LBA66 - IMmotion010: Efficacy and safety from the phase III study of atezolizumab (atezo) vs placebo (pbo) as adjuvant therapy in patients with renal cell carcinoma (RCC) at increased risk of recurrence after resection

Background

The standard of care for loco-regional RCC is nephrectomy, but many patients (pts) experience recurrence. IMmotion010, a Phase III, multicentre, randomised, pbo-controlled, double-blinded trial, evaluated atezo (anti-PD-L1) monotherapy as adjuvant therapy in pts with RCC and increased risk of recurrence after resection.

Methods

Key eligibility criteria included pts with RCC with a clear-cell or sarcomatoid component and who had increased risk of recurrence (T2 Grade [Gr] 4, T3a Gr 3/4, T3b/c or T4 any Gr, TxN+ any Gr or M1 resected with no evidence of disease). Pts were randomised 1:1 to atezo 1200 mg IV q3w or pbo IV q3w for 16 cycles or 1 year. The primary endpoint was investigator (INV)-assessed disease-free survival (DFS). Secondary endpoints included OS and independent review facility (IRF)-assessed DFS in the ITT population, and INV-DFS and IRF-DFS in pts with PD-L1 immune cell expression ≥1% (VENTANA SP142 IHC assay).

Results

From 3 Jan 2017 to 15 Feb 2019, 778 pts were randomised to atezo (n=390) or pbo (n=388). At primary analysis data cutoff (3 May 2022), median follow-up was 44.7 mo and minimum follow-up was 38.6 mo. No pts remain on study treatment. Baseline characteristics were generally balanced between arms. Median INV-DFS was 57.2 mo (95% CI: 44.6, NE) for atezo and 49.5 mo (47.4, NE) for pbo (HR: 0.93; 95% CI: 0.75, 1.15; P=0.495). Key secondary endpoints are in the Table. In the safety population, Gr 3/4 adverse events (AEs) occurred in 27% (106/390) and 21% (81/383) of pts receiving atezo or pbo, respectively; Gr 5 AEs occurred in <1% (1/390) and <1% (3/383), none related to treatment.

Conclusions

Atezo as adjuvant therapy after resection for pts with RCC with increased risk of recurrence did not improve clinical outcomes vs pbo in the ITT population but had a manageable safety profile. Subgroup data will be presented. Table Table: 000LBA66

DFS, disease-free survival; ITT, intention-to-treat; NE, not estimable; OS, overall survival.

Clinical trial identification

NCT03024996.

Editorial acknowledgement

Medical writing assistance was provided by Scott Battle, PhD, of Health Interactions and funded by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

A. Bex: Financial Interests, Institutional, Research Grant, Restricted educational grant for an investigator initiated trial of neoadjuvant therapy in high risk renal cancer: Pfizer; Non-Financial Interests, Principal Investigator, Steering committee member and PI in an adjuvant trial: Roche/Genentech; Non-Financial Interests, Principal Investigator, Steering committee member and local investigator in an adjuvant trial: BMS; Non-Financial Interests, Advisory Role, Medical Steering committee member to advise the patient advocacy group on medical topics and strategy: International Kidney Cancer Coalition, KIdney Cancer Association. R. Uzzo: Financial Interests, Personal, Advisory Role: Pfizer, Merck. J.A. Karam: Financial Interests, Personal, Other, Honoraria: Pfizer, Merck, Roche/Genentech, J&J; Financial Interests, Personal, Advisory Role: Pfizer, Merck, Roche/Genentech, J&J; Financial Interests, Institutional, Sponsor/Funding: Roche/Genentech, Mirati, Merck, Elypta; Financial Interests, Personal, Stocks/Shares: MedTek, ROM Technologies. V.A. Master: Financial Interests, Personal, Advisory Role: Pfizer, Merck, BMS, Ethicon. F. Donskov: Financial Interests, Institutional, Research Grant: Pfizer, MSD, Ipsen. C. Suárez: Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Role: Pfizer, Roche, Astellas, Ipsen, Sanofi, Bayer, MSD; Financial Interests, Institutional, Speaker’s Bureau: Bristol-Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Roche, Astellas, Ipsen; Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Other, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Financial Interests, Personal, Other, Travel/Accommodation/Expenses: Pfizer, Roche. L. Albiges: Financial Interests, Institutional, Other, Consulting: Astellas, AstraZeneca, BMS, EISAI, Ipsen, Janssen, MSD, Merck, Novartis, Pfizer; Non-Financial Interests, Principal Investigator: Pfizer, BMS, Ipsen, AVEO, AstraZeneca, MSD; Non-Financial Interests, Other, Clinical trial steering committee: Roche, Exelixis; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Other, Medical Steering Committee: Kidney Cancer Association; Non-Financial Interests, Other, Member of the Renal Cell Carcinoma Guidelines Panel: European Association of Urology (EAU); Non-Financial Interests, Other, Member of the Kidney Cancer Research Summit scientific committee 2021: Kidney Can; Other, Other, Scientific Committee: BMS France. B.I. Rini: Financial Interests, Personal, Advisory Board: Merck, BMS, AVEO, Alkermes, Pfizer, Eisai, Corvus, EUSA, Allogene, Debiopharm, Athenex, Surface Oncology, Genentech/Roche; Financial Interests, Personal, Stocks/Shares: PTC Therapeutics; Financial Interests, Institutional, Invited Speaker: Merck, Pfizer, Astra-Zeneca, Pionyr, Surface Oncology; Financial Interests, Institutional, Other, Research funding to institution: BMS, Arrowhead, Aravive; Financial Interests, Institutional, Funding: AVeo. Y. Tomita: Financial Interests, Personal, Invited Speaker: Astellas, BMS, Merk, Ono; Financial Interests, Institutional, Research Grant: Chugai, Ono; Non-Financial Interests, Advisory Role: Eisai, Ono. G. Procopio: Financial Interests, Personal, Advisory Board, consultant fees: Astellas, AstraZeneca, Bayer, BMS, Janssen, Ipsen, Merck, MSD, Novartis, Pfizer; Financial Interests, Institutional, Research Grant, research funding for no profit clinical trial: Opsen. M. Zibelman: Financial Interests, Personal, Advisory Role: Pfizer, EMD Serono, Exelixis, Janssen, Blue Earth; Financial Interests, Institutional, Research Grant: BMS, Exelixis. M. Huseni: Financial Interests, Personal, Full or part-time Employment: Genentech. D. Basu: Financial Interests, Personal, Full or part-time Employment: Roche. B. Ci: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Genentech. W. Leung: Financial Interests, Personal, Full or part-time Employment: Genentech. O. Khan: Financial Interests, Personal, Full or part-time Employment: Roche. S.K. Pal: Financial Interests, Personal, Advisory Role: Astellas Pharma, Aveo, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, Ipsen, Myriad Pharmaceuticals, Novartis, Pfizer. All other authors have declared no conflicts of interest.