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Adverse event reporting can be found at the bottom of the page
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For TUKYSA® (tucatinib) Prescribing information click here. For Trazimera® (trastuzumab) Prescribing information click here.
HER2CLIMB was a phase III study assessing the efficacy and safety of TUKYSA combination (tucatinib + trastuzumab + capecitabine; n=410) vs. control (placebo + trastuzumab + capecitabine; n=202) in patients with HER2+ MBC previously treated with trastuzumab, pertuzumab or T-DM1.9 The primary endpoint of HER2CLIMB was PFS assessed by BICR; key secondary endpoints included PFS in patients with brain metastasis at baseline assessed by BICR, OS in the ITT population and safety.9
Adapted from: Murthy R, et al. N Engl J Med. 2020;382(7):597–609.
Data cut-off: 4 September 2019 (Primary analysis; median follow-up: 14.0 months).9
*As assessed by blinded independent central review.9
†PFS was evaluated in the first 480 randomised patients.9
Adapted from: Murthy R, et al. N Engl J Med. 2020;382(7):597–609.
Data cut-off: 4 September 2019 (Primary analysis; median follow-up: 14.0 months).9
*The ITT population (N=612) included more patients than the primary endpoint population to ensure there was adequate statistical power to assess key secondary endpoints.9
Adapted from: Lin NU, et al. JAMA Oncol. 2023;9:197–205.
Data cut-off: 8 February 2021 (median follow-up: 29.6 months).6
Data from an exploratory post hoc analysis of PFS in brain metastases subgroup from the final analysis.6 Results should be interpreted with caution. HER2CLIMB was not powered to assess a statistical difference between treatment groups at this time point, or to assess significance for this observation.6
*Using RECIST 1.1 criteria to assess brain lesions in isolation from other organs, based on investigator assessment.6
Adapted from: Bachelot T, et al. ESMO 2020; Poster 2073.
Data cut-off: 4 September 2019 (median follow-up: 14.0 months).9
Data from exploratory post hoc analysis of new brain lesion-free survival.12 Results should be interpreted with caution. HER2CLIMB was not powered to assess a statistical difference between treatment groups at this time point, or to assess significance for this observation.6Table Title: Adverse events in ≥20% of patients in the TUKYSA arm of the HER2CLIMB trial13
TUKYSA COMBINATION (n=404) | Control (n=197) | |||
|---|---|---|---|---|
| Any grade, n (%) | Grade ≥3, n (%) | Any grade, n(%) | Grade ≥3, n(%) | |
| Any adverse event | 401 (99.3) | 245 (60.6) | 191 (97.0) | 101 (51.3) |
| Diarrhoea | 333 (81.9) | 53 (13.1) | 106 (53.8) | 17 (8.6) |
| PPE syndrome | 264 (65.3) | 57 (14.1) | 105 (53.3) | 18 (9.1) |
| Nausea | 243 (60.1) | 16 (4.0) | 88 (44.7) | 7 (3.6) |
| Fatigue | 193 (47.8) | 22 (5.4) | 87 (44.2) | 8 (4.1) |
| Vomiting | 152 (37.6) | 13 (13.2) | 51 (25.9) | 8 (4.1) |
| Decreased appetite | 105 (26.0) | 3 (0.7) | 41 (20.8) | 0 |
| Stomatitis | 105 (26.0) | 10 (2.5) | 28 (14.2) | 1 (0.5) |
| Headache | 96 (23.8) | 3 (0.7) | 40 (20.3) | 3 (1.5) |
| AST increased | 89 (22.0) | 19 (4.7) | 22 (11.2) | 1 (0.5) |
| Anaemia | 88 (21.8) | 17 (4.2) | 24 (12.2) | 5 (2.5) |
| ALT increased | 85 (21.0) | 23 (5.7) | 13 (6.6) | 1 (0.5) |
| Increased bilirubin | 81 (20.0) | 4 (1.0) | 21 (10.7) | 5 (2.5) |
Adapted from: Curigliano G, et al. Ann Oncol. 2022;33(3):321–329.
Data cutoff: 8 February 2021; median follow-up: 29.6 months.13
Please note this is not an exhaustive list of adverse events that may be experienced with TUKYSA treatment. For full safety profile information and guidance on the management of adverse events, please refer to the TUKYSA Summary of Product Characteristics.
Adverse events leading to discontinuation in the HER2CLIMB trial14
| Header | TUKYSA combination n(%) (n=404) | Control (n=197) n(%) | |
|---|---|---|---|
| Adverse events leading to TUKYSA/placebo discontinuation | 25 (6.2) | 7 (3.6) | |
| Adverse events leading to trastuzumab discontinuation | 19 (4.7) | 6 (3.0) | |
| Adverse events leading to capecitabine discountination | 50 (12.4) | 19 (9.6) | |
POTENT INHIBITION
TUKYSA combination achieves greater anti-tumour activity than trastuzumab + capecitabine combination alone1-4,9
BRAIN ACTIVITY
TUKYSA penetrates the blood-brain barrier more efficiently than trastuzumab alone5
HIGH SELECTIVITY
In vitro, TUKYSA is >1,000x more selective for HER2 than for EGFR2
Highly selective inhibition of HER2 could minimise off-target effects2
This real-world evidence study was not been designed to be compared with results from randomised clinical trials. The limitations of real-world studies include: generalisability of finding beyond the population studied, residual confounding and bias, limited internal validity, potential data quality, and methodology issues.
A retrospective US cohort study using a nationwide, deidentified electronic health record–derived Flatiron Health metastatic breast cancer database included patients ≥18 years old who had been diagnosed with HER2+ mBC from Jan 2017 – Dec 2022 and treated with TUKYSA combination. This study aimed to describe baseline demographic and clinical characteristics, treatment patterns and clinical outcomes. Clinical outcomes included real-world overall survival time to discontinuation and time to next treatment.15
Of 32,819 patients with MBC diagnosis between Jan 2017 – Dec 2022, 3,449 had evidence of HER2+ disease and 89 patients were treated with TUKYSA combination after at least 2 prior anti-HER2 treatment regimens.16
Outcomes are from an additional subgroup analysis of Kaufman PA, et al. Front Oncol. 2023;13:1264861. Data was generated using the same methodology as the original study (FLATIRON) and should be interpreted with caution.15,16
* Time from treatment initiation to start of the the subsequent line of therapy. All treatments that began within 28 days of the first treatment date were considered part of the same line of therapy.15
† Time from treatment initiation to discontinuation. Where physician-indicated end date was not provided, treatment discontinuation was defined as a treatment gap of >60 days from the last medication date for a regimen.15
ALT: Alanine Aminotransferase, AST: Aspartate Aminotransferase, BICR: Blinded Independent Committee Review, CNS-PFS: Central Nervous System – Progression-Free Survival, ECOG PS: Eastern Cooperative Oncology Group performance status, EGFR: Epidermal Growth Factor Receptor, HER2: Human Epidermal Growth Factor Receptor 2, IQR: interquartile range, ITT: Intention-to-Treat, MBC: Metastatic Breast Cancer, NR: Not Reached, OS: overall survival, PFS: Progression-Free Survival, PPE: Palmar–Plantar Erythrodysesthesia, RECIST: Response Evaluation Criteria in Solid Tumors, T-DM1: Trastuzumab Emtansine, T-DXd: Trastuzumab Deruxtecan, TKI: Tyrosine Kinase Inhibitor.
References:
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search
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