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Adjuvant Atezolizumab in Patients with Sarcomatoid Renal Cell Carcinoma: A Prespecified Subgroup Analysis of
Jose Antonio Karam1, Robert Uzzo2, Axel Bex3
1Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Abstract:
Patients with sarcomatoid renal cell carcinoma (sRCC) have a poor prognosis. In the randomised, double-blind phase 3 IMmotion010 trial (NCT03024996), adjuvant atezolizumab did not demonstrate a disease-free survival (DFS) benefit versus placebo in the overall population of patients with locoregional renal cell carcinoma with an increased risk of recurrence following surgery. This prespecified subgroup analysis of efficacy and safety was completed in 104 patients with sRCC. Baseline characteristics were similar between treatment arms. At a median follow-up of 45 mo, the median DFS was not evaluable (NE; 95% confidence interval [CI], 12 mo-NE) in the atezolizumab arm (n = 37) and 23 mo (95% CI, 11-NE) in the placebo arm (n = 66; hazard ratio 0.77 [95% CI, 0.44-1.4]). In the sRCC subgroup, grade 3/4 treatment-related adverse events (TRAEs) occurred in one patient (2.7%) in the atezolizumab arm and two patients (3.0%) in the placebo arm. By comparison, 54 of 353 patients (15%) and 16 of 317 patients (5.0%) with non-sarcomatoid histology reported grade 3/4 TRAEs in the respective arms. In conclusion, the difference in DFS was not statistically significant between adjuvant atezolizumab and placebo in patients with sRCC. The safety profile was similar between patients with sRCC and non-sRCC. PATIENT SUMMARY: Patients with a specific type of locoregional kidney cancer (tumours with sarcomatoid features) were treated with atezolizumab or placebo after surgery. Slightly more patients treated with atezolizumab lived longer without the disease getting worse than those treated with placebo, although this finding was not statistically significant. The side effects were similar to those seen in patients with other types of kidney cancer treated with atezolizumab in the same study (IMmotion010). In patients with sarcomatoid kidney cancer, atezolizumab was tolerable and may be more effective than placebo, but this requires further study.
Insights
Adjuvant atezolizumab did not significantly improve disease-free survival for sarcomatoid renal cell carcinoma (sRCC) patients in the IMmotion010 trial. Safety profiles were comparable between atezolizumab and placebo groups, with similar side effects to non-sRCC patients.
Area of Science:
- Oncology
- Clinical Trials
- Renal Cell Carcinoma Research
Background:
- Sarcomatoid renal cell carcinoma (sRCC) presents a poor prognosis.
- The IMmotion010 trial investigated adjuvant atezolizumab in locoregional renal cell carcinoma.
- Previous results showed no overall disease-free survival (DFS) benefit in the general population.
Purpose of the Study:
- To analyze the efficacy and safety of adjuvant atezolizumab in a specific subgroup of patients with sRCC.
- To evaluate the impact of atezolizumab on disease-free survival (DFS) in patients with sarcomatoid features.
- To assess the safety profile of atezolizumab in the sRCC population compared to placebo.
Main Methods:
- A prespecified subgroup analysis of the phase 3 IMmotion010 trial.
- Inclusion of 104 patients diagnosed with sarcomatoid renal cell carcinoma (sRCC).
- Comparison of disease-free survival (DFS) and treatment-related adverse events (TRAEs) between atezolizumab and placebo arms.
Main Results:
- Median DFS was not evaluable in the atezolizumab arm versus 23 months in the placebo arm (HR 0.77).
- Grade 3/4 TRAEs occurred in 2.7% of atezolizumab-treated sRCC patients versus 3.0% in the placebo group.
- Safety profile in sRCC patients was similar to those with non-sarcomatoid histology.
Conclusions:
- Adjuvant atezolizumab did not show a statistically significant difference in DFS compared to placebo for patients with sRCC.
- Atezolizumab demonstrated tolerability in sRCC patients.
- Further investigation is warranted to confirm potential efficacy benefits of atezolizumab in this subgroup.
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