A UK real-world observational study of avelumab + axitinib (A + Ax) in advanced renal cell carcinoma (aRCC): 24-month interim results.

Authors

null

Paul D. Nathan

Mount Vernon Cancer Center, Northwood, United Kingdom

Paul D. Nathan , Natalie Charnley , Ricky Frazer , John McGrane , Iqtedar A Muazzam , Sarah Rudman , Anand Sharma , Robert Stevenson , Joseph David Hickey , Arpan Tahim , Aimi Rose Ritchie

Organizations

Mount Vernon Cancer Center, Northwood, United Kingdom, Lancashire Teaching Hospitals, Preston, United Kingdom, Velindre Cancer Centre, Cardiff, Wales, United Kingdom, Royal Cornwall Hospital NHS Trust, Cornwall, United Kingdom, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, Guy's and St Thomas NHS Foundation Trust, London, United Kingdom, Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust, Middlesex, United Kingdom, Queen Elizabeth Hospital, Birmingham, United Kingdom, Real-World Evidence, OPEN Health, Marlow, United Kingdom, Pfizer Ltd, Tadworth, Surrey, United Kingdom, Pfizer Ltd, Tadworth, United Kingdom

Research Funding

Pharmaceutical/Biotech Company
This study was sponsored by Pfizer as part of an alliance between Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945)

Background: Combination therapy with A + Ax in patients with previously untreated aRCC has shown superior progression-free survival (PFS) and objective response rate (ORR) vs sunitinib across all International Metastatic RCC Database Consortium (IMDC) risk groups. This study reports 24-month real-world outcomes in patients with aRCC receiving A + Ax in the UK. Methods: Patients were recruited from 9 UK sites. Inclusion criteria were diagnosis of aRCC, initiation of A + Ax on or after August 1, 2019, via the Early Access to Medicines Scheme, and age ≥18 years. The primary endpoints were overall survival (OS), PFS, ORR, and best response at 24 months post-A + Ax initiation. Data were analyzed descriptively. Total recruitment was 130 patients. Follow-up will continue until July 2023. Results: This analysis includes 78 patients with a minimum follow-up of 24 months. Median age at baseline was 66.6 years (range, 39.8-84.1 years); 76% (n=59) of patients were male, 63% (n=49) were White, 5% (n=4) were Asian/Asian British, and ethnicity was not recorded in 32% (n=25); 91% (n=71) had an Eastern Cooperative Oncology Group score of 0 or 1. IMDC risk status was favorable in 42% (n=33) of patients, intermediate in 41% (n=32), and poor in 17% (n=13). Median time between aRCC diagnosis and A + Ax initiation was 2.5 months (range, 0.03-90.4 months; n=77). Clear cell histology was the most prevalent (81% [n=63]); 68% (n=53) of patients had undergone nephrectomy, and 74% (n=58) had 1 or 2 metastatic sites at the index date. The OS rate at 24 months was 60% (95% CI, 49.4%-71.1%). The OS rates by IMDC risk status were: favorable, 76% (95% CI, 61.1%-90.4%); intermediate, 63% (95% CI, 45.7%-79.3%); and poor, 15% (95% CI, 0%-35.0%). The PFS rate at 24 months was 31% (95% CI, 20.5%-41.0%); median PFS was 9.1 months (95% CI, 7.9-13.4 months). ORR (n=76) at 24 months was 59% (95% CI, 48.2%-70.3%), with 4% (n=3) achieving complete response (CR) and 55% (n=42) partial response (PR). Best responses observed within 24 months were CR in 4% (n=3), PR in 54% (n=42), stable disease in 29% (n=23), and progressive disease in 10% (n=8) (2 not recorded). Median duration of response was 11.9 months (range, 0.4-23.7 months). Median time to discontinuation (TTD) of either A or Ax was 5.5 months (range, 0.5-20.5 months; n=50). Median TTD of A + Ax combined was 5.6 months (range, 0.8-20.5 months; n=43). Of 78 patients, 62 experienced an adverse event (AE) due to A + Ax treatment, 8 of whom had 14 serious AEs in total. The most common AEs were diarrhea (n=31), fatigue (n=22), and rash or oral mucositis (n=18 each); 3 patients discontinued Ax due to AEs including diarrhea (n=2), abnormal hepatic function (n=1), and abdominal pain (n=1). Conclusions: This UK-based real-world study of A + Ax treatment reports 24-month clinical outcomes in patients with aRCC. OS, PFS, ORR, and best response were in line with findings from prior clinical trials, with no new emerging AEs.

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 631)

DOI

10.1200/JCO.2023.41.6_suppl.631

Abstract #

631

Poster Bd #

F1

Abstract Disclosures