Triple-detrimental breast cancer (TNBC) patients observed a necessary survival abet when handled with third-line sacituzumab govitecan (Trodelvy) comparatively than chemotherapy, half III findings from the ASCENT trial confirmed.
The trial met or no longer it’s vital endpoint, bettering median development-free survival (PFS) in patients without mind metastases and whose disease stepped forward on no longer no longer as a lot as 2 earlier lines of therapy, from 1.7 months with physician’s need of chemotherapy to 5.6 months with sacituzumab govitecan (HR 0.41, 95% CI 0.32-0.52, P<0.0001), reported Aditya Bardia, MD, MPH, of Harvard Scientific School in Boston.
And median general survival (OS) improved from 6.7 months with single-agent chemotherapy to 12.1 months with the antibody-drug conjugate (HR 0.48, 95% CI 0.38-0.59, P<0.0001), he stated for the length of a presentation on the 2020 European Society for Scientific Oncology (ESMO) virtual congress.
Sacituzumab govitecan additionally resulted in vastly more responses, at 35% in comparison with 5% with chemotherapy, collectively with total responses in 4% and 1%, respectively. Sufferers on sacituzumab govitecan additionally had a increased medical abet rate (response plus acquire disease), at 45% versus 9% in the protect a watch on arm. At recordsdata cutoff, 15 patients remained on sacituzumab govitecan versus none in the protect a watch on arm.
“The medical abet right here confirms the advise of sacituzumab govitecan as a customary therapy for patients with pretreated metastatic triple-detrimental breast cancer,” Bardia stated.
Sacituzumab govitecan is a monoclonal antibody directed in opposition to trophoblast cell-ground antigen (Trop)-2, which is linked to a topoisomerase inhibitor chemotherapeutic agent. Trop-2 is extremely expressed in breast cancer.
FDA no longer too lengthy previously granted accelerated approval to the agent as a third-line treatment for metastatic TNBC primarily primarily based on single-arm findings that demonstrated responses in a third of patients, with some lasting beyond 12 months. Continued approval is contingent on outcomes from confirmatory trials, similar to ASCENT.
ASCENT “is the first half III judge to expose a necessary enchancment in efficacy with a first-in-class Trop-2-directed antibody-drug conjugate in comparison with customary chemotherapy in patients with beforehand handled metastatic triple-detrimental breast cancer,” stated Bardia.
The most identical old detrimental events (AEs) of any grade included neutropenia in 63%, diarrhea in 59%, nausea in 57%, alopecia in 46%, fatigue in 45%, and anemia in 34%. General grade 3/4 AEs included neutropenia in 63%, leukopenia in 11%, diarrhea in 10%, anemia in 8%, and febrile neutropenia in 6%.
Within the investigational arm, 4.7% of patients stopped treatment attributable to AEs, while 5.4% stopped for toxicity in the chemotherapy arm. There were no treatment-linked deaths with the judge drug versus one in the chemotherapy arm (sepsis).
ASCENT randomized 529 TNBC patients at 88 sites in seven worldwide locations 1:1 to both intravenous sacituzumab govitecan (10 mg/kg on days 1 and eight every 3 weeks) or physician’s need of chemotherapy (eribulin [n=139], vinorelbine [n=52], gemcitabine [n=38], or capecitabine [n=33]), with treatment till disease development or unacceptable toxicity.
Sufferers had been required to maintain obtained no longer no longer as a lot as 2 prior chemotherapies for superior disease. Sufferers with mind metastases — a community with sorrowful prognosis — could seemingly well signal up on the trial however had been minute to 15% of the population to handbook clear of doable confounding. The general public had been girls folk (99%) with a median age 54, and 79% had been white. All had obtained prior taxane chemotherapy and a pair of third in every arm had beforehand obtained a checkpoint inhibitor.
The major endpoint was PFS in patients without mind metastases (n=468) on blinded central overview, and the implications had been fixed across all prespecified subgroups, collectively with age, dawdle, set apart, prior chemotherapy, liver involvement, and prior checkpoint inhibitor advise. Secondary endpoints included PFS of the elephantine population (HR 0.43, 95% CI 0.35-0.54, P<0.0001), as well to OS, levels of response, and security.
Ian Ingram joined MedPage Nowadays in 2018 as Deputy Managing Editor, and covers oncology for the set apart.
ASCENT was supported by Immunomedics.
Bardia disclosed linked relationships with Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Properly being, Immunomedics, InnoCan, Spectrum Pharma, Taiho, Daiichi Pharma/AstraZeneca, Puma, and Eli Lilly.