While studies have demonstrated survival benefits of first-line regimens including immuno-oncology agents ( IO ) in advanced renal cell carcinoma ( aRCC ), optimal treatment following onco-immunotherapy is unknown.
In the phase 3 METEOR trial, Cabozantinib ( Cabometyx ) improved progression-free survival ( PFS ), objective response rate ( ORR ), and overall survival ( OS ) versus Everolimus ( Afinitor ) in patients with aRCC, after VEGFR-TKI therapy.
The Japanese phase II C2001 study, targeting a population similar to that of METEOR, showed similar efficacy and safety results.
Researchers have presented a post-hoc pooled analysis of patients who had received prior onco-immunotherapy from METEOR and C2001.
A pooled analysis was performed in patients who received 60 mg/day of oral Cabozantinib once daily enrolled in the METEOR or C2001.
Patients were divided into two groups with previous IO treatment ( pre-w/ IO subgroup ) or without previous IO treatment ( pre-w/o IO subgroup ).
Analyses of overall response rate ( ORR ), progression-free survival ( PFS ), overall survival ( OS ), and safety were performed as measures of clinical outcome in each subgroup.
365 patients ( pre-w/ IO subgroup: 33 pts, pre-w/o IO subgroup:332 pts ) were included for efficacy analysis and 366 patients ( pre-w/ IO subgroup: 33 pts, pre-w/o IO subgroup:333 pts ) for safety analysis.
Minor differences in baseline characteristics were noted between the analysis subgroups but are not expected to substantially affect efficacy outcomes.
The ORR was 21.2% ( 95% CI: 9.0-38.9% ) for pre-w/ IO subgroup, and 17.2% ( 95% CI: 13.3-21.7% ) for pre-w/o IO subgroup.
PFS rate and OS rate at 6 months pre-w/ IO was 65.5%, 90.8% and pre-w/o IO was 58.3%, 90.6%, respectively.
Although there were some differences in the safety profile, almost all adverse effects were manageable by dose modifications.
There were no differences in adverse effects associated with IO treatment, such as pneumonitis, endocrinolopathy or infusion related reaction.
No new safety signals were noted in any subgroups.
In conclusion, safety and treatment efficacy of Cabozantinib were maintained in the pooled analysis of patients from METEOR and C2001 irrespective of prior IO treatment. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020