Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

First-line avelumab/axitinib for RCC benefits wide range of patients

Choueiri TK et al. GUCS 2019, Abstract 544.

Key clinical point: Efficacy of first-line avelumab/axitinib in RCC is seen across diverse patient and disease characteristics.

Major finding: Compared with sunitinib, avelumab/axitinib yielded better progression-free survival across IMDC risk groups (hazard ratios, 0.539-0.736), MSKCC risk groups (HRs, 0.495-0.715), and PD-L1 statuses (HRs, 0.626-0.827).

Study details: Subgroup analyses of a phase 3 randomized, controlled trial among 886 patients with treatment-naive advanced RCC (JAVELIN Renal 101 trial).

Disclosures: Dr. Choueiri disclosed that he receives honoraria from, has a consulting or advisory role with, and receives institutional research funding from Merck and Pfizer – among other disclosures. The trial was sponsored by Pfizer.


Choueiri TK et al. GUCS 2019, Abstract 544.


“For first-line therapy of metastatic clear-cell renal cancer, we now have two regimens that have demonstrated a survival advantage over first-line sunitinib,” Walter M. Stadler, MD, said in an interview. For first-line therapy, there is the combination of nivolumab and ipilimumab in intermediate- and poor-risk patients and also the combination of pembrolizumab and axitinib.

The combination of avelumab and axitinib in JAVELIN Renal 101 “demonstrates a progression free – but not yet an overall survival – advantage. Whether this is due to the immaturity of the data, crossover to immunotherapy in the control group, or a true difference in these regimens remains to be determined. Comparative studies, and studies evaluating less-aggressive dosing regimens for these expensive drugs are needed” he said.

Dr. Stadler is the Fred C. Buffett Professor of Medicine and Surgery, chief of the section of hematology/oncology, director of the genitourinary oncology program, and deputy director of the Comprehensive Cancer Center at the University of Chicago.