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2017 ASCO Annual Meeting!

Session: Breast Cancer—Metastatic

Type: Oral Abstract Session

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

Location: Hall D1

Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.


Breast Cancer—Metastatic

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 1008)

Author(s): Sylvia Adams, Peter Schmid, Hope S. Rugo, Eric P. Winer, Delphine Loirat, Ahmad Awada, David W. Cescon, Hiroji Iwata, Mario Campone, Rita Nanda, Rina Hui, Giuseppe Curigliano, Deborah Toppmeyer, Joyce O'Shaughnessy, Sherene Loi, Shani Paluch-Shimon, Deborah Card, Jing Zhao, Vassiliki Karantza, Javier Cortes; Perlmutter Cancer Center, New York University School of Medicine, New York, NY; Barts Health NHS Trust, London, United Kingdom; University of California San Francisco Comprehensive Cancer Center, San Francisco, CA; Dana-Farber Cancer Institute, Boston, MA; Institut Curie, Paris, France; Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Princess Margaret Cancer Centre, Toronto, ON, Canada; Aichi Cancer Center Hospital, Nagoya, Japan; Institut de Cancérologie de l'Ouest - René Gauducheau, Saint-Herblain, France; The University of Chicago, Chicago, IL; Westmead Hospital, Westmead, Australia; Instituto Europeo di Oncologia, Milano, Italy; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Baylor University Medical Center, Dallas, TX; Peter MacCallum Cancer Centre, Melbourne, Australia; Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel; Merck & Co., Inc., Kenilworth, NJ; Vall d’Hebron University Hospital Institute of Oncology (VHIO) and Ramon y Cajal University Hospital, Madrid, Spain

Abstract Disclosures


Background: In KEYNOTE-012, pembro showed durable activity and manageable safety in patients (pts) with PD-L1+ mTNBC. Cohort A of KEYNOTE-086 (NCT02447003) examined the efficacy/safety of pembro in previously treated mTNBC, regardless of PD-L1 expression. Methods: Pts with centrally confirmed mTNBC, ≥1 prior chemotherapy for metastatic disease, and ECOG PS 0-1 had pembro 200 mg Q3W for up to 24 mo; imaging q 9 wk for the first 12 mo, then q 12 wk. Clinically stable pts with PD could remain on pembro until PD confirmed on next assessment. Primary endpoints: ORR (RECIST v1.1, central review) in all pts and pts with PD-L1+ tumors, and safety. Secondary endpoints: DOR, disease control rate (DCR; CR + PR + SD ≥24 wk), PFS, and OS. Planned enrollment was 160 pts; analysis based on data as of Nov 10, 2016. Results: 60% of screened PD-L1-evaluable pts had PD-L1+ tumors (combined positive score ≥1%). Of 170 pts enrolled (100% women; median age 54 y), 44% had ≥3 prior lines of therapy, 51% had elevated LDH, 74% had visceral mets and 62% had PD-L1+ tumors. After a median follow-up of 10.9 mo, 9 (5%) pts remained on pembro. Treatment-related AEs (TRAEs) of any grade and grade 3-4 occurred in 60% and 12% of pts, respectively; 4% discontinued due to TRAEs. There were no deaths due to AE. Overall ORR was 5% regardless of PD-L1 expression (Table). Best overall response was 0.6% CR, 4% PR, 21% SD; not evaluable (3%). DCR was 8% (95% CI 4-13). Median DOR was 6.3 mo (range 1.2+ to 10.3+); 5 (63%) responders w/o PD at data cutoff. Median PFS and OS were 2.0 mo (95% CI 1.9-2.0) and 8.9 mo (95% CI 7.2-11.2), with 6-mo rates of 12% and 69%, respectively. ORR was numerically lower in pts with poor prognostic factors (e.g., high LDH, liver/visceral mets; Table). Conclusions: In KEYNOTE-086 Cohort A, pembro monotherapy showed manageable safety and durable responses in a subset of pts with heavily pretreated mTNBC. Randomized studies of monotherapy and combination therapy are ongoing. Clinical trial information: NCT02447003

ORR, % (95% CI)
Overall5 (2-9)
PD-L1, + / –5 (2-11) / 5 (1-13)
ECOG PS, 0 / 14 (1-11) / 5 (2-13)
Prior therapy, 2&3L / 4L+5 (2-12) / 4 (1-12)
LDH, ≤ULN / >ULN7 (3-15) / 2 (0.1-9)
Liver mets, no / yes7 (3-12) / 0 (0-NR)
Visceral mets, no / yes11 (5-24) / 2 (0.5-7)

Other Abstracts in this Sub-Category:


1. Association of a four-gene decision tree signature with response to platinum-based chemotherapy in patients with triple negative breast cancer.

Meeting: 2017 ASCO Annual Meeting Abstract No: 1006 First Author: Jelmar Quist
Category: Breast Cancer—Metastatic - Triple-Negative


2. Final results of a phase 2 study of talazoparib (TALA) following platinum or multiple cytotoxic regimens in advanced breast cancer patients (pts) with germline BRCA1/2 mutations (ABRAZO).

Meeting: 2017 ASCO Annual Meeting Abstract No: 1007 First Author: Nicholas C. Turner
Category: Breast Cancer—Metastatic - Triple-Negative


3. LOTUS (NCT02162719): A double-blind placebo (PBO)-controlled randomized phase II trial of first-line ipatasertib (IPAT) + paclitaxel (P) for metastatic triple-negative breast cancer (TNBC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 1009 First Author: Rebecca Alexandra Dent
Category: Breast Cancer—Metastatic - Triple-Negative