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Tecentriq–Avastin regimen extends PFS in PD-L1–positive advanced renal cell carcinoma
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The combination of atezolizumab and bevacizumab conferred no significant PFS benefit compared with sunitinib monotherapy among patients with locally advanced or metastatic renal cell carcinoma, according to an intention-to-treat analysis of a phase 2 study presented at Genitourinary Cancers Symposium.
However, atezolizumab (Tecentriq, Genentech) and bevacizumab (Avastin, Genentech) significantly extended PFS compared with sunitinib (Sutent, Pfizer) monotherapy among patients whose disease expressed PD-L1.
Atezolizumab is a PD-L1 inhibitor, bevacizumab is a humanized anti–vascular endothelial growth factor monoclonal antibody, and sunitinib is a multitargeted receptor tyrosine kinase inhibitor.
The randomized, multicenter, open-label IMmotion150 study compared three regimens in patients with treatment-naive locally advanced or metastatic renal cell carcinoma (mRCC):
- 1,200 mg atezolizumab every 3 weeks plus 15 mg bevacizumab (Avastin, Genentech) until disease progression or lack of clinical benefit (n = 101);
- 1,200 mg atezolizumab monotherapy (n = 101); and
- 50 mg sunitinib for 4 weeks, followed by 2 weeks of rest, until disease progression (n = 103).
PFS in both the intention-to-treat population and in a PD-L1–selected subgroup served as coprimary endpoints.
The atezolizumab–bevacizumab regimen conferred no significant median PFS advantage compared with sunitinib in the intention-to-treat population (11.7 months vs. 8.4 months; HR = 1; 95% CI, 0.69-1.45).
However, among the subgroup of patients whose disease expressed PD–L1 (n = 50), the atezolizumab–bevacizumab regimen conferred a 36% reduction in risk for progression compared with sunitinib alone (median PFS, 14.7 months vs. 7.8 months; HR = 0.64; 95% CI, 0.38-1.08).
Both the atezolizumab–bevacizumab combination and sunitinib monotherapy appeared superior to atezolizumab monotherapy with regard to PFS.
After 20.7 months of follow-up, median duration of response had not been reached in any treatment group.
Adverse events in the combination group appeared consistent with those reported in prior studies of the two agents.
“These phase 2 results support the scientific rationale for potentially combining atezolizumab and bevacizumab in people with this type of kidney cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “There is a significant need for new treatment options for people living with advanced RCC, a disease where currently only about one in 10 people are alive beyond 5 years following diagnosis.”
The phase 3 IMmotion151 study also is evaluating the combination of atezolizumab and bevacizumab vs. sunitinib in patients with mRCC.
An additional study designed to evaluate atezolizumab as adjuvant treatment for RCC is enrolling patients.
Atezolizumab is approved to treat:
- patients with locally advanced or metastatic urothelial carcinoma who experienced disease progression during or after platinum-based chemotherapy, or whose disease worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy; and
- patients with metastatic non–small cell lung cancer who experienced disease progression during or after platinum-containing chemotherapy, and who have progressed on an appropriate FDA–approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.