Patient-reported outcomes (PROs) in IMmotion150: Atezolizumab (atezo) alone or with bevacizumab (bev) versus sunitinib (sun) in first-line metastatic renal cell carcinoma (mRCC).

Authors

Sumanta Pal

Sumanta K. Pal

City of Hope National Medical Center, Duarte, CA

Sumanta K. Pal , David F. McDermott , Michael B. Atkins , Bernard Escudier , Brian I. Rini , Robert J. Motzer , Lawrence Fong , Richard Wayne Joseph , Stephane Oudard , Alain Ravaud , Sergio Bracarda , Cristina Suarez Rodriguez , Elaine Tat Lam , Toni K. Choueiri , Beiying Ding , Caroleen Quach , Kenji Hashimoto , Christina Schiff , Elisabeth Piault , Thomas Powles

Organizations

City of Hope National Medical Center, Duarte, CA, Beth Israel Deaconess Medical Center, Boston, MA, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, Gustave Roussy, Villejuif, France, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, Memorial Sloan Kettering Cancer Center, New York, NY, University of California San Francisco, San Francisco, CA, Mayo Clinic Hospital, Jacksonville, FL, Paris Descartes University, Paris, France, CHU Hopitaux de Bordeaux-Hôpital Saint-André, Bordeaux, France, Ospedale San Donato, Arezzo, Italy, Vall d’Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain, University of Colorado Cancer Center, Denver, CO, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA, Genentech, Inc., South San Francisco, CA, Roche Products Ltd., Welwyn Garden City, United Kingdom, Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: The phase 2 IMmotion150 study showed improved PFS with atezo + bev vs sun in patients (pts) whose tumors were PD-L1+ and corroborated the activity of atezo monotherapy in previously untreated mRCC. This study offers an opportunity to evaluate PROs with immunotherapy and VEGF-directed therapy alone and in combination. Methods: Pts randomized to atezo 1200 mg IV q3w alone or with bev 15 mg/kg IV q3w, or sun 50 mg po qd for 4 wk on/2 wk off completed the MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) q3w of each 6-wk cycle until progression (RECIST 1.1). Time to deterioration (TTD; first ≥ 2-point score increase over baseline [BL]) and change from BL (effect size [ES] ≥ 0.2 suggests a clinically important difference vs sun) in MDASI symptom severity and interference and BFI fatigue severity and interference scores are reported for all-comers. Results: Completion rates were > 90% at BL and ≥ 80% at most visits across arms. BL PRO scores indicating mild symptoms and interference were similar across arms. Delayed TTD of symptom severity and interference with daily life was seen with atezo vs sun and atezo + bev vs sun and was longest with atezo alone (Table). Pts reported milder symptoms and less interference during the first 6 cycles with atezo vs sun: ES mean (range) was 0.36 (0.07-0.68) for core symptom severity and 0.36 (0.04-0.83) for symptom interference. The 5 worst pt-reported symptoms during tx (dry mouth, fatigue, rash, drowsiness, lack of appetite) were all in the sun arm; all 16 symptoms measured were milder with atezo vs sun. Conclusions: PROs suggest that atezo alone or with bev maintained daily function with minimal symptom interference vs sun. Clinical activity, safety and PRO data for atezo support its investigation in adjuvant tx of high-risk RCC pts (IMmotion010; NCT03024996). Clinical trial information: NCT01984242

TTD: HR (95% CI) vs Sun.

AtezoAtezo + Bev
MDASI core symptom severity0.39 (0.22, 0.71)0.74 (0.45, 1.20)
MDASI RCC symptom severity0.22 (0.12, 0.41)0.60 (0.38, 0.94)
MDASI symptom interference0.36 (0.22, 0.58)0.70 (0.47, 1.04)
BFI fatigue severity0.48 (0.33, 0.70)0.75 (0.53, 1.06)
BFI fatigue interference0.38 (0.24, 0.60)0.67 (0.46, 0.99)

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Kidney Cancer

Clinical Trial Registration Number

NCT01984242

Citation

J Clin Oncol 37, 2019 (suppl; abstr 4515)

DOI

10.1200/JCO.2019.37.15_suppl.4515

Abstract #

4515

Poster Bd #

341

Abstract Disclosures