Results of a phase II study of atezolizumab and bevacizumab in non-clear cell renal cell carcinoma (nccRCC) and clear cell renal cell carcinoma with sarcomatoid differentiation (sccRCC).

Authors

null

Rana R. McKay

Dana-Farber Cancer Institute, Boston, MA

Rana R. McKay , Bradley Alexander McGregor , Kathryn Gray , John A. Steinharter , Meghara K. Walsh , David A. Braun , Abdallah Flaifel , Eliezer VanAllen , Xiao X. Wei , Sabina Signoretti , Lauren Christine Harshman , Ulka N. Vaishampayan , Toni K. Choueiri

Organizations

Dana-Farber Cancer Institute, Boston, MA, Dana Farber Cancer Institute, Boston, MA, Dana-Farber Cancer Institute/ Partners CancerCare, Boston, MA, Brigham and Women's Hospital, Boston, MA, Stanford University School of Medicine, Stanford, CA, Karmanos Cancer Institute, Detroit, MI

Research Funding

Pharmaceutical/Biotech Company

Background: NccRCC and sccRCC have historically been underrepresented in clinical trials. Even with targeted therapy, most patients have inferior survival compared to clear cell renal cell carcinoma. The combination of atezolizumab and bevacizumab has demonstrated safety and efficacy in ccRCC. In this multicenter, phase II, open-label, single arm trial we evaluate the efficacy of atezolizumab and bevacizumab in patients with nccRCC and sccRCC with >20% sarcomatoid differentiation. Methods: Eligible patients had an ECOG performance status of 0-2 and may have received prior therapy. Prior PD-1/PD-L1 therapy was not allowed. Patients underwent a mandatory baseline biopsy and subsequently received atezolizumab 120 mg and bevacizumab 15 mg/kg intravenously every 3 weeks. Patients remained on therapy until radiographic progression, unacceptable adverse events, or withdrawal. The primary end point was overall response rate (ORR) as determined by RECIST version 1.1. Results: 65 patients were enrolled of whom 52 had ≥1 response assessment and were included in this analysis. 36 patients had nccRCC (papillary n=14, chromophobe n=8, unclassified RCC n=3, collecting duct n=3, translocation n=3, other n=5), and 16 patients had sccRCC. 17 patients received prior systemic therapy, 16 of whom had nccRCC. The ORR was 31% in the overall cohort (Table 1). 10 patients (19%) developed grade 3 treatment-related adverse events (AEs), half of which were immune-related. There were no grade 4-5 AEs. Conclusions: In this study, we show that therapy with atezolizumab and bevacizumab was safe and demonstrated anti-tumor activity in nccRCC and sccRCC. Further analyses will report ORR by histologic subtype and PD-L1 expression status. Analysis of tissue and blood-based biomarkers of response are ongoing. Clinical trial information: NCT02724878

Total
N=52
Histology
Prior Systemic Therapy
sccRCC
N=16
nccRCC
N=36
No
N=35
Yes
N=17
ORRN (%)16 (31)7 (44)9 (25)8 (23)8 (47)
Stable DiseaseN (%)23 (44)5 (31)18 (50)18 (51)5 (29)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2019 Genitourinary Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Abstract Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Clinical Trial Registration Number

NCT02724878

Citation

J Clin Oncol 37, 2019 (suppl 7S; abstr 548)

DOI

10.1200/JCO.2019.37.7_suppl.548

Abstract #

548

Abstract Disclosures