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Attend this session at the
2019 ASCO Annual Meeting!


Session: Genitourinary (Nonprostate) Cancer

Type: Poster Session

Time: Monday June 3, 1:15 PM to 4:15 PM

Location: Hall A


Session: Genitourinary (Nonprostate) Cancer

Type: Poster Discussion Session

Time: Monday June 3, 4:30 PM to 6:00 PM

Location: Hall D2

Safety and efficacy of nivolumab plus ipilimumab (NIVO+IPI) in patients with advanced renal cell carcinoma (aRCC) with brain metastases: Interim analysis of CheckMate 920.

Sub-category:
Kidney Cancer

Category:
Genitourinary (Nonprostate) Cancer

Meeting:
2019 ASCO Annual Meeting

Abstract No:
4517

Poster Board Number:
Poster Discussion Session (Board #343)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 4517)

Author(s): Hamid Emamekhoo, Mark Olsen, Bradley Curtis Carthon, Alexandra Drakaki, Ivor John Percent, Ana M. Molina, Daniel C. Cho, Johanna C. Bendell, Lucio N. Gordan, Arash Rezazadeh Kalebasty, Daniel J. George, Thomas E. Hutson, Richard J. Lee, Tina C. Young, Jennifer Johansen, Scott S. Tykodi; University of Wisconsin School of Medicine and Public Health, Madison, WI; Oklahoma Cancer Specialists and Research Institute, Tulsa, OK; Emory University Winship Cancer Institute, Atlanta, GA; University of California, Los Angeles, Los Angeles, CA; Florida Cancer Specialists South/Sarah Cannon Research Institute, Port Charlotte, FL; Weill Cornell Medicine, New York, NY; New York University Langone Hospitals, New York, NY; Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Florida Cancer Specialists North/Sarah Cannon Research Institute, Gainesville, FL; Norton Cancer Institute, Louisville, KY; Duke University Medical Center, Durham, NC; Texas A&M College of Medicine, Bryan, TX; Bristol-Myers Squibb, Princeton, NJ; University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA

Abstract Disclosures

Abstract:

Background: Previous clinical trials of patients (pts) with aRCC, including CheckMate 214, have mostly excluded pts with brain metastases. However, antitumor activity in pts with brain metastases has been observed in pts with melanoma treated with NIVO 1 mg/kg + IPI 3mg/kg and pts with non-small cell lung cancer treated with NIVO 240 mg + IPI 1mg/kg. CheckMate 920 is an ongoing, phase 3b/4 clinical trial of NIVO + IPI treatment in pts with aRCC with a high unmet medical need. Here, we present the safety and efficacy interim results for the cohort of pts with brain metastases. Methods: Pts with previously untreated aRCC of any histology, with asymptomatic brain metastases (not on corticosteroids or receiving radiation), and Karnofsky performance status ≥70% were assigned to treatment with NIVO 3 mg/kg + IPI 1 mg/kg every 3 weeks for 4 doses, followed by NIVO 480 mg every 4 weeks. Pts were treated until disease progression, unacceptable toxicity, or for a maximum of 2 years. The primary endpoint was the incidence of high-grade immune-mediated adverse events (IMAEs). Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 per investigator. Exploratory endpoints included additional safety analyses and overall survival (OS). Results: Overall, 28 patients were enrolled in the brain metastases cohort. With a minimum follow-up of 6.47 months, grade 3-4 IMAEs within 100 days of last dose were reported in 6 cases. The grade 3-4 IMAEs observed in ≥ 1 patient were diarrhea, colitis, diabetic ketoacidosis, immune-mediated hepatitis, hypophysitis, and rash of any type (n = 1 each). No treatment-related grade 5 IMAEs were reported. ORR by RECIST v1.1 per investigator in all treated subjects was 28.6% (95% CI 13.2–48.7). Median PFS in all treated subjects was 9.0 months (95% CI 2.9–not estimable [NE]). Median OS has not been reached (95% CI 13.1–NE). Conclusions: In pts with aRCC and brain metastases who are often excluded from clinical trials, NIVO + IPI treatment showed a safety profile consistent with previous reports of this dosing regimen, with encouraging antitumor activity. Clinical trial information: NCT02982954

 
Other Abstracts in this Sub-Category:

 

1. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC): Outcomes in the combined IMDC intermediate/poor risk and sarcomatoid subgroups of the phase 3 KEYNOTE-426 study.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4500 First Author: Brian I. Rini
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer

 

2. A pilot randomized study evaluating nivolumab (nivo) or nivo + bevacizumab (bev) or nivo + ipilimumab (ipi) in patients with metastatic renal cell carcinoma (MRCC) eligible for cytoreductive nephrectomy, metastasectomy or post-treatment biopsy (Bx).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4501 First Author: Jianjun Gao
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer

 

3. Randomized, double-blind phase III study of pazopanib versus placebo in patients with metastatic renal cell carcinoma who have no evidence of disease following metastasectomy: A trial of the ECOG-ACRIN cancer research group (E2810).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4502 First Author: Leonard Joseph Appleman
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer

 

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