Reference Detail

Ref Type

Journal Article

PMID

(32975815)

Authors

Feldman DR, Ged Y, Lee CH, Knezevic A, Molina AM, Chen YB, Chaim J, Coskey DT, Murray S, Tickoo SK, Reuter VE, Patil S, Xiao H, Aghalar J, Apollo AJ, Carlo MI, Motzer RJ, Voss MH

Title

Everolimus plus bevacizumab is an effective first-line treatment for patients with advanced papillary variant renal cell carcinoma: Final results from a phase II trial.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Cancer			2020 Sep 25	5247-5255	Cancer

URL

Abstract Text

We previously reported on a phase 2 study of everolimus plus bevacizumab across various nonclear cell renal cell carcinoma (nccRCC) histologies and observed encouraging activity among patients with papillary RCC (pRCC) and unclassified RCC (uRCC) with a major papillary component. We subsequently expanded the study to enroll additional patients with pRCC variants.Everolimus plus bevacizumab was administered at standard doses until disease progression or intolerance to therapy. The primary endpoint was the 6-month progression-free survival (PFS) rate; secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Correlative analyses included next-generation sequencing (NGS) from tumor and germline across >341 genes of interest.In addition to 19 patients with pRCC variants in the original cohort, 20 patients with similar features were enrolled on the expansion cohort (uRCC with papillary features [n = 24], pRCC [n = 14], and translocation-associated RCC with papillary features [n = 1]). Among 37 evaluable patients, the 6-month PFS rate was 78%, the median PFS was 13.7 months (95% CI, 10.8-16.4 months), and the ORR was 35%. With a median follow-up of 17.6 months, the median OS was 33.9 months (95% CI, 23.3-71.9). Tolerance was consistent with prior reports for everolimus plus bevacizumab. NGS results (n = 33) identified responses in patients with a wide spectrum of genomic alterations, including ARID1A, FH, and MET mutations.The expansion cohort results confirm robust activity of everolimus plus bevacizumab in metastatic pRCC variants, supporting this regimen as a standard option for this patient population.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ARID1A mutant	renal cell carcinoma	predicted - sensitive	Bevacizumab + Everolimus	Case Reports/Case Series	Actionable	In a Phase II trial, 100% (7/7) of patients with papillary renal cell carcinoma (n=3) or unclassified renal cell carcinoma with papillary features (n=4) harboring ARID1A mutations achieved the primary endpoint of 6-month progression-free survival when treated with the combination of Afinitor (everolimus) and Avastin (bevacizumab) (PMID: 32975815; NCT01399918).	32975815