Treatment with a dual regimen of avelumab and axitinib was associated with superior progression-free survival (PFS) and objective response compared with sunitinib monotherapy in patients with advanced renal cell carcinoma (RCC), according to study findings presented at the 2019 Genitourinary Cancers Symposium.1
“The results do support avelumab plus axitinib as a new first-line standard of care for patients with advanced RCC,” co-lead investigator Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, told meeting attendees. Dr Choueiri’s presentation coincides with publication of the study findings in the New England Journal of Medicine.2
He and his team observed these advantages in patients across all prognostic risk groups and PD-L1 subgroups.
The findings are from a subgroup analysis of patients with previously untreated advanced RCC in the ongoing JAVELIN Renal 101 trial, which previously demonstrated longer PFS (median 13.8 vs 8.4 months) and objective response rate (ORR, 51% vs 26%) with avelumab plus axitinib compared with sunitinib. Of 886 patients who were randomly selected, 560 (63%) had PD-L1–positive tumors. At data cut-off in June 2018, the median follow-up time was 12 months for the combination therapy arm and 11.5 months for the sunitinib arm.
Dr Choueiri’s team compared the effects of the treatment approach according to Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups (favorable-, intermediate-, and poor-risk). Among patients with MSKCC favorable-risk disease, the median PFS, in months, was not estimable (NE) (95% CI, 12.6-NE) and the ORR was 66% in the avelumab-axitinib group (95% CI, 55.2%-75.0%), whereas the median PFS and ORR were 16.7 months (95% CI, 11.1%-18.6%) and 38% (95% CI, 28.5%-48.3%), respectively, in the sunitinib arm.
For patients with MSKCC intermediate-risk disease, the median PFS was 13.3 months (95% CI, 8.5-NE) and the ORR was 50% (95% CI, 43.5%-55.5%) in the combination arm compared with 7.9 months (95% CI, 6.7-9.8) and 24% (95% CI, 19.4%-29.6%) in the sunitinib-treated patients.
In the MSKCC poor-risk patient cohort, the median PFS and ORR were 5.6 months (95% CI, 2.6-11.2) and 31% (95% CI, 19.1%-45.9%), respectively, for those treated with the dual regimen and 2.8 months (95% CI, 1.5-2.9) and 9% (95% CI, 2.5%-21.2%), respectively, for those in the sunitinib cohort. The findings across the IMDC risk groups were similar.
For patients with PD-L1–positive tumors, the median PFS and ORR were 13.8 months (95% CI, 11.1-NE) and 55% (95% CI, 49.0%-61.2%), respectively, in the avelumab-axitinib group, compared with 7.2 months (95% CI, 5.7-9.7) and 26% (95% CI 20.6%-30.9%), respectively, in the sunitinib arm. Among patients with PD-L1–negative tumors, the median PFS and ORR were 16.1 months (95% CI, 9.7-NE) and 47% (95% CI, 38.2%-55.8%), respectively, for recipients of the combination therapy, compared with 11.1 months (95% CI, 6.9-17.3) and 28% (95% CI, 20.5%-37.3%), respectively, for the sunitinib group.
Disclosure: The trial is sponsored by Pfizer, Inc., and an alliance between Pfizer and Merck (Darmstadt, Germany). For a full list of disclosures, please see the original studies.
- Choueiri TK, Motzer RJ, Campbell MT, et al. Subgroup analysis from JAVELIN Renal 101: Outcomes for avelumab plus axitinib (A + Ax) versus sunitinib (S) in advanced renal cell carcinoma (aRCC). Data presented at: the 2019 Genitourinary Cancers Symposium; San Francisco, CA; February 14-16, 2019. Abstract 544.
- Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma [published online February 16, 2019]. N Engl J Med. doi: 10.1056/NEJMoa1816047