LAZCLUZE

5 WARNINGS AND PRECAUTIONS Venous Thromboembolic Events (VTE) : Prophylactic anticoagulation is recommended for the first four months of treatment. Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose at the discretion of the healthcare provider. Permanently discontinue amivantamab and continue LAZCLUZE for recurrent VTE despite therapeutic anticoagulation. ( 2.3 , 2.4 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Withhold LAZCLUZE and amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. ( 2.4 , 5.2 ) Dermatologic Adverse Reactions : Can cause severe rash including acneiform dermatitis. At treatment initiation, prophylactic and concomitant medications are recommended. Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity. ( 2.3 , 2.4 , 5.3 ) Hepatotoxicity : Can cause severe hepatotoxicity (including increased ALT and AST). Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity. ( 2.4 , 5.4 ) Ocular Adverse Reactions : Promptly refer patients with new or worsening signs and symptoms of ocular adverse reactions, including keratitis, to an ophthalmologist for evaluation. Withhold, reduce the dose, or permanently discontinue amivantamab and continue LAZCLUZE based on severity. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Venous Thromboembolic Events LAZCLUZE in combination with amivantamab can cause serious and fatal venous thromboembolic events (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE). The majority of these events occurred during the first four months of therapy [see Adverse Reactions (6.1) ] . In MARIPOSA [see Adverse Reactions (6.1) ] , VTE occurred in 36% of patients receiving LAZCLUZE in combination with amivantamab, including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 7% of patients had VTE leading to dose interruptions of LAZCLUZE, 0.5% of patients had VTE leading to dose reductions of LAZCLUZE, and 1.9% of patients permanently discontinued LAZCLUZE due to VTE. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the first four months of treatment [see Dosage and Administration (2.3) ] . The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4) ]. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue amivantamab. Continue treatment with LAZCLUZE at the same dose level at the discretion of the healthcare provider [see Dosage and Administration (2.4) ] . Refer to the amivantamab prescribing information for recommended amivantamab dosage modification. 5.2 Interstitial Lung Disease (ILD)/Pneumonitis LAZCLUZE in combination with amivantamab can cause interstitial lung disease (ILD)/pneumonitis. In MARIPOSA [see Adverse Reactions (6.1) ], ILD/pneumonitis occurred in 3.1% of patients treated with LAZCLUZE in combination with amivantamab, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) of ILD/pneumonitis and 2.9% of patients permanently discontinued LAZCLUZE and amivantamab due to ILD/pneumonitis [see Adverse Reactions (6.1) ]. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LAZCLUZE and amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed [see Dosage and Administration (2.4) ]. 5.3 Dermatologic Adverse Reactions LAZCLUZE in combination with amivantamab can cause severe rash including dermatitis acneiform, pruritus and dry skin. In MARIPOSA [see Adverse Reactions (6.1) ] , rash occurred in 86% of patients treated with LAZCLUZE in combination with amivantamab, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose reduction of LAZCLUZE occurred in 19% of patients, rash leading to dose interruption of LAZCLUZE occurred in 30% of patients, and LAZCLUZE was permanently discontinued due to rash in 1.7% of patients [see Adverse Reactions (6.1) ]. When initiating treatment with LAZCLUZE in combination with amivantamab, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions [see Dosage and Administration (2.3) ]. Instruct patients to limit sun exposure during and for 2 months after treatment with LAZCLUZE in combination with amivantamab. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, administer oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4) ] . 5.4 Hepatotoxicity LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST). In MARIPOSA [see Adverse Reactions (6.1) ], based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%. Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4) ]. 5.5 Ocular Toxicity LAZCLUZE, in combination with amivantamab, can cause ocular toxicity, including keratitis. In MARIPOSA [see Adverse Reactions (6.1) ] , ocular toxicity occurred in 16% of patients treated with LAZCLUZE in combination with amivantamab, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, reduce the dose or permanently discontinue amivantamab and continue LAZCLUZE based on severity [see Dosage and Administration (2.4) ] . 5.6 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, LAZCLUZE can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of lazertinib to pregnant animals during the period of organogenesis resulted in reduced embryo-fetal survival and fetal body weight in rats and malformations in rabbits at exposures approximately 4 and 0.5 times, respectively, the human exposure at the recommended dose of 240 mg/day based on AUC. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose [see Use in Specific Populations (8.1 , 8.3) ].

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Venous Thromboembolic Events [see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Ocular Toxicity [see Warnings and Precautions (5.5) ] LAZCLUZE in Combination with Amivantamab The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction (amivantamab), musculoskeletal pain, edema, stomatitis, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, and nausea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in WARNINGS AND PRECAUTIONS and below reflect exposure to LAZCLUZE in combination with amivantamab in 421 previously untreated patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations in MARIPOSA [see Clinical Studies (14) ] . Patients received LAZCLUZE 240 mg orally once daily in combination with amivantamab intravenously at 1,050 mg (for patients < 80 kg) or 1,400 mg (for patients ≥ 80 kg) once weekly for 4 weeks, then every 2 weeks thereafter starting at week 5. Among the 421 patients who received LAZCLUZE in combination with amivantamab, 84% were exposed to LAZCLUZE for ≥ 6 months and 73% were exposed to LAZCLUZE for > 1 year. The median age of patients who received LAZCLUZE in combination with amivantamab was 64 years (25 to 88); 64% were female; 59% were Asian, 38% were White, 1.7% were American Indian or Alaska Native, 0.7% were Black or African American, 1% were of unknown or other races; 13% were Hispanic or Latino; 67% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 33% had ECOG PS of 0; 60% had EGFR exon 19 deletions, and 40% had EGFR exon 21 L858R substitution mutations. Serious adverse reactions occurred in 49% of patients who received LAZCLUZE in combination with amivantamab. Serious adverse reactions occurring in ≥ 2% of patients included VTE (11%), pneumonia (4%), rash and ILD/pneumonitis (2.9% each), COVID-19 (2.4%), and pleural effusion and infusion-related reaction (amivantamab) (2.1% each). Fatal adverse reactions occurred in 7% of patients who received LAZCLUZE in combination with amivantamab due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). Permanent discontinuation of LAZCLUZE due to an adverse reaction occurred in 21% of patients. Adverse reactions which resulted in permanent discontinuation of LAZCLUZE in ≥ 1% of patients included ILD/pneumonitis, pneumonia, VTE, rash, respiratory failure, and sudden death. Dosage interruption of LAZCLUZE due to an adverse reaction occurred in 72% of patients. Adverse reactions which required dosage interruption in ≥ 5% of patients were rash, nail toxicity, COVID-19, VTE, increased ALT, and increased AST. Dose reductions of LAZCLUZE due to an adverse reaction occurred in 42% of patients. Adverse reactions requiring LAZCLUZE dose reductions in ≥ 5% of patients were rash and nail toxicity. The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction (amivantamab), musculoskeletal pain, edema, stomatitis, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium. Table 3 summarizes the adverse reactions (≥ 10%) in MARIPOSA. Table 3: Adverse Reactions (≥ 10%) in Patients with NSCLC with Exon 19 Deletion or Exon 21 L858R Substitution Mutations in MARIPOSA Adverse Reaction LAZCLUZE in combination with amivantamab (N=421) Osimertinib (N=428) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Skin and subcutaneous tissue disorders Rash Grouped terms 86 26 48 1.2 Nail toxicity 71 11 34 0.7 Dry skin 25 1 18 0.2 Pruritus 24 0.5 17 0.2 Injury, poisoning and procedural complications Infusion-related reaction Applicable only to amivantamab 63 6 0 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain 47 2.1 39 1.9 Gastrointestinal disorders Stomatitis 43 2.4 27 0.5 Diarrhea 31 2.6 45 0.9 Constipation 29 0 13 0 Nausea 21 1.2 14 0.2 Vomiting 12 0.5 5 0 Abdominal pain 11 0 10 0 Hemorrhoids 10 0.2 2.1 0.2 General disorders and administration site conditions Edema 43 2.6 8 0 Fatigue 32 3.8 20 1.9 Pyrexia 12 0 9 0 Vascular disorders Venous thromboembolism 36 11 8 2.8 Hemorrhage 25 1 13 1.2 Nervous system disorders Paresthesia 35 1.7 10 0.2 Dizziness 14 0 10 0 Headache 13 0.2 13 0 Infections and infestations COVID-19 26 1.7 24 1.4 Conjunctivitis 11 0.2 1.6 0 Metabolism and nutrition disorders Decreased appetite 24 1 18 1.4 Respiratory, thoracic and mediastinal disorders Cough 19 0 23 0 Dyspnea 14 1.7 17 3.5 Eye disorders Ocular toxicity 16 0.7 7 0 Psychiatric disorders Insomnia 10 0 11 0 Clinically relevant adverse reactions occurring in < 10% of patients who received LAZCLUZE in combination with amivantamab included skin ulcer (applicable to amivantamab) and ILD/pneumonitis. Table 4 summarizes the laboratory abnormalities in MARIPOSA. Table 4: Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with NSCLC with EGFR Exon 19 Deletion or Exon 21 L858R Substitution Mutations in MARIPOSA The denominator used to calculate the rate is the number of patients with a baseline value and at least one post-treatment value for the specific lab test. Laboratory Abnormality LAZCLUZE in combination with amivantamab (N=421) Osimertinib (N=428) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Chemistry Decreased albumin 89 8 22 0.2 Increased ALT 65 7 29 2.6 Increased AST 52 3.8 36 1.9 Increased alkaline phosphatase 45 0.5 15 0.5 Decreased calcium (corrected) 41 1.4 27 0.7 Increased GGT 39 2.6 24 1.9 Decreased sodium 38 7 35 5 Decreased potassium 30 5 15 1.2 Increased creatinine 26 0.7 35 0.7 Decreased magnesium 25 0.7 10 0.2 Increased magnesium 12 2.6 20 4.8 Hematology Decreased platelet count 52 0.7 57 1.4 Decreased hemoglobin 47 3.8 56 1.9 Decreased white blood cell 38 1.0 66 0.7 Decreased neutrophils 15 1.4 33 1.4

<table width="85%" ID="Table3"><caption>Table 3: Adverse Reactions (&#x2265; 10%) in Patients with NSCLC with Exon 19 Deletion or Exon 21 L858R Substitution Mutations in MARIPOSA</caption><col width="40%" align="left" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule">Adverse Reaction</th><th colspan="2" styleCode="Rrule" valign="bottom">LAZCLUZE in combination with amivantamab (N=421) </th><th colspan="2" styleCode="Rrule" valign="bottom">Osimertinib (N=428) </th></tr><tr><th styleCode="Lrule Rrule" valign="bottom"/><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grade 3 or 4 (%) </th><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grade 3 or 4 (%) </th></tr></thead><tbody><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Skin and subcutaneous tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Rash<footnote ID="tb3ft">Grouped terms </footnote></td><td styleCode="Rrule">86</td><td styleCode="Rrule">26</td><td styleCode="Rrule">48</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nail toxicity<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">71</td><td styleCode="Rrule">11</td><td styleCode="Rrule">34</td><td styleCode="Rrule">0.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dry skin<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">25</td><td styleCode="Rrule">1</td><td styleCode="Rrule">18</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pruritus</td><td styleCode="Rrule">24</td><td styleCode="Rrule">0.5</td><td styleCode="Rrule">17</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Injury, poisoning and procedural complications</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Infusion-related reaction<footnote ID="K2078">Applicable only to amivantamab</footnote></td><td styleCode="Rrule">63</td><td styleCode="Rrule">6</td><td styleCode="Rrule">0</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Musculoskeletal pain<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">47</td><td styleCode="Rrule">2.1</td><td styleCode="Rrule">39</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Stomatitis<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">43</td><td styleCode="Rrule">2.4</td><td styleCode="Rrule">27</td><td styleCode="Rrule">0.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Diarrhea<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">31</td><td styleCode="Rrule">2.6</td><td styleCode="Rrule">45</td><td styleCode="Rrule">0.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Constipation</td><td styleCode="Rrule">29</td><td styleCode="Rrule">0</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">21</td><td styleCode="Rrule">1.2</td><td styleCode="Rrule">14</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0.5</td><td styleCode="Rrule">5</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Abdominal pain<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hemorrhoids</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0.2</td><td styleCode="Rrule">2.1</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">General disorders and administration site conditions</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Edema<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">43</td><td styleCode="Rrule">2.6</td><td styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">32</td><td styleCode="Rrule">3.8</td><td styleCode="Rrule">20</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pyrexia</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0</td><td styleCode="Rrule">9</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Vascular disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Venous thromboembolism<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">36</td><td styleCode="Rrule">11</td><td styleCode="Rrule">8</td><td styleCode="Rrule">2.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hemorrhage<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">25</td><td styleCode="Rrule">1</td><td styleCode="Rrule">13</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Nervous system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Paresthesia<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">35</td><td styleCode="Rrule">1.7</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dizziness<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">13</td><td styleCode="Rrule">0.2</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Infections and infestations</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> COVID-19</td><td styleCode="Rrule">26</td><td styleCode="Rrule">1.7</td><td styleCode="Rrule">24</td><td styleCode="Rrule">1.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Conjunctivitis</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0.2</td><td styleCode="Rrule">1.6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Metabolism and nutrition disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">24</td><td styleCode="Rrule">1</td><td styleCode="Rrule">18</td><td styleCode="Rrule">1.4</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cough<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">19</td><td styleCode="Rrule">0</td><td styleCode="Rrule">23</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dyspnea<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">14</td><td styleCode="Rrule">1.7</td><td styleCode="Rrule">17</td><td styleCode="Rrule">3.5</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Eye disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Ocular toxicity<footnoteRef IDREF="tb3ft"/></td><td styleCode="Rrule">16</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">7</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Psychiatric disorders</content></td></tr><tr><td styleCode="Lrule Rrule"> Insomnia</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr></tbody></table>

<table width="85%" ID="Table4"><caption>Table 4: Select Laboratory Abnormalities (&#x2265; 20%) That Worsened from Baseline in Patients with NSCLC with EGFR Exon 19 Deletion or Exon 21 L858R Substitution Mutations in MARIPOSA<footnote ID="K2599">The denominator used to calculate the rate is the number of patients with a baseline value and at least one post-treatment value for the specific lab test.</footnote></caption><col width="40%" align="left" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule">Laboratory Abnormality</th><th colspan="2" styleCode="Rrule" valign="bottom">LAZCLUZE in combination with amivantamab (N=421) </th><th colspan="2" styleCode="Rrule" valign="bottom">Osimertinib (N=428) </th></tr><tr><th styleCode="Lrule Rrule" valign="bottom"/><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grade 3 or 4 (%) </th><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grade 3 or 4 (%) </th></tr></thead><tbody><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Chemistry</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased albumin</td><td styleCode="Rrule">89</td><td styleCode="Rrule">8</td><td styleCode="Rrule">22</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased ALT</td><td styleCode="Rrule">65</td><td styleCode="Rrule">7</td><td styleCode="Rrule">29</td><td styleCode="Rrule">2.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased AST</td><td styleCode="Rrule">52</td><td styleCode="Rrule">3.8</td><td styleCode="Rrule">36</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased alkaline phosphatase</td><td styleCode="Rrule">45</td><td styleCode="Rrule">0.5</td><td styleCode="Rrule">15</td><td styleCode="Rrule">0.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased calcium (corrected)</td><td styleCode="Rrule">41</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">27</td><td styleCode="Rrule">0.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased GGT</td><td styleCode="Rrule">39</td><td styleCode="Rrule">2.6</td><td styleCode="Rrule">24</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased sodium</td><td styleCode="Rrule">38</td><td styleCode="Rrule">7</td><td styleCode="Rrule">35</td><td styleCode="Rrule">5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased potassium</td><td styleCode="Rrule">30</td><td styleCode="Rrule">5</td><td styleCode="Rrule">15</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased creatinine</td><td styleCode="Rrule">26</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">35</td><td styleCode="Rrule">0.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased magnesium</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased magnesium</td><td styleCode="Rrule">12</td><td styleCode="Rrule">2.6</td><td styleCode="Rrule">20</td><td styleCode="Rrule">4.8</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Hematology</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased platelet count</td><td styleCode="Rrule">52</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">57</td><td styleCode="Rrule">1.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased hemoglobin</td><td styleCode="Rrule">47</td><td styleCode="Rrule">3.8</td><td styleCode="Rrule">56</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased white blood cell</td><td styleCode="Rrule">38</td><td styleCode="Rrule">1.0</td><td styleCode="Rrule">66</td><td styleCode="Rrule">0.7</td></tr><tr><td styleCode="Lrule Rrule"> Decreased neutrophils</td><td styleCode="Rrule">15</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">33</td><td styleCode="Rrule">1.4</td></tr></tbody></table>