Combo Regimens Effective for Tx of Metastatic Renal Cell Cancer
Two large trials show benefits for pembrolizumab-axitinib and avelumab-axitinib versus sunitinib
WEDNESDAY, Feb. 20, 2019 (Pharmacist's Briefing) -- For first-line therapy of metastatic renal cell carcinoma, pembrolizumab plus axitinib and avelumab plus axitinib both show improved survival versus sunitinib, according to two studies published online Feb. 16 in the New England Journal of Medicine to coincide with the American Society of Clinical Oncology annual Genitourinary Cancers Symposium, held from Feb. 14 to 16 in San Francisco.
Brian I. Rini, M.D., from the Cleveland Clinic Taussig Cancer Institute, and colleagues conducted an open-label phase 3 trial involving 861 patients with previously untreated advanced clear-cell renal cell carcinoma. Patients were randomly assigned to either pembrolizumab plus axitinib (432 patients) or sunitinib (429 patients). The researchers found that the estimated percentage of patients who were alive at 12 months was 89.9 and 78.3 percent in the pembrolizumab-axitinib and sunitinib groups, respectively, after a median follow-up of 12.8 months (hazard ratio for death, 0.53). Median progression-free survival was 15.1 and 11.1 months, respectively (hazard ratio for progression or death, 0.69).
Robert J. Motzer, M.D., from Memorial Sloan Kettering Cancer Center in New York City, and colleagues randomly assigned previously untreated patients with advanced renal cell carcinoma to receive either avelumab plus axitinib (442 patients) or sunitinib (444 patients). The researchers found that median progression-free survival was 13.8 months with avelumab plus axitinib versus 7.2 months with sunitinib among the 560 patients with programmed death ligand 1-positive tumors (hazard ratio for disease progression or death, 0.61). Median progression-free survival was 13.8 and 8.4 months, respectively, in the overall population (hazard ratio, 0.69).
"These two trials had positive outcomes and showed superiority over sunitinib in terms of progression-free survival and the objective response rate," write the authors of an accompanying editorial. "Both combinations are expected to become new standards of care."
The Rini study was funded by Merck; axitinib and sunitinib were provided by Pfizer. The Motzer study was supported by Pfizer and an alliance between Pfizer and Merck.