Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Presidential Symposium 2

3281 - JAVELIN Renal 101: a randomized, phase 3 study of avelumab + axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma (aRCC)


21 Oct 2018


Presidential Symposium 2


Cytotoxic Therapy;  Immunotherapy

Tumour Site

Renal Cell Cancer


Robert Motzer


R.J. Motzer1, K. Penkov2, J.B.A.G. Haanen3, B.I. Rini4, L. Albiges5, M.T. Campbell6, C.K. Kollmannsberger7, S. Negrier8, M. Uemura9, J.L. Lee10, H. Gurney11, R. Berger12, M. Schmidinger13, J. Larkin14, M.B. Atkins15, J. Wang16, P.B. Robbins17, A. Chudnovsky18, A. Di Pietro19, T.K. Choueiri20

Author affiliations

  • 1 Medicine, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Medical Oncology, Private Medical Institution "Euromedservice", St. Petersburg/RU
  • 3 Division Of Medical Oncology, The Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 4 Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 5 Department Of Cancer Medicine, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 6 Department Of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston/US
  • 7 Medical Oncology, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 8 D'oncologie Médicale, Centre Léon Bérard, 69008 - Lyon/FR
  • 9 Medical Oncology, Osaka University Hospital, Osaka/JP
  • 10 Department Of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul/KR
  • 11 Medicine And Health Sciences, Macquarie University, 2109 - Macquarie Park/AU
  • 12 Institute Of Onocology And Radiotherapy, Chaim Sheba Medical Center, 52621 - Ramat Gan/IL
  • 13 Department Of Medicine I, Clinical Division Of Oncology And Comprehensive Cancer Center, Medical University of Vienna, 1090 - Vienna/AT
  • 14 Department Of Medical Oncology, Royal Marsden NHS Foundation Trust, London/GB
  • 15 Oncology & Medicine, Georgetown-Lombardi Comprehensive Cancer Center, 20007 - Washington DC/US
  • 16 Oncology, Pfizer, Cambridge/US
  • 17 Translational Oncology, Pfizer, San Diego/US
  • 18 Immuno-oncology, Pfizer, Cambridge/US
  • 19 Immuno-oncology, Pfizer, Milan/IT
  • 20 Medical Oncology, The Lank Center for Genitourinary Oncology Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3281


In a phase 1b trial, 1L A + Ax had encouraging antitumor activity for patients (pts) with aRCC (Lancet Oncol. 2018;19:451).


Eligible pts with clear-cell aRCC, ECOG ≤ 1, and no prior systemic therapy were randomized 1:1 (stratified by ECOG and geographic region) to receive A 10 mg/kg IV Q2W + Ax 5 mg PO BID in 6-wk cycles or S 50 mg PO QD on schedule 4/2; all prognostic risk groups were included. Primary endpoints were progression-free survival (PFS; by blinded independent central review [BICR] per RECIST v1.1) and overall survival (OS) in pts with PD-L1+ tumors (≥ 1% of immune cells). Secondary endpoints included PFS by BICR and OS irrespective of PD-L1 expression, objective response (OR), and safety.


As of 20 Jun 2018, 886 pts were randomized (A + Ax: N = 442; S: N = 444); of these, 21%/62%/16% had favorable/intermediate/poor IMDC risk criteria (not reported in < 1%). In 560 pts (63.2%) with PD-L1+ tumors, median PFS was 13.8 vs 7.2 mo in A + Ax vs S arms, respectively (HR = 0.61; p < .0001; Table). Median PFS in pts irrespective of PD-L1 expression was 13.8 vs 8.4 mo (HR = 0.69; p = .0001). PFS and OR results favored A + Ax in pts irrespective of PD-L1 expression and in all MSKCC/IMDC prognostic risk groups. OS data were immature at data cutoff (< 16% of pts with events). In A + Ax vs S arms, grade ≥3 treatment-emergent adverse events occurred in 71.2% vs 71.5% of pts and led to discontinuation of any study drug in 22.8% vs 13.4%; deaths due to study treatment toxicity occurred in 0.7% vs 0.2% of pts.

Pts with PD-L1+ tumors

A + Ax (N = 270)

S (N = 290)

PFS per BICR (primary endpoint)

Median (95% CI), mo

Stratified hazard ratio (95% CI); 1-sided p value

13.8 (11.1, not estimable)

7.2 (5.7, 9.7)

0.61 (0.475, 0.790); p < .0001

Confirmed objective response rate per BICR

Objective response rate (95% CI), %

Stratified odds ratio (95% CI); 1-sided p value

55.2 (49.0, 61.2)

25.5 (20.6, 30.9)

3.732 (2.532, 5.371); p < .0001

Pts irrespective of PD-L1 expression

A + Ax (N = 442)

S (N = 444)


Median (95% CI), mo

Stratified hazard ratio (95% CI); 1-sided p value

13.8 (11.1, not estimable)

8.4 (6.9, 11.1)

0.69 (0.563, 0.840); p = .0001

Confirmed objective response rate per BICR

Objective response rate (95% CI), %

Stratified odds ratio (95% CI); 1-sided p value

51.4 (46.6, 56.1)

25.7 (21.7, 30.0)

3.098 (2.300, 4.148); p < .0001


This randomized phase 3 trial met its primary objective of significantly improving PFS in pts with PD-L1+ aRCC treated with A + Ax vs S. PFS and OR benefit was also observed in pts irrespective of PD-L1 expression and across all prognostic risk groups. The safety profiles were consistent with those of prior studies of each drug. These results support A + Ax as a potential new 1L standard-of-care for pts with aRCC.

Clinical trial identification

Clinical Trial Number: NCT02684006

Editorial Acknowledgement

Medical writing support was provided by ClinicalThinking Inc., Hamilton, NJ, USA.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.