. The median follow‐up period was 6.4 months. The BORs were complete response, partial response, stable disease, and progressive disease in 0, 2 (7.1%), 7 (25.0%), and 19 (67.9%) patients, respectively. The median PFS and OS were 2.2 and 8.8 months, respectively. irAEs occurred in 7 patients (25.0%), including 5 patients (17.9%) with grade 3 irAEs. No grade 4 or higher events were observed. In multivariable analysis, good performance status and a shorter duration of first‐line ICI‐based combination therapy were associated with improved PFS.
Conclusions
Nivolumab rechallenge demonstrated modest efficacy in patients with mRCC after first‐line ICI‐based combination therapy, although a limited subset of patients may derive clinical benefit from this approach. irAEs during nivolumab rechallenge were generally manageable.