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2019 ASCO Annual Meeting!

Session: Genitourinary (Nonprostate) Cancer

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Arie Crown Theater

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).

Kidney Cancer

Genitourinary (Nonprostate) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 4501)

Author(s): Jianjun Gao, Jose A. Karam, Nizar M. Tannir, Matthew T Campbell, Rebecca Slack Tidwell, Kamran Ahrar, Priya Rao, Chaan S. Ng, Eric Jonasch, Surena F. Matin, Amado J. Zurita, Amishi Yogesh Shah, Yu Shen, Jorge M. Blando, Luis M. Vence, Sreyashi Basu, Hao Zhao, James Patrick Allison, Christopher G. Wood, Padmanee Sharma; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Texas MD Anderson Cancer Center, Houston, TX; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX

Abstract Disclosures


Background: Cytoreductive surgery (CS) including cytoreductive nephrectomy and metastasectomy provides clinical benefits to patients with MRCC. However, CS has not been evaluated in the setting of immune checkpoint (IC) therapy. We performed a pre-surgical/biopsy trial to evaluate biological and clinical activity of nivo +/- (bev or ipi) in patients with MRCC. Methods: In this open-label, randomized trial (NCT02210117), patients with MRCC w/o prior IC therapy and anti-VEGF therapy were randomized 2:3:2 to receive nivo (3mg/kg q2wks x3), nivo + bev (10mg/kg q2wks x3) or nivo + ipi (1mg/kg q3wks x2), followed by CS or Bx, and then nivo maintenance therapy up to 2 yrs. Clinical response per RECIST criteria was assessed at ≥12 wks. Pre- and post-treatment blood and tumors were obtained for correlative studies. Results: All of 105 patients have been accrued and 104 are evaluable for response. For all patients, best overall response (BOR = complete response [CR] + partial response [PR]) including surgery effect was 55% nivo, 44% nivo + bev, 43% nivo + ipi. Median PFS (95% confidence interval) was 14.5 months (5.5, not reached [NR]) nivo, 7.6 (4.8, 8.9) months nivo + bev, 7.5 (2.0, 12.4) months nivo + ipi. Overall survival (OS) at one year was 86% nivo, 73% nivo + bev, 83% nivo + ipi. Grade 3 or higher toxicities related to therapy were 38% for nivo, 42% for nivo + bev (including 18% hypertension), and 47% for nivo + ipi. For patients with CS, BOR including surgery effect was: 86% nivo, 88% nivo + bev, and 69% nivo + ipi. Median PFS was 17.3 months (6.1, NR) nivo, 7.6 (5.7, 10.3) months nivo + bev, 8.9 (2.9, 23.0) months nivo + ipi. OS at one year was 100% nivo, 94% nivo + bev, 92% nivo + ipi. Median OS has not yet reached with a median follow-up of 24.6 months. Immune and gene profiling analyses demonstrate: 1) tumor infiltrating CD8 T cells correlate with clinical responses to nivo or nivo + bev, but not to nivo + ipi; 2) tumor IFN pathway gene expression correlates with responses; and 3) PD-L1 status, tumor mutation or mutation burden, neoantigens did not correlate with response. Conclusions: IC therapy plus CS is safe and beneficial to patients with MRCC and therefore, warrants testing, along with a few correlative biomarkers, in a larger phase 3 trial. Clinical trial information: NCT 02210117.

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. 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


3. Cytoreductive nephrectomy (CN) in metastatic renal cancer (mRCC): Update on Carmena trial with focus on intermediate IMDC-risk population.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4508 First Author: Arnaud Mejean
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer