Trodelvy

Indication


TRODELVY® as monotherapy is reimbursed for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease10,11,12

Reimbursementen

▼ This medical product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.


Clinical practice guidelines


ESMO recommends TRODELVY® as a preferred treatment option in 2L mTNBC33


GuidelinesEn

 

ESMO clinical guidelines10



ESMO scores TRODELVY® as 4 out of 5 on the ESMO-Magnitude of clinical benefit scale13


Guidelines3

ESMO-MCBS score TRODELVY®13


ESMO-Magnitude of clinical benefit scale (ESMO-MCBS) was developed in 2015 as a tool to assess the magnitude of clinical benefit from new anti-cancer therapies and has been widely applied in clinical and in health technology assessment settings.

Based on clinical trials results, the scale considers – in the curative and non-curative settings - overall survival, progression-free survival, disease free survival, hazard ratio, response rate, quality of life, prognosis of the condition and toxicity.

Treatments that have an ESMO-MCBS score of 4 and 5 for non-curative therapies are highlighted for accelerated assessment of value and cost-effectiveness.

Based on the ESMO-MCBS evaluation, TRODELVY® obtained a score of 4 out of 5 demonstrating a significant clinical benefit for the patients with metastatic triple negative breast cancer.

Mechanism of action

TRODELVY® is the first and only approved TROP-2 directed ADC. 

TRODELVY® dellvers a potent cytotoxic payload combined with a TROP-2 directed antibody to mTNBC cells tumours14,15,16,17


Mechanism of action trop2

2L+, second line and beyond; ADC, antibody-drug conjugate; mTNBC, metastatic triple-negative breast cancer; SN-38, active metabolite of irinotecan; TNBC, triple-negative breast cancer; TROP-2, trophoblast cell surface antigen 2.
2. Bardia A, et al. N Engl J Med. 2021;384(16):1529-1541. 3. Shvartsur A, Bonavida B. Genes Cancer. 2015;6(3-4):84-105. 4. Goldenberg DM, et al. Oncotarget. 2015;6(26):22496-22512. 5. Rugo HS, et al. Future Oncol. 2020;16(12):705-715. 6. TRODELVY® (sacituzumab govitecan) Summary of Product Characteristics. Gilead Sciences Belgium.


TRODELVY® is a TROP-2 directed ADC that delivers SN-38 to TNBC tumours30,31,17,18,19,20


TRODELVY® is a paradigm shifting TROP-2-Directed ADC that concentrates cytotoxic playload intracellularly while concurrently facilitating its extracellular release into the tumor microenvironment


Mechanism of actionEn

ADC, antibody-drug conjugate; SN-38, active metabolite of irinotecan; TNBC, triple-negative breast cancer; TOPO I, topoisomerase 1; TROP-2, trophoblast cell surface antigen 2.

Mechanism of action video


See how TRODELVY® works to deliver SN-38 directly to TNBC tumour cells, ensuring a cytotoxic effect to the tumour while limiting toxicity to healthy tissues.


Trial design


Phase 3 ASCENT clinical study


Trial design new1 

*PFS measured by an independent centralized and blinded group of radiology experts who assessed tumor response using RECIST 1.1 criteria in patients without brain metastasis. (n=468)


Efficacy

Median PFS with TRODELVY® was nearly 3X LONGER than chemotherapy22

Progression-free Survival*22

MedianPfs En

The median PFS in the total ITT population (all patients with or without brain metastases) was 4.8 months on TRODELVY® versus 1.7 months on chemotherapy (HR: 0.43; p<0.001).22

The improvement in PFS in patients without known brain metastases was consistent with that observed for the overall ITT population (5.6 months on treatment with TRODELVY® versus 1.7 months on chemotherapy (HR: 0.41; p<0.001).

The primary analysis population consisted of patients without known brain metastases at baseline (n=468).

The ITT population consisted of all patients with or without brain metastases at baseline (n=529).



Median OS of 1 YEAR with TRODELVY®22

Overall survival*22

MedianOs En

The median OS in the total ITT population (all patients with or without brain metastases) was 11.8 months on treatment with TRODELVY® versus 6.9 months on chemotherapy (HR: 0.51; p<0.001).22

The improvement in OS in patients without known brain metastases was consistent with that observed for the overall ITT population (12.1 months on treatment with TRODELVY® versus 6.7 months on chemotherapy (HR: 0.48; p<0.001).

The primary analysis population consisted of patients without known brain metastases at baseline (n=468).

The ITT population consisted of all patients with or without brain metastases at baseline (n=529).



TRODELVY® delivered NEARLY 8X GREATER response rate than chemotherapy22

Overall response rate+22

ORR En

The ORR in the total ITT population (all patients with or without brain metastases) was 31% on treatment with TRODELVY® versus 4% on chemotherapy (OR:10.99 (95% CI, 5.66-21.36) p<.001).22

†The ORR results in the primary analysis population were consistent with the ITT population (OR: 35% vs. 5%; OR: 10.86; 95% CI, 5.59-21.0). The primary analysis population consisted of patients without brain metastases at baseline (n=468). The ITT population consisted of all patients with or without brain metastases at baseline (N=529).22

The median duration of response was 6.3 months with TRODELVY® (range: 5.5-9.0) versus 3.6 months with single agent chemotherapy (range: 2.8-NE).22


*Based on objective response rates for TRODELVY® and single-agent chemotherapy.

‡Complete response (CR): disappearance of all target lesions. All pathological lymph nodes (both target and non-target lesions) should be reduced to <10 mm on the short axis.29

§Partial response (PR): at least 30% reduction in the total diameter of the target lesions, using the total sum of diameters at baseline as a reference.29



Adverse event management


TRODELVY® has a well-characterised safety profile12,22

"Adverse events leading to treatment discontinuation were infrequent, occurring in 12 patients (5%) in each group."

Bardia A, Hurcitz SA, Tolaney SM, et al; for the ASCENT Clinical Trial Investigators


TableResults

For the full list of side effects please refer to SmPC

*The neutropenia category included neutropenia and decreased neutrophil count.

†The anaemia category included anaemia, decreased hemoglobin level, and decreased red-cell count.

‡The leukopenia category included leukopenia and decreased white-cell count.

In the Phase 3 ASCENT Trial:

<5%
of patients discontinued TRODELVY® for any adverse reaction4
NO
drug-related deaths in the TRODELVY® group4

No patients in the TRODELVY group discontinued treatment due to treatment-related neutropenia or diarrhoea22

*Based on pooled data from two clinical trials (ASCENT and IMMU-132-01) involving 366 patients who received TRODELVY®.1



Early detection and proactive management can help control side effects

Step-by-step management

Image 11-ENG

Dose modifications for severe non-neutropenic toxicity

Diarrhoea new1



Step-by-step management

Image 13-ENG 

Recommanded dose modifications for severe neutropenia12

Neutropinia new1


Dosing & administration


The recommended dose of TRODELVY® is 10 mg/kg

The recommended dose of TRODELVY® is 10 mg/kg intravenously on Days 1 and 8 of 21-day treatment cycles. Dose is calculated based on patient body weight at the beginning of each cycle9,10,11,12

  • Continue treatment until disease progression or unacceptable toxicity
  • Administer TRODELVY® as an intravenous infusion only. Do not administer as an intravenous push or bolus
Dosing En1

Dosing En2

Learn how to appropriately prepare, administer, and premedicate patients receiving TRODELVY®


Meet our team

Eveline Baelen - Card List

Eveline Baelen

Senior Therapeutic Specialist Belgium North
Contact
Carine-Smet-Card-List-With-Phone

Carine Smet

Senior Therapeutic Specialist Belgium Center
Contact
Jean-Pol-Guillaume - Card List

Jean-Pol Guillaume

Senior Therapeutic Specialist Belgium South
Contact
Photo-Annelies-Laeremans-with-QR

Annelies Laeremans

Associate Director Medical Affairs Oncology
Contact
logotipo_gilead
Request for Medical Information
Contact
Claudia-Freitag-With-Phone

Claudia Freitag

Senior Medical Manager Oncology
Contact
Abbreviations

2L+, second line and beyond; ADC, antibody-drug conjugate; AR, adverse reaction; BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; HRQoL, health-related quality of life; ITT, intent-to-treat; IV, intravenous; mTNBC, metastatic triple-negative breast cancer; NE, not estimable; OR, odds ratio; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; TNBC, triple-negative breast cancer; TROP-2, trophoblast cell surface antigen 2; QoL, quality of life; UGT1A1, uridine diphosphate-glucuronosyl transferase 1A1.

Sources
  1. 1. DeSantis et al. CA: a cancer journal for clinicians, 2016; 66(1), 31-42.
  2. 2. Annual Report to the Nation on the Status of Cancer, 1975-2011.
  3. 3. Plasilova et al. Medicine, 2016; 95(35).
  4. 4. Lei et al. Cancer Communications, 41(11), 1183-1194.
  5. 5. Van Hal et al. Arch Public Health, 2018; 58, 307-19.
  6. 6. Neyt et al. Journal of psychosocial oncology, 2006; 24(3), 89-123.
  7. 7. Kassam et al. Clinical breast cancer, 2009; 9(1), 29-33.
  8. 8. Anders et al. Hematology/Oncology Clinics, 2013; 27(4), 737-749.
  9. 9. Cardoso et al. The Breast, 2017; (31), 244-259.
  10. 10. Cardoso et al. Annals of Oncology, 2020; 31(12), 1623-1649.
  11. 11. Gradishar et al.  J Nat Comp Cancer Net, 2021; 19(5), 484-493.
  12. 12. TRODELVY® (sacituzumab govitecan) Summary of Product Characteristics. Gilead Sciences Belgium.
  13. 13. ESMO MCBS Sacituzumab Govitecan. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-271-1
  14. 14. Goldenberg et al. MAbs, 2019(11), 987-995.
  15. 15. Finn et al. NEJM, 2016; 375(20), 1925-1936.
  16. 16. Mancini et al. Cancers, 2014; 6(4), 2187-2223.
  17. 17. Verma et al. NEJM, 2012; 367(19), 1783-1791.
  18. 18. Ribnikar et al. Current treatment options in oncology, 2014; 16(4), 1-24.
  19. 19. Sahota et al. Expert Opinion on Biological Therapy, 2017; 17(8), 1027-1031.
  20. 20. Fenn et al. Drugs of today, 2019; 55(9), 575.
  21. 21. Team et al. Canadian Journal of Health Technologies, 2022; 2(2).
  22. 22. Bardia A, et al. N Engl J Med. 2021;384(16):1529-1541.
  23. 23. Burki et al. The Lancet Oncology, 2017; 18(5), e246.
  24. 24. Kalinsky et al. Annals of Oncology, 2020; 31(12), 1709-1718.
  25. 25. Bardia et al. Annals of Oncology, 2021; 32(9), 1148-1156.
  26. 26. Schreiber et al. Expert review of anticancer therapy, 2021; 21(12), 1303-1311
  27. 27. Spring et al. The Oncologist, 2021; 26(10), 827-834.
  28. 28. Seligson et al. Annals of Pharmacotherapy, 2021; 55(7), 921-931.
  29. 29. RECIST version 1.1 criteria. https://recist.eortc.org/recist-1-1-2/ Accessed June 2023
  30. 30. Rugo HS, et al. Future Oncol. 2020;16(12):705-715
  31. 31. Goldenberg DM, et al. Oncotarget. 2015;6:22496-22512
  32. 32. Rugo H, et al. Poster. SABCS [virtual meeting]. 2020 (abstr PS11-09).
  33. 33. Gennari et al. Ann Oncol 2021;32(12): 1475-1495. ESMO Metastatic Breast Cancer Living Guidelines, v1.1 May 2023.

BE-TRO-0080