Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study

By Editorial Team
Exciting results for a new first line option in PD-L1+ mTNBC (pretreated metastatic TNBC).

ASCENT-04/KEYNOTE-D19 study

Background:

Although PD-1/PD-L1* inhibitors plus chemo have expanded treatment options for previously untreated PD-L1–positive advanced TNBC, there still remains a critical unmet need to improve outcomes. SG previously demonstrated significant clinical benefit in pretreated metastatic TNBC (mTNBC). We report results from the ASCENT-04/KEYNOTE-D19 study in patients with previously untreated, PD-L1–positive (CPS ≥ 10; 22C3 assay) locally advanced unresectable or mTNBC.

Note: PD-L1 stands for programmed death ligand 1. It's a protein found on some normal cells and can be expressed on cancer cells. It acts as a brake on the immune system, preventing T cells from attacking other cells, including cancer cells. When PD-L1 binds to another protein called PD-1, it inhibits T cell activity. (National Cancer Institute)

Methods:

Patients were randomized 1:1 to SG (10 mg/kg IV, day 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro until disease progression or unacceptable toxicity. Randomization was stratified by curative treatment-free interval, geography, and prior exposure to anti–PD-(L)1 therapy in the curative setting. Primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS); objective response rate (ORR) and duration of response (DOR) by BICR; and safety.

Results:

443 patients were randomized at a 1:1 ratio: 221 to SG + pembro and 222 to chemo + pembro. The median follow-up was 14 mo. SG + pembro showed a significant improvement in PFS by BICR compared with chemo + pembro (hazard ratio [HR], 0.65; 95% CI, 0.51-0.84; P = .0009; Table). Median DOR was 16.5 mo for SG + pembro vs 9.2 mo for chemo + pembro (Table). Although OS data were immature, a positive early trend in OS improvement was also noted. The most frequent (≥ 10% of patients) grade ≥ 3 treatment-emergent adverse events (TEAEs) with SG + pembro were neutropenia (43%) and diarrhea (10%); and with chemo + pembro were neutropenia (45%), anemia (16%), and thrombocytopenia (14%).

Conclusions:

SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro with durable responses, no new safety concerns for SG or pembro, and a lower rate of treatment discontinuation due to TEAEs in patients with previously untreated, PD-L1–positive advanced TNBC. These data support the use of SG + pembro as a potential new standard of care treatment in this patient population.


Authors:
Sara M. Tolaney, Evandro de Azambuja, Kevin Kalinsky, Sherene Loi, Sung-Bae Kim, Clinton Yam, Bernardo L. Rapoport, Seock-Ah Im, Barbara Pistilli, Wassim McHayleh, David W. Cescon, Junichiro Watanabe, Alejandro Lara, Ruffo Freitas-Junior, Javier S. Bofill, Maryam Afshari, Dianna Gary, Lu Wang, Catherine Lai, Peter Schmid

Associated Organizations:
Dana-Farber Cancer Institute and Harvard Medical School,Boston,MA; Institut Jules Bordet Hôpital Universitaire de Bruxelles (H.U.B) and Université Libre de Bruxelles (ULB),Brussels,Belgium; Winship Cancer Institute at Emory University,Atlanta,GA; Peter MacCallum Cancer Centre,Melbourne,Australia; Asan Medical Center,University of Ulsan College of Medicine,Seoul,n/a,South Korea; The University of Texas MD Anderson Cancer Center,Houston,TX; The Medical Oncology Centre of Rosebank,Clinical and Translational Research Unit,Department of Immunology,Faculty of Health Sciences,University of Pretoria,Saxonworld,South Africa; Seoul National University College of Medicine,Cancer Research Institute,Seoul National University,Seoul,South Korea; Gustave Roussy,Department of Medical Oncology,IHU-National PRecISion Medicine Center in Oncology,Villejuif,France; AdventHealth Cancer Institute,Orlando,FL; Princess Margaret Cancer Centre/UHN,Toronto,ON,Canada; Juntendo University Graduate School of Medicine,Tokyo,Japan; Oncology Center of Chihuahua,Chihuahua,Mexico; CORA – Advanced Center for Diagnosis of Breast Diseases Federal University of Goias,Goiania,Goias,Brazil; Hospital Universitario Virgen del Rocío,Sevilla,Spain; Gilead Sciences,Inc.,Foster City,CA; Gilead Sciences,Inc,Foster City,CA; Gilead Sciences,Inc,Foster City,CA; Gilead Sciences,Inc,Foster City,CA; Barts Cancer Institute,London,United Kingdom

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