Gilead Oncology Trodelvy Overview | GileadPro

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Adverse Event Reporting Prescribing information

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Trodelvy®, the first approved TROP-2 directed antibody drug conjugate, has been shown to significantly improve both progression-free survival (p<0.0001) and overall survival (p<0.0001) versus single-agent chemotherapy (SAC) treatment of physician’s choice in second-line and later metastatic triple-negative breast cancer (mTNBC).1

GB: Trodelvy® is indicated for the treatment of adult patients with unresectable locally advanced or mTNBC who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.1

Introducing Trodelvy®
In patients without known brain metastases in the ASCENT trial:*2

3X LONGER
median PFS
vs single-agent chemotherapy

Median progression-free survival (PFS): 5.6 months with Trodelvy® (95% CI: 4.3–6.3) vs 1.7 months with single-agent chemotherapy (95% CI: 1.5–2.6); HR: 0.41; 95% CI: 0.32–0.52; p<0.0001†1,2

1 YEAR
median OS

Median overall survivial (OS): 12.1 months with Trodelvy® (95% CI: 10.7–14.0) vs 6.7 months with single-agent chemotherapy (95% CI: 5.8–7.7); HR: 0.48; 95% CI: 0.38–0.59; p<0.0001†1-3

SAFETY PROFILE
generally manageable

5% of patients in both arms discontinued for any adverse reaction.3 The most common adverse drug reactions (reported at a frequency of ≥20%) in the overall TNBC population from pooled data from two clinical studies (IMMU-132-01 and IMMU-132-05 [N=258; ASCENT]) were diarrhoea (64.5%), nausea (64.2%), neutropenia (64.2%), fatigue (52.5%), alopecia (44.3%), anaemia (43.4%), vomiting (38.5%), constipation (36.3%), decreased appetite (28.1%), cough (22.7%), and abdominal pain (20.5%)‡1
In health-related quality of life-evaluable patients in the ASCENT trial:*2

HRQoL
improvements clinically
meaningful vs single-agent chemotherapy

Trodelvy® was noninferior to single-agent chemotherapy on all primary health-related quality of life (HRQoL) domains and superior on global health status/quality of life, physical functioning, fatigue, and pain.§3 Trodelvy® was superior to SAC (SAC; eribulin, vinorelbine, gemcitabine, or capecitabine) for emotional functioning, dyspnoea, and insomnia and non-inferior to SAC for all other secondary domains except diarrhoea.3

*The ASCENT trial was an international, multicentre, open-label, randomised, phase 3 clinical trial that evaluated Trodelvy® as compared with treatment of single-agent chemotherapy of the physician’s choice (eribulin, vinorelbine, gemcitabine, or capecitabine) in 529 patients with second-line or later mTNBC.2

†The efficacy results in all patients (N=529) were consistent with the population without known brain metastases (median PFS: 4.8 months vs 1.7 months [HR: 0.43; 95% CI: 0.35–0.54; p<0.001]; median OS: 11.8 months vs 6.9 months [HR: 0.51; 95% CI: 0.41–0.62]).1,2

‡IMMU-132-01 (NCT01631552) was a phase 1–2, multicentre, single-arm clinical trial that enrolled 108 patients with mTNBC who had received at least two prior treatments for metastatic disease.1

§Primary HRQoL domains: Global health status/quality of life, physical functioning, role functioning, pain, and fatigue. Selected as clinically relevant in the target population and used as primary HRQoL in other published studies.3

Find out where Trodelvy® fits into treatment for adult patients progressing from earlier stage or refractory/relapsed mTNBC or diagnosed with de novo unresectable locally advanced or mTNBC.

These pathways relate to the proposed positioning of Trodelvy® with respect to its licence and are not intended as a comprehensive representation of guidelines for unresectable locally advanced or mTNBC.

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Trodelvy® is the first approved TROP-2-directed antibody-drug conjugate that selectively delivers a cytotoxic payload, SN-38, to cancer cells, including TNBC cells and the tumour microenvironment through a bystander effect.1,4

Trodelvy® is the first and only approved TROP-2-directed antibody-drug conjugate1,2

Mechanism of action

90% of TNBC tumours express TROP-25

TROP-2-directed antibody humanised monoclonal antibody1
Used to target and bind to TROP-2, a cell surface antigen highly expressed in multiple tumour types, including in TNBC tumours2,5-7

Anticancer Drug/Cytotoxic Agent (SN-38) is a potent topoisomerase I inhibitor with moderate toxicity1,8,9
High drug-to-antibody ratio of ~8:18,10

Hydrolysable Linker (CL2A) is a moderately stable, hydrolysable linker that protects SN-38 from inactivation and facilitates delivery of the active form of the drug to the cancer cells and tumour microenvironment (bystander effect)11,13
Limits the quantity of free SN-38 in the serum8

  1. Trodelvy® GB Summary of Product Characteristics. Gilead Sciences Ltd. Available at: https://www.medicines.org.uk/emc/product/12880. Accessed January 2024.
  2. Bardia A, et al. N Engl J Med 2021;384(16):1529–1541.
  3. Loibl S, et al. ESMO 2021 (Poster #257P).
  4. Rugo H, et al. SABCS 2020 (Poster #PS11-09).
  5. Nagayama A, et al. Ther Adv Med Oncol 2020;12:1758835920915980.
  6. Stepan LP, et al. J Histochem Cytochem 2011;59(7):701–710.
  7. Shvartsur A, Bonavida B. Genes Cancer 2015;6(3–4):84–105.
  8. Sharkey RM, et al. Clin Cancer Res 2015;21(22):5131–5138.
  9. Goldenberg DM, et al. Oncotarget 2015;6(26):22496–22512.
  10. Rugo HS, et al. Future Oncol 2020;16(12):705–715.
  11. Goldenberg DM, Sharkey RM. Expert Opin Biol Ther 2020;20(8):871–885.
  12. Cardillo TM, et al. Bioconjug Chem 2015;26(5):919–931.
  13. Goldenberg DM, Sharkey RM. MAbs 2019;11(6):987–995.

March 2024 UK-TRO-0916

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.