Home > Oncology > ASCO 2024 > Genitourinary Cancer > Highest efficacy of nivolumab/chemotherapy in lymph-node-only metastatic urothelial carcinoma

Highest efficacy of nivolumab/chemotherapy in lymph-node-only metastatic urothelial carcinoma

Presented by
Prof. Matthew Galsky, Tisch Cancer Institute, NY, USA
Conference
ASCO 2024
Trial
Phase 3, CheckMate 901
Doi
https://doi.org/10.55788/2c350e22
Patients with lymph-node-only metastatic urothelial carcinoma (mUC) benefit most from nivolumab plus gemcitabine/cisplatin, an exploratory analysis of the phase 3 CheckMate 901 trial demonstrated.

Results of the phase 3 CheckMate 901 trial (NCT03036098) demonstrated that nivolumab plus gemcitabine/cisplatin was beneficial over gemcitabine/cisplatin alone in patients with previously untreated unresectable or mUC [1]. Lymph-node-only metastatic disease is a favourable prognostic factor in mUC. Therefore, a post-hoc analysis of CheckMate 901 was conducted to characterise outcomes in this subpopulation. Prof. Matthew Galsky (Tisch Cancer Institute, NY, USA) presented the results [2].

CheckMate 901 enrolled 606 participants, of whom 110 had lymph-node-only metastatic disease. The lymph-node-only group showed improved objective response rates (ORR) compared with all randomised participants, regardless of receiving nivolumab/chemotherapy or chemotherapy alone (see Figure).

Figure: Objective response rate in CheckMate 901 [2]



The median progression-free survival (PFS) in lymph-node-only participants was 30.5 months with nivolumab/chemotherapy and 8.8 months with chemotherapy alone (HR 0.38). In all randomised participants, the median PFS was 7.9 versus 7.6 months (HR 0.72). The median overall survival (OS) in lymph-node-only participants was 46.3 months with nivolumab/chemotherapy and 24.9 months with chemotherapy alone (HR 0.58). In all randomised participants, the median OS was 21.7 versus 18.9 months (HR 0.78).

In the nivolumab/chemotherapy arm, 41% of lymph-node-only participants with complete response (CR) experienced a disease-free interval and ongoing response without subsequent therapy after the study treatment ended at 24 months.

“In patients with lymph-node-only mUC, the combination of nivolumab plus gemcitabine/cisplatin induced a durable disease control and clinically meaningful improvements in PFS and OS over gemcitabine/cisplatin alone,” concluded Prof. Galsky.

  1. Van der Heijden MS, et al. N Engl J Med 2023;389:1778-1789.
  2. Galsky MD, et al. Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node–only metastatic urothelial carcinoma from the CheckMate 901 trial. Abstract 4509, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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