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Prescribing InformationIndicationPatient Site

PFS | 2-Year OS Update | Patients With Brain Metastases | Tumor Response

In combination with trastuzumab and capecitabineTUKYSA delivered superior results in the primary analysis of HER2CLIMB1

In patients treated with TUKYSA (tucatinib) + trastuzumab + capecitabine (TUKYSA arm) vs those treated with placebo + trastuzumab + capecitabine (control arm):

Progression-free survival
  • Primary endpoint: Median PFS: 7.8 months (95% CI: 7.5-9.6) in the TUKYSA arm vs 5.6 months (95% CI: 4.2-7.1) in the control arm; HR = 0.54 (95% CI: 0.42-0.71); P <0.000011*
     
  • Secondary endpoint: Median PFS in patients with brain metastases: 7.6 months (95% CI: 6.2-9.5) in the TUKYSA arm vs 5.4 months (95% CI: 4.1-5.7) in the control arm; HR = 0.48 (95% CI: 0.34-0.69); P <0.000011

Click here to see KM curves

Data from the first 480 patients.1CI = confidence interval; HR = hazard ratio; KM = Kaplan-Meier; OS = overall survival; PFS = progression-free survival.HER2CLIMB: Median overall survival at primary and exploratory follow-up analyses

Results of this prespecified exploratory analysis are descriptive, are not conclusive, are not controlled for type 1 error, and should be interpreted with caution. Data cutoff for follow-up analysis was February 8, 2021.2

  • These analyses are considered exploratory. No adjustments were made for multiple comparisons in the subgroup analyses
     
  • Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups

OS in the total population with updated prespecified data (N = 612)1,2

Efficacy results were consistent across patient subgroups defined by stratification factors and hormone receptor status.1

Data for select subgroupsOS results across select subgroups in the primary analysis1,3
  • Results of this exploratory subgroup analysis are descriptive but not conclusive, are not controlled for type 1 error, and should be interpreted with caution
     
  • Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups
     
  • Data cutoff for primary analysis was September 4, 20193
 Data from the patients in the United States and Canada were combined for this analysis.3ECOG = Eastern Cooperative Oncology Group; ER = estrogen receptor; PR = progesterone receptor.
  • These analyses are considered exploratory. No adjustments were made for multiple comparisons in the subgroup analyses
     
  • Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups
 See forest plotLoading Review safety data for 2-year follow-upLoadingOS results across select subgroups at exploratory follow-up analysis2,6
  • Results of this exploratory subgroup analysis are descriptive but not conclusive, are not controlled for type 1 error, and should be interpreted with caution
     
  • Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups
     
  • Data cutoff for follow-up analysis was February 8, 20212
Data from the patients in the United States and Canada were combined for this analysis.3ECOG = Eastern Cooperative Oncology Group; ER = estrogen receptor; ITT = intent-to-treat; PR = progesterone receptor.HER2CLIMB: Exploratory follow-up analyses

Tab Number 5

Time to New Lesions

CNS-PFS

Intracranial ORR

Tab Number 4

HER2CLIMB: Time to new brain lesions or death at exploratory follow-up analysis
  • Results of this exploratory analysis are descriptive but not conclusive, and they are not controlled for type 1 error. Due to a high rate of censoring of patients owing to extra-CNS progression, results should be interpreted with caution. Data cutoff for follow-up analysis was February 8, 20214
     
  • Brain lesion development was detected through use of brain MRI scans. All patients received a baseline brain MRI scan. Only patients with a history or baseline presence of brain metastases were scanned at regular intervals throughout the trial. Unless clinically indicated, patients with no history of brain metastases were not routinely scanned. This depiction is limited to patients who were rescanned through the trial7

Time from randomization to new brain lesion development as the first site of progression per investigator assessment or death in patients with or without brain metastases at baseline (N = 612)4*

 CNS = central nervous system; MRI = magnetic resonance imaging; NE = not estimable.

Results of this post-hoc, exploratory analysis are descriptive, but they are not conclusive, are not controlled for type 1 error, and should be interpreted with caution. Data cutoff for follow-up analysis was February 8, 2021.4

CNS-PFS in patients with brain metastases at baseline (n = 291)4,8*†

 CNS-PFS was defined as the time from randomization to disease progression in the brain by investigator assessment or death. Progression in the brain was evaluated by applying RECIST, version 1.1, to assess brain lesions in isolation from other organs.4The results are estimates (not exact numbers). Due to a high rate of censoring patients owing to extra-CNS progression, results should be interpreted with caution.CNS = central nervous system.

Results of this post-hoc, exploratory analysis are descriptive, but they are not conclusive, are not controlled for type 1 error, and should be interpreted with caution. Data cutoff for follow-up analysis was February 8, 2021.4

 Intracranial response was assessed by investigators according to RECIST, version 1.1, in patients with measurable intracranial lesions at baseline.4CR = complete response; ORR = objective response rate; ORR-IC = intracranial objective response rate; PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors.
HER2CLIMB: Confirmed tumor response and time to response
Confirmed ORR1
  • 40.6% (n = 138/340; 95% CI: 35.3-46.0; CR = 0.9%; PR = 39.7%) with TUKYSA + trastuzumab + capecitabine vs 22.8% (n = 39/171; 95% CI: 16.7-29.8; CR = 1.2%; PR = 21.6%) with placebo + trastuzumab + capecitabine; P = 0.00008 (secondary endpoint)
 Median time to response in HER2CLIMB10
  • Median time to response was 6 weeks in both treatment arms
     
  • Results of this exploratory analysis are descriptive only and are not contained in the approved product labeling
HER2CLIMB exploratory analysis: OS in patients with stable disease as best overall response (n = 343)6*

Results of this exploratory subgroup analysis are descriptive but not conclusive, are not controlled for type 1 error, and should be interpreted with caution.

  • Median OS: 21.8 months (95% CI: 18.1-NE) in the TUKYSA arm vs 15.2 months (95% CI: 12.0-20.0) in the control arm; HR = 0.60 (95% CI: 0.41-0.88)6
    • Number of deaths: 65/217 in the TUKYSA arm vs 53/126 in the control arm
       
  • Stable disease rates in HER2CLIMB11:
    • 45.6% (155/340) in the TUKYSA arm
    • 58.5% (100/171) in the control arm
Analysis included patients in total population whose confirmed best overall response by BICR was classified as one of the following: SD or non-CR/non-PD.6SD was defined using RECIST, version 1.1, as neither sufficient shrinkage to qualify as a PR (PR was defined as ≥30% decrease) nor sufficient increase to qualify as PD (PD was defined as ≥20% increase).11,12BICR = blinded independent central review; CR = complete response; ORR = objective response rate; PD = progressive disease; PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors; SD = stable disease.HER2CLIMB: PFS in patients with and without brain metastasesPrimary endpoint populationIn combination with trastuzumab and capecitabineTUKYSA significantly reduced the risk of disease progression or death1

PFS per BICR in the first 480 patients randomized1

 Patients with brain metastasesIn combination with trastuzumab and capecitabineTUKYSA extended PFS in patients with brain metastases1

PFS per BICR in patients with brain metastases at baseline (n = 291)1,3*

 Analysis includes patients with history or presence of parenchymal brain metastases at baseline, including target and nontarget lesions. Analysis does not include patients with dural lesions only.1Patients without brain metastasesHER2CLIMB exploratory analysis: PFS in patients without brain metastases11

Results of this exploratory subgroup analysis are descriptive but not conclusive, are not controlled for type 1 error, and should be interpreted with caution.

PFS per BICR in patients without brain metastases at baseline (n = 319)

 Next: Review the safety profile >LoadingReferences:TUKYSA. Prescribing information. Seagen Inc.; 2023. Curigliano G, Mueller V, Borges V, et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Ann Oncol. 2022;33(3):321-329. doi:10.1016/j.annonc.2021.12.005Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl Med. 2020;382(7):597-609. doi:10.1056/NEJMoa1914609Lin NU, Murthy RK, Abramson V, et al. Tucatinib vs placebo, both in combination with trastuzumab and capecitabine, for previously treated ERBB2 (HER2)-positive metastatic breast cancer in patients with brain metastases: updated exploratory analysis of the HER2CLIMB randomized clinical trial. JAMA Oncol. 2023;9(2):197-205. doi:10.1001/jamaoncol.2022.5610Curigliano G, Mueller V, Borges V, et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Poster presented at: American Society of Clinical Oncology Annual Meeting; June 4-8, 2021.Data on file. Seagen Inc.Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med. 2020;382(7):597-609. Protocol. doi:10.1056/NEJMoa1914609Lin NU, Murthy RK, Abramson V, et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Poster presented at: San Antonio Breast Cancer Symposium; December 7-10, 2021; San Antonio, TX. Lin NU, Borges V, Anders C, et al. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2+ metastatic breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol. 2020;38(23):2610-2619. doi:10.1200/JCO.20.00775Curigliano G, Murthy R, Loi S, et al. Tucatinib vs placebo added to trastuzumab and capecitabine in previously treated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Ann Oncol. 2020;31(suppl 2):S62-S63. doi:10.1016/j.annonc.2020.03.238Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med. 2020;382(7):597-609. Supplementary appendix. doi:10.1056/NEJMoa1914609Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. doi:10.1016/j.ejca.2008.10.026
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PP-T1K-USA-0635
IndicationTUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Important Safety Information Warnings and Precautions
  • Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA. 


    In HER2CLIMB, when TUKYSA was given in combination with trastuzumab and capecitabine, 81% of patients who received TUKYSA experienced diarrhea, including 0.5% with Grade 4 and 12% with Grade 3. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. Median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to TUKYSA dose reductions in 6% of patients and TUKYSA discontinuation in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB. 
  • Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA. 


    In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 x ULN, 6% had an AST increase >5 x ULN, and 1.5% had a bilirubin increase >3 x ULN (Grade ≥3). Hepatotoxicity led to TUKYSA dose reductions in 8% of patients and TUKYSA discontinuation in 1.5% of patients. 
  • Embryo-Fetal Toxicity: TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for 1 week after the last dose. 
 Adverse Reactions  In HER2CLIMB, serious adverse reactions occurred in 26% of patients who received TUKYSA; the most common (in ≥2% of patients) were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.   Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; the most common (in ≥1% of patients) were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; the most common (in ≥2% of patients) were hepatotoxicity (8%) and diarrhea (6%).  The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash. Lab Abnormalities In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST.  The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed. Drug Interactions 
  • Strong CYP3A/Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA. 
  • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
  • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage. 
  • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity. 
Use in Specific Populations 
  • Lactation: Advise women not to breastfeed while taking TUKYSA and for 1 week after the last dose.
  • Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment. 
  • Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.
REF-T1K1161_FINAL_01/23
Please see full Prescribing Information.IndicationTUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
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