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DATROWAY has serious Warnings and Precautions. Click here for more information.

Common adverse reactions in TROPION-Breast011,2

Most ARs were Grade 1 or 2

ARs in ≥10% of patients, % DATROWAY (n=360) Chemotherapy (n=351)
All Grades Grades 3 or 4 All Grades Grades 3 or 4
Gastrointestinal disorders Stomatitis* 59 7 17 2.6
Nausea 56 1.4 27 0.6
Constipation 34 0.3 17 0
Vomiting 24 1.1 12 1.1
Diarrhea 11 0.6 19 1.4
Abdominal pain* 11 0.6 15 1.4
General disorders Fatigue† 44 4.2 40 3.7
Skin and subcutaneous tissue disorders Alopecia 38 0 22 0
Rash* 19 0 17 2.3
Eye disorders Dry eye 27 0.8 13 0
Keratitis‡ 24 1.1 10 0
Metabolism and 
nutrition disorders Decreased appetite 16 1.4 16 0.9
Infections and infestations COVID-19* 16 1.4 13 0.9
Respiratory, thoracic, and mediastinal disorders Cough* 15 0 10 0
ARs in ≥10% of patients, % DATROWAY (n=360) Chemotherapy (n=351)
All Grades Grades 3 or 4 All Grades Grades 3 or 4
Gastrointestinal disorders
Stomatitis* 59 7 17 2.6
Nausea 56 1.4 27 0.6
Constipation 34 0.3 17 0
Vomiting 24 1.1 12 1.1
Diarrhea 11 0.6 19 1.4
Abdominal pain* 11 0.6 15 1.4
General disorders
Fatigue† 44 4.2 40 3.7
Skin and subcutaneous tissue disorders
Alopecia 38 0 22 0
Rash* 19 0 17 2.3
Eye disorders
Dry eye 27 0.8 13 0
Keratitis‡ 24 1.1 10 0
Metabolism and 
nutrition disorders
Decreased appetite 16 1.4 16 0.9
Infections and infestations
COVID-19* 16 1.4 13 0.9
Respiratory, thoracic, and mediastinal disorders
Cough* 15 0 10 0

Events were graded using National Cancer Institute Common Terminology Criteria (NCI CTCAE) version 5.0.1

*Includes other related terms.1

†Includes fatigue, asthenia, lethargy, malaise.1

‡Includes corneal disorder, corneal erosion, corneal infiltrates, corneal lesion, corneal toxicity, injury corneal, keratitis, keratopathy, punctate keratitis, and 
ulcerative keratitis.1

Dosage modifications due to ARs with DATROWAY1

3% discontinuation rate

22% dosage interruptions

23% dose reductions

Grade ≥3 TRAEs1,2

21% with DATROWAY

45% with chemotherapy§

Rates of Grade ≥3 neutropenia and G-CSF use2

  • 1% Grade ≥3 neutropenia
  • 3% G-CSF use

TRAEs refer to adverse events possibly related to treatment as assessed by the investigator. Adverse reactions refer to adverse events which have a likely basis for a causal relationship between the drug and the occurrence of the adverse event.2,3

§The most common grade ≥3 TRAEs with chemotherapy were neutropenia (31%), leukopenia (7%), and stomatitis (3%).2

Warnings and Precautions1

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 1365 patients from TROPION-Breast01 and other clinical trials.

ILD/pneumonitis (unresectable or metastatic breast cancer)||
  • DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In the pooled safety population of 841 patients with breast cancer from TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01, and TROPION-PanTumor02, ILD/pneumonitis occurred in 3% of patients treated with DATROWAY, including 0.4% of patients with Grade 3. There were two fatal cases (0.2%). The median time to onset was 5.3 months (range: 1.1-19.3 months) with a median duration of 1.2 months (range: 0.3-5.2 months). Eight patients (1%) had DATROWAY withheld and 10 patients (1.2%) permanently discontinued due to ILD/pneumonitis. Systemic corticosteroids were required in 64% (16/25) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients
Ocular adverse reactions (unresectable or metastatic breast cancer and other solid tumors)
  • DATROWAY can cause ocular ARs including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision
  • In the pooled safety population, ocular ARs occurred in 38% of patients treated with DATROWAY. Forty-two patients (3.1%) experienced Grade 3 ocular ARs, which included keratitis and dry eye, and 4 patients (0.3%) experienced a Grade 4 ocular AR of keratitis, corneal epithelium defect, corneal lesion, and conjunctival hemorrhage. The most common (≥5%) ocular ARs were dry eye (18%), keratitis (16%), increased lacrimation (6%), and conjunctivitis (5%). The median time to first onset was 2.3 months (range: 0.03-30 months) with a median duration of 2.3 months (range: 0.03-19.5 months). Of the patients who experienced ocular ARs, 39% had complete resolution, and 8% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow-up). Ocular ARs led to dosage interruption in 4.3%, dosage reductions in 2.8%, and permanent discontinuation in 0.9% of patients
Stomatitis (unresectable or metastatic breast cancer and other solid tumors)
  • DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis
  • In the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to onset was 0.5 months (range: 0.03-19.8 months) with a median duration of 1.1 months (range: 0.03-33.2 months). Stomatitis led to dosage interruption in 5%, dosage reductions in 11%, and permanent discontinuation in 0.4% of patients 
Embryo-fetal toxicity
  • DATROWAY can cause embryo-fetal harm

||A higher incidence of ILD/pneumonitis has been observed in patients with creatinine clearance (CLcr) 30 to <90 mL/min (estimated by Cockcroft Gault).1

  • Additional safety data for DATROWAY1

    The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR+/HER2– (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer in TROPION-Breast01.

    Median duration of treatment
    • 6.7 months (range: 0.7-16.1 months)
    Serious adverse reactions (>0.5% of patients)
    • Serious adverse reactions (>0.5% of patients) were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients and were due to ILD/pneumonitis
    Adverse reactions associated with discontinuations and dose modifications
    • Discontinuation (>0.5% of patients) included ILD/pneumonitis (1.7%) and fatigue (0.6%)
    • Dosage interruption (>1% of patients) included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%)
    • Dose reduction (>1% of patients) included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%)
    Other clinically relevant adverse reactions in <10% of patients
    • Infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis

Select TRAEs in TROPION-Breast012,4-6

The majority of select TRAEs with DATROWAY were Grade 1 or 2*

DATROWAY (n=360) Chemotherapy (n=351)
Select TRAEs, % Grade 1 Grade 2 Grade ≥3 Discontinuation rate Grade 1 Grade 2 Grade ≥3 Discontinuation rate
Oral mucositis/
stomatitis† 25 23 7 0.3 9 3.4 2.6 0
Adjudicated
drug-related ILD‡ 		1.4 1.1 0.8 1.4 0 0 0 0
Keratitis§ 11 2.5 0.6 0 4 0.9 0 0
Dry eye 19 1.9 0.6 0.3 7 0.9 0 0
Alopecia 21 15 0 0 10 10 0 0
Select
TRAEs, %		 DATROWAY (n=360)
Grade 1 Grade 2 Grade ≥3 Discontinuation rate
Oral mucositis/
stomatitis† 25 23 7 0.3
Adjudicated
drug-related ILD‡ 		1.4 1.1 0.8 1.4
Keratitis§ 11 2.5 0.6 0
Dry eye 19 1.9 0.6 0.3
Alopecia 21 15 0 0
Chemotherapy (n=351)
Grade 1 Grade 2 Grade ≥3 Discontinuation rate
Oral mucositis/
stomatitis† 9 3.4 2.6 0
Adjudicated
drug-related ILD‡ 		0 0 0 0
Keratitis§ 4 0.9 0 0
Dry eye 7 0.9 0 0
Alopecia 10 10 0 0

TRAEs refer to adverse events possibly related to treatment as assessed by the investigator.2

*Grades are based on NCI CTCAE version 5.0.6

†Includes aphthous ulcer, dysphagia, glossitis, mouth ulceration, odynophagia, oral mucosal blistering, oral pain, oropharyngeal pain, pharyngeal inflammation, and stomatitis.2

‡One patient had an adjudicated drug-related Grade 5 ILD event with DATROWAY.2

§Includes keratitis, punctate keratitis, and ulcerative keratitis.2

  • Defining Grade 1-2 select adverse reactions Grades shown on this page do not encompass all grades included in NCI CTCAE
    Oral mucositis/stomatitis1,6||
    • Grade 1: Asymptomatic or mild symptoms
    • Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
    Adjudicated drug-related ILD1,6||
    • Grade 1: Asymptomatic; consider corticosteroid treatment
    • Grade 2: Symptomatic; promptly initiate corticosteroid treatment; limiting instrumental activities of daily living
    Keratitis1,6||
    • Grade 1: Asymptomatic; clinical or diagnostic observations only
    • Grade 2: Symptomatic; moderate decrease in visual acuity
    Dry eye6*
    • Grade 1: Asymptomatic; clinical or diagnostic observations only; symptoms relieved by lubricants
    • Grade 2: Symptomatic; moderate decrease in visual acuity
    Alopecia6*
    • Grade 1: Hair loss of <50%#
    • Grade 2: Hair loss of ≥50% normal for individual; readily apparent to others**

    ||Grades are based on both the NCI CTCAE and the full Prescribing Information for DATROWAY.

    Best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline.6

    #A different hair style may be required to cover the hair loss but does not require a wig or hairpiece to camouflage.6

    **A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychological impact.6

Select laboratory abnormalities in TROPION-Breast011

The majority of select laboratory abnormalities were Grade 1 or 2
DATROWAY* Chemotherapy*
Select laboratory abnormalities (≥20%), % All Grades Grades 3 or 4 All Grades Grades 3 or 4
Hematology Decreased leukocytes 41 1.1 63 18
Decreased lymphocytes 36 9 42 11
Decreased hemoglobin 35 2.8 51 4.4
Decreased neutrophils  30 1.6 61 35
Chemistry Decreased calcium 39 1.4 43 1.2
Increased AST 23 1.9 28 0.9
Increased ALT 24 1.7 31 0.6
Increased alkaline phosphatase  23 0.6 20 0.6
DATROWAY* Chemotherapy*
Select laboratory abnormalities (≥20%), % All Grades Grades 3 or 4 All Grades Grades 3 or 4
Hematology
Decreased leukocytes 41 1.1 63 18
Decreased lymphocytes 36 9 42 11
Decreased hemoglobin 35 2.8 51 4.4
Decreased neutrophils  30 1.6 61 35
Chemistry
Decreased calcium 39 1.4 43 1.2
Increased AST 23 1.9 28 0.9
Increased ALT 24 1.7 31 0.6
Increased alkaline 
phosphatase 23 0.6 20 0.6

*The denominator used to calculate the rate varied from 264 to 359 based on the number of patients with a baseline value and at least one post-treatment value. Frequencies were based on NCI CTCAE version 5.0 grade-derived laboratory abnormalities.1

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; BICR, blinded independent central review; CDK, cyclin-dependent kinase; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; IV, intravenous; mBC, metastatic breast cancer; mPFS, median progression-free survival; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; TRAE, treatment-related adverse event; Trop-2, trophoblast cell-surface antigen 2.

ADC, antibody-drug conjugate; BICR, blinded independent central review; CDK, cyclin-dependent kinase; DCR, disease control rate; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; mBC, metastatic breast cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

BICR, blinded independent central review; CDK, cyclin-dependent kinase; Cl, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; G-CSF, granulocyte-colony stimulating factor; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ILD, interstitial lung disease; ISH, in situ hybridization; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q3W, once every three weeks; TRAE, treatment-related adverse event; Trop-2, trophoblast cell-surface antigen 2.

ADC, antibody-drug conjugate; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

5-HT3, 5-hydroxytryptamine type 3; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ILD, interstitial lung disease; Trop-2, trophoblast cell-surface antigen 2.

DNA, deoxyribonucleic acid; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mAb, monoclonal antibody; Trop-2, trophoblast cell-surface antigen 2.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

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Dosing

DATROWAY is the only Trop-2-directed ADC with Q3W dosing1,8-11

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