SAFETY
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Common adverse reactions in the pooled EGFRm mNSCLC population1,2*
The majority of adverse reactions were Grade 1 or 2 with DATROWAY*
|
Common adverse reactions (≥10%) in patients with locally advanced or metastatic EGFRm NSCLC on DATROWAY
|
DATROWAY (n=125) | ||
|---|---|---|---|
| All grades, % | Grades 3 or 4, % | ||
| Gastrointestinal disorders | Stomatitis† | 71 | 9 |
| Nausea | 50 | 0 | |
| Constipation | 31 | 0 | |
| Vomiting | 16 | 0.8 | |
| Diarrhea | 12 | 0 | |
| Skin and subcutaneous tissue disorders | Alopecia | 49 | 0 |
| Rash† | 20 | 0.8 | |
| Pruritus | 12 | 0 | |
| General disorders and administration site conditions | Fatigue‡ | 42 | 6 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal pain | 22 | 0.8 |
| Metabolism and nutrition disorders | Decreased appetite | 20 | 1.6 |
| Infections and infestations | COVID-19† | 19 | 2.4 |
| Respiratory, thoracic, and mediastinal disorders | Cough† | 18 | 0 |
| Dyspnea | 11 | 2.4 | |
| Eye disorders | Dry eye | 13 | 0 |
| Keratitis§ | 12 | 2.4 | |
| Injury, poisoning, and procedural complications | Infusion-related reaction† | 13 | 0 |
| Nervous system disorders | Headache | 13 | 0 |
|
Common adverse reactions (≥10%) in patients with locally advanced or metastatic EGFRm NSCLC on DATROWAY
|
DATROWAY (n=125) | |
|---|---|---|
| All Grades, % | Grades 3 or 4, % | |
| Gastrointestinal disorders | ||
| Stomatitis† | 71 | 9 |
| Nausea | 50 | 0 |
| Constipation | 31 | 0 |
| Vomiting | 16 | 0.8 |
| Diarrhea | 12 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 49 | 0 |
| Rash† | 20 | 0.8 |
| Pruritus | 12 | 0 |
| General disorders and administration site conditions | ||
| Fatigue‡ | 42 | 6 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain | 22 | 0.8 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 20 | 1.6 |
| Infections and infestations | ||
| COVID-19† | 19 | 2.4 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough† | 18 | 0 |
| Dyspnea | 11 | 2.4 |
| Eye disorders | ||
| Dry eye | 13 | 0 |
| Keratitis§ | 12 | 2.4 |
| Injury, poisoning, and procedural complications | ||
| Infusion-related reaction† | 13 | 0 |
| Nervous system disorders | ||
| Headache | 13 | 0 |
Grade ≥3 ARs2
24%
Discontinuation rate due to ARs
8%
43% dosage interruptions
26% dose reductions
Other clinically relevant ARs reported in <10% of patients included:
- Dry skin
- Blurred vision
- Abdominal pain
- Conjunctivitis
- Dry mouth
- ILD/pneumonitis
- Skin hyperpigmentation
- Increased lacrimation
- Visual impairment
Events were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.1
†Includes other related terms.1
‡Includes fatigue, asthenia, and malaise.1
§Includes corneal disorder, corneal erosion, keratitis, punctate keratitis, and ulcerative keratitis.1
In the EGFRm mNSCLC pooled patient population, adverse reactions of interest were mostly Grade 1 or 21,2*
Select adverse reactions |
DATROWAY (n=125) | |||
|---|---|---|---|---|
| Grade 1, % | Grade 2, % | Grade ≥3, % | Discontinuation rate, % | |
| Stomatitis | 37 | 26 | 9 | 0 |
| Keratitis | 6 | 4 | 2.4 | 0.8 |
| Dry eye | 11 | 1.6 | 0 | 0 |
| Adjudicated drug-related ILD | 0.8 | 2.4 | 0.8 | 2.4 |
No Grade 5 adverse reactions of special interest were observed in the pooled EGFRm NSCLC population.
*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.1
-
Defining Grade 1 to 2 select adverse reactions1,3Stomatitis*
- Grade 1: Asymptomatic or mild symptoms
- Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
Keratitis*- Grade 1: Asymptomatic; clinical or diagnostic observations only
- Grade 2: Symptomatic; moderate decrease in visual acuity
Dry eye†- Grade 1: Asymptomatic; clinical or diagnostic observations only; symptoms may be relieved by lubricants
- Grade 2: Symptomatic; moderate decrease in visual acuity
Adjudicated drug-related ILD*- Grade 1: Asymptomatic; consider corticosteroid treatment
- Grade 2: Symptomatic; promptly initiate corticosteroid treatment; limiting instrumental activities of daily living
*Grades are based on both the NCI CTCAE and the full Prescribing Information for DATROWAY.
†Grades are based on NCI CTCAE version 5.0.1,3
Grades shown here do not encompass all grades included in NCI CTCAE. Please refer to guidance on DATROWAY dosing modifications and adverse reaction management.
Warnings and Precautions
The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 1365 patients from TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01, and other clinical trials.
ILD/pneumonitis (locally advanced or metastatic NSCLC)*
- DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to first onset for ILD was 1.4 months (range: 0.2-9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients
Ocular adverse reactions (locally advanced or metastatic NSCLC 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 for ocular ARs 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 of DATROWAY in 0.9% of patients
Stomatitis (locally advanced or metastatic NSCLC 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 first onset of stomatitis 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 of DATROWAY 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 DATROWAY
The safety of DATROWAY was evaluated in 125 patients with locally advanced or metastatic EGFRm NSCLC from TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.
Median duration of treatment:- 6.1 months (range: 0.7-41.7 months)
Serious adverse reactions (>1% of patients):- COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%)
- Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified
Adverse reactions associated with discontinuations and dose modifications:- Discontinuation (>1% of patients) included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%)
- Dosage interruptions (>1% of patients) included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%)
- Dose reduction (>1% of patients) included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%), and COVID-19 (1.6%)
†The most common ocular adverse reactions included dry eye (13%) and keratitis (12%), which may be managed with prophylactic measures, such as lubricating eye drops and avoiding contact lenses. Monitor for signs and symptoms of ocular ARs, and promptly refer patients to an eye care professional, such as an optometrist or ophthalmologist, for any new or worsening ocular adverse reactions.1,4
Laboratory abnormalities in the pooled locally advanced or metastatic EGFRm NSCLC population1*
The majority of laboratory abnormalities were Grade 1 or 2
Select laboratory abnormalities (≥20%) that worsened from baseline in patients who received DATROWAY across three clinical trials |
DATROWAY | ||
|---|---|---|---|
| All grades, % | Grades 3 or 4, % | ||
| Hematology | Decreased hemoglobin | 34 | 4.8 |
| Decreased lymphocytes | 32 | 11 | |
| Decreased white blood cell count | 27 | 1.6 | |
| Chemistry | Increased calcium | 31 | 0 |
| Increased AST | 28 | 2.4 | |
| Increased lactate dehydrogenase | 23 | 0 | |
| Increased ALT | 20 | 2.4 | |
| Select laboratory abnormalities (≥20%) that worsened from baseline in patients who received DATROWAY across three clinical trials |
DATROWAY | |
|---|---|---|
| All grades, % | Grades 3 or 4, % | |
| Hematology | ||
| Decreased hemoglobin | 34 | 4.8 |
| Decreased lymphocytes | 32 | 11 |
| Decreased white blood cell count | 27 | 1.6 |
| Chemistry | ||
| Increased calcium | 31 | 0 |
| Increased AST | 28 | 2.4 |
| Increased lactate dehydrogenase | 23 | 0 |
| Increased ALT | 20 | 2.4 |
The denominator used to calculate the rate varied from 115 to 124 based on the number of patients with a baseline value and at least one post-treatment value. Frequencies were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 grade-derived laboratory abnormalities.
*The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01.1
ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; EGFRm, epidermal growth factor receptor-mutated; ILD, interstitial lung disease; IV, intravenous; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer.
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NCCN Recommendation
See the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for subsequent treatment recommendations