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ASCO 2018

ASCO 2018: Patient-reported Outcomes in IMmotion151: Atezolizumab + Bevacizumab vs Sunitinib in Treatment Naive mRCC

Chicago, IL (UroToday.com) At GU ASCO earlier this year in San Francisco, Robert Motzer, MD, presented the first results of the IMmotion151, a randomized, open-label phase III study assessing atezolizumab + bevacizumab vs sunitinib in treatment naive mRCC patients [1]. IMmotion151 met its co-primary endpoint in PD-L1+ patients with improvement in investigator-assessed progression-free survival (PFS) for patients receiving atezolizumab + bevacizumab compared to sunitinib (HR 0.74, 95%CI 0.57-0.96; median PFS 11.2 vs 7.7 months). There were also encouraging efficacy results observed in the intent-to-treat population: atezolizumab + bevacizumab vs sunitinib HR 0.83 95%CI 0.70-0.97; median PFS 11.2 vs 8.4 months. On the interim analysis, there was no difference in OS between the two arms. The median treatment duration was 12.0 months (range 0-26.2) for patients receiving atezolizumab + bevacizumab compared to 9.2 months (range 0-26.6) for those receiving sunitinib. Grade 3-4 adverse events were slightly higher in the sunitinib arm (54% vs 40%). Bernard Escudier, MD presented results of the patient reported outcomes (PROs) among those enrolled in IMmotion151 to document patient perspective on overall clinical benefit for each treatment arm.

Patients enrolled in IMmotion151 received atezolizumab 1200 mg IV every three weeks + bevacizumab 15 mg/kg IV every three weeks (n = 454) or sunitinib 50 mg PO every day for 4 weeks on/2 weeks off (n = 461). Patients completed two PRO metrics, including: 

MD Anderson Symptom Inventory (MDASI) – at days 1 and 22 of each 6-week cycle, at the end of treatment, and during follow-up. MDASI measured:
  • Symptom severity: How do patients experience symptoms?
  • Symptom interference: Do symptoms impair patient’s day-to-day life?
Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) – at days 1 and 22 of each 6-week cycle, at the end of treatment, and during follow-up. FKSI-19 measured:
  • Overall side-effect burden: How bothered are patients by their treatment side effects?
  • HRQoL: What is the impact of disease and treatment on patient’s quality of life?
Completion rates for these metrics were high (>80%) at baseline and remained ≥70% in each arm through week 54. Descriptive analyses included summary statistics for scores (effect sizes ≥ 0.3 suggest clinically meaningful differences), score changes from baseline, and time to deterioration (first ≥ 2-point score increase in MDASI interference). With regards to symptoms severity, 17 disease and treatment-related symptoms were assessed, including: mouth/throat sores, rash or skin changes, diarrhea, nausea, lack of appetite, vomiting, shortness of breath, fatigue, disturbed sleep, pain, numbness or tingling, headache, dry mouth, distress, sad feelings, drowsiness, and difficulty remember things. Score ranges for each symptom were recorded as 0 (not present) to 10 (most severe).

For symptom severity during study treatment, baseline scores were similar between the two groups, indicating no/mild symptoms. Patients in the atezolizumab + bevacizumab arm reported milder symptoms for the 17 symptoms assessed. For change in symptom interference with daily living, baseline symptoms were also comparable between patients receiving atezolizumab + bevacizumab or sunitinib. Similar to symptom severity, patients receiving atezolizumab + bevacizumab had less interference of symptoms with day-to-day life at most visits compared to patients receiving sunitinib. Time to deterioration in symptom interference was also delayed for those receiving atezolizumab + bevacizumab (HR 0.56, 95%CI 0.46-0.68): median for atezolizumab + bevacizumab was 11.3 months vs 4.3 months for sunitinib. Finally, a greater proportion of atezolizumab + bevacizumab treated patients reported no or little bother from treatment side effects vs sunitinib treated patients.

Escudier concluded his presentation with several important take-home points:

  • In addition to IMmotion151 meeting its co-primary endpoint, all PROs favored atezolizumab + bevacizumab vs sunitinib
  • Improved PROs included: milder symptoms, less functional impairment, delay in meaningful deterioration of patient’s daily functioning, less treatment-related side effects, and better HRQoL
  • PROs further support the positive benefit-risk of atezolizumab + bevacizumab vs sunitinib as a first-line treatment option in mRCC
Clinical trial information: NCT02420821


References:
1. Motzer RJ, Powles T, Atkins MB, et al. IMmotion 151: A Randomized Phase III Study of Atezolizumab plus Bevacizumab vs Sunitinib in Untreated Metastatic Renal Cell Carcinoma (mRCC). J Clin Oncol 2018;36(suppl 6S; abstr 578).


Presented by: Bernard Escudier, MD, U1015 INSERM, Gustave Roussy Cancer Campus, Paris Saclay University, Villejuif, France

Co-Authors: Robert J. Motzer, Brian I. Rini, Thomas Powles, David F. McDermott, Cristina Suarez, Sergio Bracarda, Walter Michael Stadler, Frede Donskov, Howard Gurney, Stephane Oudard, Motohide Uemura, Elaine Tat Lam, Carsten Grüllich, Beiying Ding, Tarik Khaznadar, Caroleen Quach, Elisabeth Piault, Christina Schiff, Michael B. Atkins; Memorial Sloan Kettering Cancer Center, New York, NY; Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; Barts Cancer Institute, Queen Mary University of London, London, United Kingdom; Beth Israel Deaconess Medical Center, Boston, MA; Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain; Ospedale San Donato, Arezzo, Italy; University of Chicago, Chicago, IL; Aarhus University Hospital, Aarhus, Denmark; Macquarie University, Sydney, New South Wales, Australia; Paris Descartes University, Paris, France; Osaka University Graduate School of Medicine, Osaka, Japan; University of Colorado, Aurora, CO; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Genentech, Inc., South San Francisco, CA; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Genentech, Inc., San Francisco, CA; Georgetown Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington, DC

Written by: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the 2018 ASCO Annual Meeting - June 1-5, 2018 – Chicago, IL USA