As a reminder, ASCENT was an international, multicentre, open-label, randomised phase 3 clinical trial, which evaluated Trodelvy® (n=235) vs treatment of single-agent chemotherapy of physician's choice (eribulin, vinorelbine, gemcitabine or capecitabine) (n=233) in patients with mTNBC.1
Please note that this is a post-hoc subgroup analysis from the ASCENT trial. This analysis is not powered and statistical significance cannot be inferred.
Trodelvy® improved outcomes versus all SACs used in the ASCENT trial*2
*Assessed in the BMNeg population
BMNeg, without known brain metastases; CI, confidence interval; CBR, clinical benefit rate; DOR, duration of response; n, number of participants; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; SAC, single-agent chemotherapy
Trodelvy® improved OS vs capecitabine2
Figure adapted from O'Shaughnessy J, et al. ASCO 20212
CL, confidence interval; OS, overall survival.
Trodelvy® improved OS vs eribulin2
Figure adapted from O'Shaughnessy J, et al. ASCO 20212
CL, confidence interval; OS, overall survival.
Trodelvy® improved OS vs gemcitabine2
Figure adapted from O'Shaughnessy J, et al. ASCO 20212
CL, confidence interval; OS, overall survival.
Trodelvy® improved OS vs vinorelbine2
The TNBC classification includes HER2 IHC 0 and 1+/2+ and ISH-
Adapted from Marchio C, et al. 2021, and Schnettini F, et al. 2021 5,6
Please note that this is a post-hoc subgroup analysis from the ASCENT trial. This analysis is not powered and statistical significance cannot be inferred.
Median PFS was longer with Trodelvy® than SAC across HER2 IHC scores*7
HER2 ICH0 (4.3 vs 1.6 months).7
HER2 IHC 1+/2+ & ISH- (6.2 vs 2.9 months).7
Figures adapted from Hurvitz SA, et al. ESMO, 20227
Hash marks indicate censoring. In patients with and without brain metastases.
Median OS was longer with Trodelvy® than SAC across HER2 IHC scores7
HER2 IHC0 (11.3 vs 5.9 months).7
HER2 IHC 1+/2+ & ISH- (14.0 vs 8.7 months).7
Figures adapted from Hurvitz SA, et al. ESMO, 20227
Hash marks indicate censoring. In patients with and without brain metastases: HER2 IHC 1+/2+ and ISH- defined as IHC1+, or IHC2+ and ISH-negative.
In the subgroup analysis of the ASCENT trial, clinical benefit of Trodelvy in mTNBC across Single Agent Chemotherapies and HER2 IHC scores was found to be consistent with that of the ASCENT ITT and BMNeg populations.
Consider Trodelvy® for your patients with unresectable locally advanced or mTNBC, irrespective of HER2 status, who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.7,8
Abbrevitations:
BICR, blinded independent central review; BMNeg, brain metastases-negative; CBR, clinical benefit rate; CI, confidence interval; DOR, duration of response; ECOG PS, Easter Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ICH0, immunohistochemistry 0; IHC, immunohistochemistry; ISH, in-situ hybridization; ITT, intention to treat; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; SAC, Sacituzumab; SG, Sacituzumab govitecan; TNBC, triple-negative breast cancer; TPC, treatment of physician’s choice.
References:
Bardia A, et al. N Engl J Med. 2021;384(16):1529-1541.
O’Shaughnessy J et al. Poster (1077). ASCO (virtual meeting) 2021
Breast Cancer Now. Triple Negative Breast Cancer. Available at: https://breastcancernow.org/information-support/facing-breast-cancer/diagnosed-breast-cancer/primarybreast-cancer/triple-negative-breast-cancer Accessed: April 2024.
Shirman Y.; Breast Cancer. 2023 Aug 14;15:605-619. doi: 10.2147/BCTT.S366122.
Schettini F, et al. NPJ Breast Cancer 2021;7(1):1.
Marchio, C, et al. Semin Cancer Biol 2021, 72:123-135.
Hurvitz SA, et al. Poster(168P) ESMO 2022.
Trodelvy® Summary of Product Characteristics. Gilead Sciences Ltd. Available at: https://www.medicines.org.uk/emc/product/12880. Accessed: April 2024.
UK-TRO-1609 May 2024
Adverse events should be reported
For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Gilead to [email protected] or +44 (0) 1223 897500.
