Home > Oncology > ESMO 2022 > Genitourinary Cancer – Non-Prostate Cancer > Adjuvant atezolizumab does not improve outcomes for patients with RCC and increased risk of recurrence

Adjuvant atezolizumab does not improve outcomes for patients with RCC and increased risk of recurrence

Presented by
Dr Axel Bex, The Royal Free London NHS Foundation Trust, UK
Conference
ESMO 2022
Trial
Phase 3, IMmotion-010
Doi
https://doi.org/10.55788/56513b66
Atezolizumab as adjuvant therapy after resection for patients with renal cell cancer (RCC) who have an increased risk of recurrence did not improve clinical outcomes versus placebo, results from the phase 3 IMmotion010 trial showed.

The standard-of-care for patients with locoregional or oligometastatic RCC is radical nephrectomy with or without metastasectomy [1,2]. Adjuvant treatment with pembrolizumab significantly improved disease-free survival (DFS) compared with placebo after surgery among patients with RCC who were at high risk for recurrence [3]. The phase 3 IMmotion-010 trial (NCT03024996) evaluated the safety and efficacy of adjuvant therapy with atezolizumab for patients with RCC and increased risk of recurrence. Dr Axel Bex (The Royal Free London NHS Foundation Trust, UK) presented the results [4].

The IMmotion-010 trial enrolled 778 patients with resected intermediate to high-risk RCC (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). Participants were 1:1 randomised to atezolizumab (1,200 mg every 3 weeks for 16 cycles or 1 year) or placebo. The primary endpoint was investigator-assessed DFS; key secondary endpoints were independent review facility-assessed DFS in the intention-to-treat (ITT) population and DFS in participants with PD-L1 immune cell expression ≥1%, overall survival (OS) and safety.

Adjuvant atezolizumab did not improve DFS versus placebo: median investigator-assessed DFS was 57.2 versus 49.5 months; 2-year investigator-assessed DFS was 67% versus 65% (HR 0.93; P=0.5). Exploratory analyses showed that atezolizumab improved DFS in patients (n=34) with PD-L1 immune cell expression of≥5%: HR 0.57) and in patients (n=104) with a sarcomatoid component (HR 0.77). Atezolizumab was well tolerated and the safety results were consistent with the known safety profile of atezolizumab.

“Atezolizumab as adjuvant therapy after resection for patients with RCC who have

increased risk of recurrence did not improve clinical outcomes compared with placebo. Further studies are needed to clarify the role of immunotherapy in the adjuvant setting for RCC,” summarised Dr Bex.

  1. Ingels A, et al. Nat Rev Urol. 2022;19(17):391–
  2. Ljunberg B, et al. Eur Urol. 2022;82(4):399–410.
  3. Choueiri TK, et al. N Engl J Med. 2021;385(8):683–694.
  4. Bex A, et al. 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. Abstract LBA66, ESMO Congress 2022, 09–13 September, Paris, France.

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