Upcoming event

Subgroup analysis from JAVELIN Renal 101: Outcomes for avelumab plus axitinib (A + Ax) versus sunitinib (S) in advanced renal cell carcinoma (aRCC)

  • Toni K. Choueiri,
  • Robert J. Motzer,
  • Matthew T. Campbell,
  • Boris Y. Alekseev,
  • Motohide Uemura,
  • Christian K. Kollmannsberger,
  • Gwenaelle Gravis,
  • Georg A. Bjarnason,
  • Howard Gurney,
  • Jinsoo Chung,
  • John B. A. G. Haanen,
  • Brian I. Rini,
  • James M. G. Larkin,
  • Manuela Schmidinger,
  • Franco Nole,
  • Aleksander Chudnovsky,
  • Bo Huang,
  • Subramanian Hariharan,
  • Alessandra di Pietro,
  • Laurence Albiges


In the ongoing phase 3 JAVELIN Renal 101 trial, progression-free survival (PFS) was longer (median, 13.8 vs 8.4 mo; hazard ratio, 0.69; p=0.0001) and the objective response rate (ORR) was higher (51% vs 26%) with A + Ax vs S in patients with previously untreated aRCC. Here we report outcomes from an analysis of several prespecified subgroups.

Patients were randomized 1:1 to receive A (10 mg/kg) IV every 2 weeks + Ax (5 mg) PO twice daily or S (50 mg) PO once daily for 4 wk (6-wk cycle). Primary and key secondary endpoints were PFS per independent review committee (IRC; RECIST v1.1) and OS in patients with PD-L1+ tumors (≥1% of immune cells) and in patients irrespective of PD-L1 expression; other secondary endpoints included OR per IRC (RECIST v1.1).

A total of 886 patients were randomized; 560 (63%) had PD-L1+ tumors. At data cut-off (Jun 2018), median follow-up was 12.0 vs 11.5 mo for A + Ax vs S groups. The table shows PFS and ORR by MSKCC and IMDC risk groups (F, favorable; I, intermediate; P, poor) and PD-L1 subgroup. Similar results for prognostic risk were seen in patients with PD-L1+ tumors. Outcome data (including PFS2) for additional clinical subgroups by baseline demographics and features will be presented. Clinical trial information: NCT02684006

A + Ax demonstrated PFS and OR benefit across all prognostic risk groups and PD-L1 subgroups vs S in aRCC.


, not estimable