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

2022 European Society for Medical Oncology: Meeting highlights

“…IMmotion-010, a double-blind, randomized, placebocontrolled trial, examined adjuvant atezolizumab treatment in clear cell RCC (ccRCC) or RCC with a sarcomatoid component. 40 This population was similar, though not entirely identical, to the KEYNOTE-564 trial with adjuvant PEMBRO, which demonstrated a DFS benefit. 41 The primary endpoint of IMmotion-010 was DFS in the ITT population.…”

The Continuing Question of Adjuvant Therapy in Clear Cell Renal Cell Carcinoma

“…Atezolizumab is an anti-PD-L1 monoclonal antibody and has been studied in the adjuvant and metastatic settings in multiple solid tumors, including RCC. The IMmotion010 international phase III trial compared adjuvant atezolizumab vs. placebo in intermediate or high-risk patients (T2 FG 4, T3 FG 3 or 4, >T3b FG any, Tany N+ and M1 NED) with a clear cell component or sarcomatoid histology after CRN [ 7 ]. In contrast to KEYNOTE-564, IMmotion010 enrolled a different M1 population that included both synchronous metastasectomy and metachronous metastasectomy occurring over 12 months.…”

“…AEs led to treatment discontinuation in 12% of patients in the atezolizumab group and 3% in the placebo group. irAEs were reported in 54% and 28% of patients receiving atezolizumab and placebo, respectively [ 7 ]. The most common irAEs that happened in 15% of patients receiving atezolizumab were rash and hypothyroidism.…”

“…Adjuvant treatment using a mammalian target of a rapamycin (mTOR) inhibitor, everolimus, demonstrated a numerical improvement in recurrence-free survival (RFS) in patients with RCC after CRN, but it failed to meet the pre-specified statistical threshold for significance [ 6 ]. The role of immune checkpoint inhibitors (ICIs) is evolving; therapy with adjuvant pembrolizumab showed an improvement in DFS and a trend toward OS, while trials of other ICIs have thus far been disappointing [ 7 , 8 , 9 , 10 ].…”

Is Adjuvant Immunotherapy Worth for All Patients with Clear-cell Renal Cell Carcinoma at High Risk of Recurrence?

“…In summary, despite the positive findings from the KEYNOTE-564 trial [1] , [2] , several unmet clinical needs remain. Furthermore, results from other three adjuvant immune checkpoint inhibitor trials (IMmotion010 [14] , PROSPER [15] , and CheckMate-914 [16] ) have recently been reported. Unfortunately, none of these trials met their primary endpoint (improvement in DFS in comparison to placebo or observation), calling again into question the benefits of adjuvant therapy in the field of RCC.…”