Impact of Immunotherapy Prescribing Restrictions on Time to Systemic Therapy and Outcomes in Metastatic Clear Cell Renal Carcinoma in Australia.

Authors

Evon Jude, Elizabeth Liow, Jeremy Shapiro, Arun A Azad, Megan Crumbaker, Ganes Pranavan, Christopher Hocking, Felicia Roncolato, Annabel Smith, Shirley Wong, Angelyn Anton, Julie Johns, Peter Gibbs, Ben Tran, Andrew Weickhardt

Published in

Asia-Pacific journal of clinical oncology. Aug 21, 2026. Epub Aug 21, 2026.

Abstract

Combination immunotherapy (Ipi/Nivo) was approved in Australia in 2019 for metastatic clear cell kidney cancer (mccRCC) patients with International Metastatic Database Consortium (IMDC) intermediate and poor-risk. Although selected patients can safely delay treatment due to indolent disease, delaying treatment beyond 1 year in patients without other IMDC risk factors classifies them as favorable risk and prevents access to Ipi/Nivo. This study investigated the impact of Ipi/Nivo approval on timing of treatment initiation and outcomes.
Multicenter retrospective cohort study analyzing real-world data from the Kidney canceR Australian registry and Biobank (KRAB) was used to identify patients > 18 years with mccRCC who received systemic therapy. Patient demographics, time to systemic therapy (TTST) from diagnosis of metastatic disease, and outcomes were compared for patients diagnosed with metastatic disease before and from January 2019.
A total of 494 patients met study criteria. The 256 patients diagnosed from 2019 had a significant decrease in both mean TTST (3.9 months from 15.3 months) and proportion with TTST ≥ 1 year (8.2% from 27.7%). More patients met criteria for intermediate and poor-risk disease from 2019 (61% from 49%). Of the 242 patients with de novo metastatic disease, the proportion with TTST ≥ 1 year decreased from 2019 (5.2% from 16.7%). Despite this, there was no significant difference in overall survival before and from 2019.
Prescribing restrictions for Ipi/Nivo in Australia were associated with a substantial change in prescribing practice for patients with mccRCC, without any change in survival outcomes.

PMID:
42629959
Bibliographic data and abstract were imported from PubMed on 22 Aug 2026.

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