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Clinical Trial
. 2022 Oct 1;400(10358):1103-1116.
doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.

Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial

Sumanta Kumar Pal  1 , Robert Uzzo  2 , Jose Antonio Karam  3 , Viraj A Master  4 , Frede Donskov  5 , Cristina Suarez  6 , Laurence Albiges  7 , Brian Rini  8 , Yoshihiko Tomita  9 , Ariel Galapo Kann  10 , Giuseppe Procopio  11 , Francesco Massari  12 , Matthew Zibelman  13 , Igor Antonyan  14 , Mahrukh Huseni  15 , Debasmita Basu  16 , Bo Ci  15 , William Leung  15 , Omara Khan  16 , Sarita Dubey  15 , Axel Bex  17
Affiliations
Clinical Trial

Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial

Sumanta Kumar Pal et al. Lancet. .

Abstract

Background: The standard of care for locoregional renal cell carcinoma is surgery, but many patients experience recurrence. The objective of the current study was to determine if adjuvant atezolizumab (vs placebo) delayed recurrence in patients with an increased risk of recurrence after resection.

Methods: IMmotion010 is a randomised, double-blind, multicentre, phase 3 trial conducted in 215 centres in 28 countries. Eligible patients were patients aged 18 years or older with renal cell carcinoma with a clear cell or sarcomatoid component and increased risk of recurrence. After nephrectomy with or without metastasectomy, patients were randomly assigned (1:1) to receive atezolizumab (1200 mg) or placebo (both intravenous) once every 3 weeks for 16 cycles or 1 year. Randomisation was done with an interactive voice-web response system. Stratification factors were disease stage (T2 or T3a vs T3b-c or T4 or N+ vs M1 no evidence of disease), geographical region (north America [excluding Mexico] vs rest of the world), and PD-L1 status on tumour-infiltrating immune cells (<1% vs ≥1% expression). The primary endpoint was investigator-assessed disease-free survival in the intention-to-treat population, defined as all patients who were randomised, regardless of whether study treatment was received. The safety-evaluable population included all patients randomly assigned to treatment who received any amount of study drug (ie, atezolizumab or placebo), regardless of whether a full or partial dose was received. This trial is registered with ClinicalTrials.gov, NCT03024996, and is closed to further accrual.

Findings: Between Jan 3, 2017, and Feb 15, 2019, 778 patients were enrolled; 390 (50%) were assigned to the atezolizumab group and 388 (50%) to the placebo group. At data cutoff (May 3, 2022), the median follow-up duration was 44·7 months (IQR 39·1-51·0). Median investigator-assessed disease-free survival was 57·2 months (95% CI 44·6 to not evaluable) with atezolizumab and 49·5 months (47·4 to not evaluable) with placebo (hazard ratio 0·93, 95% CI 0·75-1·15, p=0·50). The most common grade 3-4 adverse events were hypertension (seven [2%] patients who received atezolizumab vs 15 [4%] patients who received placebo), hyperglycaemia (ten [3%] vs six [2%]), and diarrhoea (two [1%] vs seven [2%]). 69 (18%) patients who received atezolizumab and 46 (12%) patients who received placebo had a serious adverse event. There were no treatment-related deaths.

Interpretation: Atezolizumab as adjuvant therapy after resection for patients with renal cell carcinoma with increased risk of recurrence showed no evidence of improved clinical outcomes versus placebo. These study results do not support adjuvant atezolizumab for treatment of renal cell carcinoma.

Funding: F Hoffmann-La Roche and Genentech, a member of the Roche group.

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Conflict of interest statement

Declaration of interests SKP reports advisory or consulting fees from Pfizer, Novartis, Aveo, Myriad Pharmaceuticals, Genentech, Exelixis, Bristol Myers Squibb, Astellas Pharma, Ipsen, and Eisai; and travel support from CRISPR Therapeutics and Roche. RU reports receiving advisory or consulting fees from Pfizer, Merck, and Haymarket Media. JAK reports research grants or funding paid to their institution from Roche/Genentech, Mirati, Merck, and Elypta; consulting fees from Pfizer, Merck, Roche or Genentech, and Johnson & Johnson; participation on a data safety monitoring board or advisory board for Pfizer; and stock ownership or stock options in MedTek and ROM Technologies. VAM reports advisory or consulting fees from Pfizer, Merck, Bristol Myers Squibb, and Ethicon; and participation on a data safety monitoring board or advisory board for Pfizer, Merk, Bristol Myers Squibb, and Ethicon. CS reports grants from Roche; advisory or consulting fees from Bristol Myers Squibb, Ipsen, Astella, Sanofi, Bayer, Merck Sharp, Dohme, and Pfizer; and support for travel from Bristol Myers Squibb, Roche, and Pfizer. LA reports research grants or funding paid to their institution from Bristol Myers Squibb; consulting fees paid to their institution from Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, Merck, Merck Sharpe & Dohme, Novartis, Pfizer, and EISAI; and payment or honoraria paid to their institution from Astella, Bristol Myers Squibb, Ipsen, and Merck Sharpe & Dohme. BR reports payment of grants or contracts to their institution from Pfizer, Roche, Incyte, AstraZeneca, Seattle Genetics, Arrowhead Pharmaceuticals, Immunomedics, Bristol Myers Squibb, Mirati Therapeutics, Merck, Surface Oncology, Aravive, Exelixis, Janssen, Pionyr, and Genentech/Roche; advisory or consulting fees from Bristol Myers Squibb, Pfizer, Genentech/Roche, Aveo, Synthorx, Merck, Corvus, Surface Oncology, Aravive, Alkermes, Arrowhead, Shionogi, Eisai, Nikang Therapeutics, EUSA, Athenex, Allogene Therapeutics, and Debiopharm; travel support from Merck and Bristol Myers Squibb; and stock ownership or stock options in PTC Therapeutics. YT reports research funding from Astellas Pharma, Chugai Pharmaceutical, Ono Pharmaceutical, Pfizer, and Takeda; and payment or honoraria from Astella, Bristol Myers Squibb, Chugai Pharmaceuticals, Novartis, and Ono Pharmaceutical. AGK reports advisory or consulting fees from Janssen, Zodiac, and Pfizer; and travel support from Janssen, Ipsen, and AstraZeneca. GP reports payment or honoraria from AstraZeneca, Bayer, BMS, Eisai, Janssen, Ipsen, Merck, Merck Sharpe & Dohme, Novartis, Pfizer, and Roche; and travel support from Ipsen and Janssen. MZ reports grants from Bristol Myers Squibb and Exelixis; and advisory or consulting fees from Pfizer, EMD Serono, Exelixis, Janssen, and Blue Earth. MH, BC, WL, and SD are employees of Genentech, and report stock ownership or stock options. DB is an employee of F Hoffmann-La Roche. OK is an employee of F Hoffmann-La Roche, and reports stock ownership or stock options. AB reports a restricted research grant payment to their institution from Pfizer; payment to their institution for attending steering committee meetings from Roche/Genentech; and payment to their institution for participation on the data safety monitoring board of Merck Sharpe & Dohme. All other authors declare no competing interests.

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