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IMmotion151: A Randomized Phase III Study of Atezolizumab Plus Bevacizumab vs Sunitinib in Untreated Metastatic Renal Cell Carcinoma (mRCC)
Abstract
578 Background: Atezolizumab (atezo; anti–PD-L1) + bevacizumab (bev; anti-VEGF) showed first-line (1L) anti-tumor activity with a manageable safety profile in PD-L1+ mRCC pts in a Phase II study (McDermott ASCO-GU 2017). Here we describe the first randomized Phase III trial of a PD-L1/PD-1 pathway inhibitor combined with an anti-VEGF agent in 1L mRCC. Methods: IMmotion151 (NCT02420821) enrolled treatment-naïve pts regardless of prognostic risk group randomized 1:1 to receive atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sunitinib (sun) 50 mg PO QD 4 wk on/2 wk off. Pts were stratified by PD-L1 status (< 1% vs ≥ 1% PD-L1 expression on tumor-infiltrating immune cells [IC]; SP142 IHC assay). Coprimary endpoints: progression-free survival (PFS; by investigator per RECIST v1.1) in PD-L1+ pts (≥ 1% IC) and overall survival (OS) in intent-to-treat (ITT) pts. Secondary endpoints included PFS in ITT pts, ORR and DOR. Results: Baseline characteristics were comparable between arms within PD-L1+ (40% of ITT) and ITT pts. Median survival follow-up was 15 mo. PFS HR for atezo + bev vs sun was 0.74 (95% CI 0.57, 0.96) in PD-L1+ pts and 0.83 (95% CI 0.70, 0.97) in ITT pts. OS was immature at first interim analysis. PFS benefit was consistent across analyzed subgroups, including MSKCC risk, liver metastases and sarcomatoid histology. In PD-L1+ pts, ORR was 43% and DOR was not reached for atezo + bev vs 35% and 12.9 mo for sun. 40% of atezo + bev–treated pts and 54% of sun-treated pts had treatment-related Gr 3-4 AEs; 12% and 8% of treatment-related all-Gr AEs led to discontinuation, respectively. Conclusions: The study showed longer PFS for atezo + bev vs sun in PD-L1+ pts. Improved PFS was also observed in ITT pts. Safety was consistent with that of the individual agents. These results support the use of atezo + bev as a 1L treatment option in mRCC. Clinical trial information: NCT02420821. [Table: see text]
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Rini, B. I., Plimack, E. R., Stus, V., Gafanov, R., Hawkins, R., Nosov, D., Pouliot, F., Alekseev, B., Soulières, D., Melichar, B., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816714 · Cited by 3,403
Self-citationMcDermott, D. F., Huseni, M. A., Atkins, M. B., Motzer, R. J., Rini, B. I., Escudier, B., Fong, L., Joseph, R. W., Pal, S. K., Reeves, J. A., et al. (2018) · Nature Medicine · doi:10.1038/s41591-018-0053-3 · Cited by 1,260
Self-citationGarcia, J., Hurwitz, H. I., Sandler, A. B., Miles, D., Coleman, R. L., Deurloo, R., & Chinot, O. L. (2020) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2020.102017 · Cited by 1,159
Metadata
- Authors
- Motzer, R. J., Powles, T., Atkins, M. B., Escudier, B., McDermott, D. F., Suarez, C., Bracarda, S., Stadler, W. M., Donskov, F., Lee, J.-L., Hawkins, R. E., Ravaud, A., Alekseev, B. Y., Staehler, M. D., Uemura, M., Donaldson, F., Li, S., Huseni, M. A., Schiff, C., & Rini, B. I.
- Venue
- Journal of Clinical Oncology
- Published
- 2018-02-20
- Volume
- 36
- Issue
- 6_suppl
- Pages
- 578-578
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2791442381
- Cited by
- 199
- References
- 0
- Type
- conference abstract
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: IMmotion151: A Randomized Phase III Study of Atezolizumab Plus Bevacizumab vs Sunitinib in Untreated Metastatic Renal Cell Carcinoma (mRCC). https://app.cochat.ai/papers/10.1200/jco.2018.36.6_suppl.578
- The paper
- Motzer, R. J., Powles, T., Atkins, M. B., Escudier, B., McDermott, D. F., Suarez, C., Bracarda, S., Stadler, W. M., Donskov, F., Lee, J.-L., Hawkins, R. E., Ravaud, A., Alekseev, B. Y., Staehler, M. D., Uemura, M., Donaldson, F., Li, S., Huseni, M. A., Schiff, C., & Rini, B. I. (2018). IMmotion151: A Randomized Phase III Study of Atezolizumab Plus Bevacizumab vs Sunitinib in Untreated Metastatic Renal Cell Carcinoma (mRCC). Journal of Clinical Oncology. https://doi.org/10.1200/jco.2018.36.6_suppl.578
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