ASCO GU 2019: Thirty Month Follow-up of the Phase III CheckMate 214 Trial of First-line Nivolumab + Ipilimumab or Sunitinib in Patients with Advanced Renal Cell Carcinoma
Dr. Tannir then summarized the study design methodology of CheckMate 214. Patients with clear cell aRCC were randomized 1:1 to Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W×4 and then N3 mg/kg Q2W, or S 50 mg daily for 4 weeks on, 2 weeks off. Co-primary endpoints were overall survival (OS), RECISTv1.1 objective response rates (ORR) and progression-free survival (PFS) per independent radiographic review committee (IRRC) in I/P patients. For this extended follow-up, PFS and ORR were assessed by the investigator at 30 months.
Dr. Tannir then highlighted the updated results at 30 months minimum follow-up. Baseline characteristics were matched between the groups. OS remained significantly improved in ITT and I/P patients with N+I versus S; the HR for OS in favorable risk patients improved for N+I versus the previous analysis (1.22 [95% CI 0.73–2.04] vs. 1.45 [99.8% CI 0.51‒4.12]). Per previous IRRC ORR (N+I, 42% [95% CI 37‒47]; S, 27% [95% CI 22‒31]), ORR per investigator was higher with N+I versus S in ITT and I/P patients. ORR CIs overlapped in favorable patients, CR was doubled with N+I versus S. Increasing PFS benefit with N+I versus S is emerging in ITT and I/P patients; PFS CIs between arms remain overlapping in favorable patients. 15% versus 9% of N+I and S ITT pts remain on therapy, and 48% versus 61% have received 2nd-line systemic therapy; 39% of S pts received subsequent immune-checkpoint inhibitor therapy. Among pts who were alive with CR, 50% versus 10% remain on treatment with N+I (n = 56) versus S (n = 10). 5 N+I and 7 S additional pts developed Grade 3–4 drug-related adverse events; 1 N+I and 3 S additional patients had adverse events leading to discontinuation. No new drug-related deaths occurred.
He concluded his talk with a summary that at 30 months minimum follow-up, OS, PFS, and ORR remain improved with N+I versus S in ITT and I/P CheckMate 214 patients. In the small favorable-risk subgroup, no statistical difference was observed between the arms in OS, PFS, or ORR. Regardless of risk category, impressive CR rates were observed with N+I. Responses with N+I were deeper and more durable. No new safety signals emerged with longer follow-up.
Presented by: Nizar M. Tannir, MD, FACP
Written by: Abhishek Srivastava, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Fox Chase Cancer Center, Philadelphia, PA at the Annual ASCO GU meeting 2019, San Francisco, CA, Twitter: @shekabhishek at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA