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2017 ASCO Annual Meeting!

Session: Genitourinary (Nonprostate) Cancer

Type: Poster Session

Time: Sunday June 4, 8:00 AM to 11:30 AM

Location: Hall A

Session: Genitourinary (Nonprostate) Cancer

Type: Poster Discussion Session

Time: Sunday June 4, 11:30 AM to 12:45 PM

Location: Arie Crown Theater

Epacadostat plus pembrolizumab in patients with advanced RCC: Preliminary phase I/II results from ECHO-202/KEYNOTE-037.

Kidney Cancer

Genitourinary (Nonprostate) Cancer

2017 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #193)

J Clin Oncol 35, 2017 (suppl; abstr 4515)

Author(s): Primo Lara, Todd Michael Bauer, Omid Hamid, David C. Smith, Thomas Gajewski, Tara C. Gangadhar, Bradley G. Somer, Emmett V. Schmidt, Yufan Zhao, Hema Gowda, Anthony J. Olszanski; University of California Davis Comprehensive Cancer Center, Sacramento, CA; Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN; The Angeles Clinic and Research Institute, Los Angeles, CA; University of Michigan, Ann Arbor, MI; University of Chicago Medical Center, Chicago, IL; Abramson Cancer Center, Philadelphia, PA; West Clinic PC, Memphis, TN; Merck & Co., Inc., Kenilworth, NJ; Incyte Corporation, Wilmington, DE; Fox Chase Cancer Center, Philadelphia, PA

Abstract Disclosures


Background: Epacadostat (E) is a potent oral inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1), a tryptophan-catabolizing enzyme that induces immune tolerance by T-cell suppression. Preclinical and clinical data suggest that epacadostat has antitumor activity when combined with checkpoint inhibitors, including the PD-1 inhibitor pembrolizumab (P). ECHO-202/KEYNOTE-037 is an ongoing open-label, phase 1/2 (P1/2) study evaluating E + P in multiple tumor types. We report preliminary P1/2 efficacy and safety data for the advanced renal cell carcinoma (RCC) cohort as of a 29OCT2016 data cutoff. Methods: Eligible patients (pts) had advanced clear-cell RCC, prior antiangiogenic therapy (tx), and no prior checkpoint inhibitor tx. In P1 dose escalation (3+3+3), pts received E (25, 50, 100, or 300 mg PO BID) + P (2 mg/kg or 200 mg IV Q3W); MTD was not exceeded. E (100 mg BID) + P (200 mg Q3W) dosing was selected for P2 cohort expansion. Response was assessed in RECIST 1.1 evaluable pts. Safety/tolerability was assessed in pts receiving ≥1 E + P dose. Results: 33 pts (P1, n = 11; P2, n = 22) were enrolled (median age, 63 years; 70% men; 97% white; MSKCC criteria of favorable, intermediate, and poor in 6%, 64%, and 12% of pts, respectively). Of 30 efficacy-evaluable pts, 63% (n = 19) had 0–1 prior tx and 37% (n = 11) had ≥2 prior tx for advanced disease. ORR (CR+PR) and DCR (CR+PR+SD) for pts with 0–1 prior tx was 47% (9/19; 1 CR, 8 PR) and 58% (11/19; 1 CR, 8 PR, 2 SD), respectively; for pts with ≥2 prior tx, ORR and DCR were 0% and 36% (4/11; all SD). At data cutoff, 9/9 responses were ongoing (range, 1+ to 372+ days). PFS and biomarker analyses are ongoing. TRAEs occurring in ≥10% of the 33 pts included fatigue and rash (36% each); and arthralgia, diarrhea, pruritus, and pyrexia (12% each). Grade ≥3 TRAEs occurred in 15% of pts (none in > 1 pt). Two pts discontinued due to TRAEs (grade 3 autoimmune hepatitis, n = 1; grade 3 aseptic meningitis/headache/nausea/vomiting/anxiety, n = 1). Conclusions: E + P was generally well tolerated and associated with encouraging response outcomes in advanced RCC pts with 0–1 prior line of tx. E + P represents a novel immunotherapeutic strategy. A phase 3 RCC study is planned. Clinical trial information: NCT02178722

Other Abstracts in this Sub-Category:


1. First-line avelumab + axitinib therapy in patients (pts) with advanced renal cell carcinoma (aRCC): Results from a phase Ib trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4504 First Author: Toni K. Choueiri
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer


2. IMmotion150: A phase II trial in untreated metastatic renal cell carcinoma (mRCC) patients (pts) of atezolizumab (atezo) and bevacizumab (bev) vs and following atezo or sunitinib (sun).

Meeting: 2017 ASCO Annual Meeting Abstract No: 4505 First Author: Michael B. Atkins
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer


3. A phase I/II study to assess the safety and efficacy of pazopanib (PAZ) and pembrolizumab (PEM) in patients (pts) with advanced renal cell carcinoma (aRCC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 4506 First Author: Simon Chowdhury
Category: Genitourinary (Nonprostate) Cancer - Kidney Cancer