Dr Bilusic on the Non-ccRCC Treatment Armamentarium

Marijo Bilusic, MD, PhD, GU site disease group lead, GU SDD medical oncology lead, University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, discusses combination regimens under investigation for patients with non–clear cell renal cell carcinoma (ccRCC).

The continued enrollment of patients with non-ccRCC onto clinical trials is important for the expansion of the treatment armamentarium in this disease setting, Bilusic says. During an OncLive^® State of the Science Summit™ on prostate cancer and RCC, which Bilusic chaired, Jaime R. Merchán, MD, of Sylvester Comprehensive Cancer Center, presented a case discussion about the use of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in patients with non-ccRCC. Merchán noted that a subset of patients with non–clear cell disease benefit from this regimen. The single-arm, phase 2 KEYNOTE-B61 trial (NCT04704219) evaluated lenvatinib plus pembrolizumab in patients with advanced non-ccRCC and demonstrated that the overall response rate (ORR) was 49% (95% CI, 41%-57%) at a median follow-up of 14.9 months (interquartile range, 11.1-17.4). This included a 6% confirmed complete response rate and a 44% confirmed partial response (PR) rate.

Although these data are encouraging, further research in this area is always necessary, Bilusic emphasizes. Treatment regimens including cabozantinib (Cabometyx), lenvatinib, and pembrolizumab are all under investigation for patients with non-ccRCC. For instance, a phase 2 trial (NCT03635892) evaluated cabozantinib in combination with nivolumab in patients with metastatic non-ccRCC. In the population of patients with papillary, translocation, or unclassified disease histologies, at a median follow-up of 34 months (range, 20-51), the combination elicited a 48% ORR (95% CI, 31.5%-63.9%), and the median progression-free survival (PFS) was 13 months (95% CI, 7-16).

Furthermore, the phase 1b COSMIC-021 trial (NCT03170960) evaluated cabozantinib plus atezolizumab (Tecentriq) in patients with advanced non-ccRCC. At a median follow-up of 37.2 months (range, 32.1-58.5), the combination elicited a 31% ORR, all of which were PRs. The median PFS was 9.3 months (95% CI, 5.5-12.3). However, there have been no recent practice-changing additions to the non-ccRCC treatment arsenal, Bilusic concludes.