179264-197

A phase II study of atezolizumab (atezo) with or without bevacizumab (bev) versus sunitinib (sun) in untreated metastatic renal cell carcinoma (mRCC) patients (pts).

Subcategory: 
Category: 
Genitourinary Cancer
Session Type and Session Title: 
General Session 9: Opportunities and Challenges in Systemic Therapy for Advanced Renal Cancer
Poster Session C: Penile, Urethral, and Testicular Cancers; Renal Cell Cancer
Abstract Number: 

431

Poster Board Number: 
Poster Session C Board #B14
Citation: 
J Clin Oncol 35, 2017 (suppl 6S; abstract 431)
Author(s): 
David F. McDermott, Michael B. Atkins, Robert J. Motzer, Brian I. Rini, Bernard J. Escudier, Lawrence Fong, Richard Wayne Joseph, Sumanta K. Pal, Mario Sznol, John D. Hainsworth, Walter Michael Stadler, Thomas E. Hutson, Alain Ravaud, Sergio Bracarda, Cristina Suarez, Toni K. Choueiri, YounJeong Choi, Mahrukh A. Huseni, Gregg Daniel Fine, Thomas Powles; Beth Israel Deaconess Medical Center, Boston, MA; Georgetown Lombardi Comprehensive Cancer Center, Washington, DC; Memorial Sloan Kettering Cancer Center, New York, NY; Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; Institut Gustave Roussy, Villejuif, France; University of California, San Francisco, San Francisco, CA; Mayo Clinic, Jacksonville, FL; City of Hope, Duarte, CA; Yale University School of Medicine, New Haven, CT; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN; The University of Chicago, Chicago, IL; Texas Oncology, Dallas, TX; Groupe Hospitalier Saint Andre - Hopital Saint Andre, Bordeaux Cedex, France; Ospedale San Donato Azienda USL-8, Perugia PG, Italy; Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain; Dana-Farber/Harvard Cancer Center, Boston, MA; Genentech, Inc., South San Francisco, CA; Barts Cancer Institute-Queen Mary University of London, London, United Kingdom

Abstract Disclosures

Abstract: 

Background: While targeting VEGF improves outcomes for mRCC pts, resistance invariably develops, often within the first year. Here, we describe the efficacy and safety of atezo (anti-PD-L1) with bev (anti-VEGF) and atezo monotherapy vs sun (TKI) in first-line mRCC. Methods: Treatment-naïve mRCC pts were enrolled in a hypothesis generating Ph II study (IMmotion150; NCT01984242) and randomized to atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w, atezo alone or sun 50 mg PO QD 4 wk on/2 wk off. Crossover to atezo + bev after disease progression was allowed for pts receiving atezo or sun. PD-L1 expression was scored on tumor-infiltrating immune cells (IC, SP142 IHC assay). Coprimary endpoints were PFS (RECIST v1.1 by independent review [IRF]) in ITT pts and pts with PD-L1 expression on ≥ 1% of IC (PD-L1+). Results: Baseline characteristics were comparable across arms and between ITT and PD-L1+ pts. The majority of sun and atezo pts subsequently received atezo + bev. Median survival follow up was 20.7 mo. The PFS HR in ITT pts for atezo + bev vs sun was 1.00 and 1.19 for atezo vs sun. In PD-L1+ pts, the PFS HR for atezo + bev vs sun was 0.64 and 1.03 for atezo vs sun (table). Tx-related Gr 3-4 AEs were seen in 40%, 16% and 57% of pts in the atezo + bev, atezo and sun arms, respectively. AEs leading to death occurred in 3%, 2% and 2% of pts, respectively. Conclusion: Atezo + bev resulted in encouraging antitumor activity in the PD-L1+ subgroup of first-line RCC pts. Atezo + bev safety is consistent with the known profile of atezo and bev individually. The clinical benefit of atezo + bev vs sun will be evaluated in the ongoing Ph III study IMmotion151 (NCT02420821). Clinical trial information: NCT01984242

Atezo + Bev
n = 101
Atezo
n = 103
Sun
n = 101
Atezo + Bev
vs Sun
Atezo
vs Sun
mPFSa, mo (95% CI)
HR (95% CI)
ITT N = 30511.7
(8.4, 17.3)
6.1
(5.4, 13.6)
8.4
(7.0, 14.0)
1.00
(0.69, 1.45)
P = .982
1.19
(0.82, 1.71)
P = .358
PD-L1+ n = 16414.7
(8.2, 25.1)
5.5
(3.0, 13.9)
7.8
(3.8, 10.8)
0.64
(0.38, 1.08)
P = .095
1.03
(0.63, 1.67)
P = .917
12-mo PFSa, %
ITT504142--
PD-L1+523734--
ORRa (confirmed), n (%), 95% CI
ITT32 (32%)
(23, 42)
26 (25%)
(17, 35)
29 (29%)
(20, 39)
--
PD-L1+23 (46%)
(32, 61)
15 (28%)
(16, 42)
16 (27%)
(16, 40)
--

a Assessed by IRF. P values for descriptive purposes only.