Robert J. Motzer, MD, on Outcomes of the Phase 3 CheckMate 9ER Trial in Advanced RCC

According to results of a subgroup analysis from the phase 3 CheckMate 9ER trial (NCT03141177) presented at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium, combination treatment with nivolumab and cabozantinib demonstrated improved efficacy and prolonged survival when compared with sunitinib (Sutent) among patients with previously treated advanced renal cell carcinoma (aRCC), regardless of sarcomatoid status.

In this open-label trial, adults with confirmed aRCC with a clear cell component, including those with sarcomatoid features (sRCC), were randomized 1:1 to receive either nivolumab plus cabozantinib or sunitinib. The primary end point was RECIST v1.1-defined progression-free survival by blinded independent central review (BICR) in all randomized patients. Key secondary end points included overall survival, objective response rate by BICR, and safety.

Overall, 75 patients (11.5%) had sRCC and 557 (85.6%) did not; sRCC status was not reported in 19 patients (2.9%). In total, 34 patients with sRCC received nivolumab and cabozantinib and 41 received sunitinib.

In an interview with CancerNetwork®, Robert J. Motzer, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, explained the results of the sarcomatoid subgroup analysis with regard to the overall study population.

Transcription:

What we find is that for the most part, the outcomes for the [immuno-oncologic; IO] therapy plus the [a tyrosine kinase inhibitor] are similar [in all treated patients]. It may be a bit inferior with sarcomatoid features compared to [non-sarcomatoid RCC], but it’s really the difference that we see when we compare it with the sunitinib group. Because the sarcomatoid-feature tumors are very resistant to sunitinib, we see that that resistance is released, or it’s overcome, by the IO therapy. So, it’s really more relative to how they did before.

I think it’s very clear that [for] patients who have tumors that contain these sarcomatoid features, a requirement of their therapy is one of these [immuno-oncologic] checkpoint inhibitors in combination [with a VEGF inhibitor].

Reference:

Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. J Clin Oncol. 2021;39(suppl 6):308. doi: 10.1200/JCO.2021.39.6_suppl.308