Pembrolizumab Plus Axitinib for Advanced RCC

Transcript: Daniel J. George, MD: Hello, and thank you for joining this OncLive Peer Exchange® titled “Contemporary Management of Metastatic Renal Cell Carcinoma.”

Standards of care for patients with metastatic renal cell carcinoma are pivoting once again, most recently with the approval of a VEGF [vascular endothelial growth factor] targeted TKI [tyrosine kinase inhibitor] plus immune checkpoint combination regimen. Busy oncologists, who treat patients with metastatic disease, now have even more therapeutic options to choose from when formulating a treatment plan across lines of therapy.

In this OncLive® Peer Exchange discussion, my colleagues and I will look at the challenges in finding the right systemic treatment for right patient. We’ll talk about the data from ASCO [the American Society of Clinical Oncology] 2019 Annual Meeting and how it relates to the treatment of advanced disease.

I’m Dr Daniel George, a professor of medicine and surgery at the Duke University School of Medicine and a co-lead of the DCI [Duke Cancer Institute] center for prostate and neurological cancers in Durham, North Carolina.

Participating today on our panel are:

Dr Bob Alter, a medical oncologist and hematologist at the John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, New Jersey.

Dr Chung-Han Lee, otherwise known as Joe Lee, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York, New York.

And Dr Nizar Tannir, a professor of and the chair ad interim of department of genitourinary oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas.

Thank you so much for joining us. Let’s begin.

Daniel J. George, MD: Let’s start with you, Bob. First, there were 2 studies—pivotal trials—presented at GUCS [Genitourinary Cancers Symposium] ASCO this year. The KEYNOTE-426 study and the JAVELIN Renal 101 study. Let’s start with KEYNOTE-426. Can you walk us through that study?

Robert S. Alter, MD: I’ll try. This was a clinical trial looking at patients with untreated metastatic renal cell carcinoma [RCC], predominantly clear cell. Patients were stratified according to IMDC [International Metastatic RCC Database Consortium] and geography. The primary endpoint was progression-free survival and overall survival with the intent-to-treat population, with secondary endpoints as response rate.

The details are quite extensive. We’ll sort of condense it to the endpoints that were trying to be evaluated were met with very good hazard ratios. For patients looking at the primary endpoint of overall survival, the estimated percentage of patients alive at 1 year and at 18 months were met with a hazard ratio of 0.53. For patients with a progression-free survival, their hazard ratio was 0.69, favoring the pembrolizumab and axitinib compared with the sunitinib. The median progression-free survival was 15.1 months compared with 11.1 months, and response rates were quite robust. For patients who received pembrolizumab and axitinib, their response rate was 59.3% compared with patients who received sunitinib, which is 35.7% again, with a very strong P value.

The breakdown of the response rates—patients who had a complete remission in patients with the pembrolizumab-axitinib arm was 5.8% compared with patients with sunitinib, which is 1.4%. The partial responses were around 53% to 54% in patients who received the pembrolizumab-axitinib combination, compared with sunitinib, which was around 34%. So again, their strong primary endpoints were all met. As we discussed at the meetings, we feel very confident that this will become almost a new first-line therapy in patients who were untreated with metastatic renal cell carcinoma.

Daniel J. George, MD: It’s really impressive data when you look at it. I mean, a 59% response rate, the duration of response, and the early overall survival signal.

Transcript Edited for Clarity