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Attend this session at the
2017 ASCO Annual Meeting!


Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Saturday June 3, 8:00 AM to 11:30 AM

Location: Hall A


Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Discussion Session

Time: Saturday June 3, 3:00 PM to 4:15 PM

Location: Hall D2

Efficacy and safety of epacadostat plus pembrolizumab treatment of NSCLC: Preliminary phase I/II results of ECHO-202/KEYNOTE-037.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2017 ASCO Annual Meeting

Abstract No:
9014

Poster Board Number:
Poster Discussion Session (Board #340)

Citation:
J Clin Oncol 35, 2017 (suppl; abstr 9014)

Author(s): Tara C. Gangadhar, Bryan J. Schneider, Todd Michael Bauer, Jeffrey S. Wasser, Alexander I. Spira, Sandip P. Patel, Ani Sarkis Balmanoukian, Joshua Bauml, Emmett V. Schmidt, Yufan Zhao, Mark M. Jones, Ahmad A. Tarhini; Abramson Cancer Center, Philadelphia, PA; University of Michigan, Ann Arbor, MI; Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN; University of Connecticut Health Center, Farmington, CT; Virginia Cancer Specialists Research Institute, Fairfax, VA; University of California San Diego Moores Cancer Center, La Jolla, CA; The Angeles Clinic and Research Institute, Los Angeles, CA; Merck & Co., Inc., Kenilworth, NJ; Incyte Corporation, Wilmington, DE; University of Pittsburgh Medical Center Cancer Center Pavilion, Pittsburgh, PA

Abstract Disclosures

Abstract:

Background: ECHO-202/KEYNOTE-037 is an open-label, phase 1/2 study of epacadostat (a potent and selective oral inhibitor of the immunosuppressive enzyme indoleamine 2,3-dioxygenase 1) plus pembrolizumab (E + P) in patients (pts) with advanced tumors. We report preliminary efficacy and safety outcomes for the phase 1/2 NSCLC cohort. Methods: Adult pts with prior platinum-based therapy (tx) and no prior checkpoint inhibitor tx were eligible. Phase 1 dose-escalation tx was E (25, 50, 100, 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) tx doses were selected for phase 2 cohort expansion. Efficacy was evaluated by tumor proportion score (TPS [% viable tumor cells, PD-L1 staining]: < 50% and ≥50%) and by prior lines of tx in RECIST 1.1 evaluable pts. Safety was assessed in pts receiving ≥1 E + P dose. Results: As of 29OCT2016,43 pts (phase 1, n = 12; phase 2, n = 31) were evaluated. Median age was 65 years, 58% of pts were women, 12% were EGFR-positive, and 23% were KRAS-positive. Most pts had a history of smoking (84%), ≤2 prior lines of tx (84%), and no prior TKI tx (93%). For the 40 efficacy-evaluable pts, ORR (CR+PR) and DCR (CR+PR+SD) were 35% (14/40; 14 PR) and 60% (24/40; 10 SD), respectively. PD-L1 TPS test results were available in 28/40 efficacy-evaluable pts. ORR and DCR for pts with TPS ≥50% and ≤2 prior tx were 43% (3/7; all PR) and 57% (4/7; 1 SD), respectively; for pts with TPS < 50% and ≤2 prior tx, ORR and DCR were 35% (6/17; all PR) and 53% (9/17; 3 SD). Among the 40 efficacy-evaluable pts, 12/14 responses were ongoing (range, 1+ to 519 days) at data cutoff. PFS and biomarker analyses are ongoing. Across all 43 pts, most frequent TRAEs were fatigue (19%), arthralgia (9%), and increased AST (9%); 16% of pts had grade ≥3 TRAEs, and increased lipase (asymptomatic) was the only grade ≥3 TRAE that occurred in > 1 pt (n = 2). Two pts discontinued due to TRAEs (grade 3 increased AST, grade 2 increased ALT [n = 1]; grade 2 brain edema [n = 1]). Conclusions: E + P was generally well tolerated and associated with promising responses in pts with NSCLC. A phase 3 NSCLC study is planned. Clinical trial information: NCT02178722

 
Other Abstracts in this Sub-Category:

 

1. Efficacy, safety, and biomarker results of trastuzumab emtansine (T-DM1) in patients (pts) with previously treated HER2-overexpressing locally advanced or metastatic non-small cell lung cancer (mNSCLC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 8509 First Author: Tom Stinchcombe
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

2. Ado-trastuzumab emtansine in patients with HER2 mutant lung cancers: Results from a phase II basket trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 8510 First Author: Bob T. Li
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

3. Impact of MET inhibitors on survival among patients (pts) with MET exon 14 mutant (METdel14) non-small cell lung cancer (NSCLC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 8511 First Author: Mark M. Awad
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

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