RYBREVANT®

(amivantamab-vmjw)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

RYBREVANT® (amivantamab-vmjw)

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RYBREVANT - Dosage and Administration

Last Updated: 10/10/2024

SUMMARY

RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹
LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor (TKI).²
The dosage and administration information summarized below is for RYBREVANT use in patients with locally advanced or metastatic NSCLC and predefined EGFR mutations.
The recommended dosage of RYBREVANT is based on baseline body weight and administered as an intravenous (IV) infusion after dilution. The dosage of RYBREVANT is provided in the Table: Recommended Dosage Schedule for RYBREVANT in Combination with Carboplatin and Pemetrexed and Table: Recommended Dosage Schedule for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent.³
- Administer premedications as recommended in the Table: Premedications.
- Administer RYBREVANT in combination with chemotherapy weekly (QW) for 4 weeks, with the initial RYBREVANT dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 3 weeks (Q3W) starting at Week 7.
- Administer RYBREVANT in combination with lazertinib or RYBREVANT as a single agent QW for 5 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 2 weeks (Q2W) starting at Week 7.
Administer RYBREVANT via a peripheral line on Week 1 Day 1 and Day 2 and Week 2 to reduce the risk of infusion-related reactions (IRRs) during initial treatment. Administer diluted RYBREVANT IV according to the infusion rates in the Table: Infusion Rates for RYBREVANT in Combination with Carboplatin and Pemetrexed and Table: Infusion Rates for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent.³
- Monitor patients for any signs and symptoms of IRRs during RYBREVANT infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity.
Modify RYBREVANT dosing for adverse reactions (ARs) as described in the Table: Recommended RYBREVANT Dose Reductions for ARs and in the Table: Recommended RYBREVANT Dosage Modifications and Management for ARs.³
Consider the following relevant topics of information when administering RYBREVANT:
- Infusion-related Reactions
- Dermatologic Adverse Reactions
- Venous thromboembolism (when RYBREVANT is given in combination with lazertinib)
- Interstitial Lung Disease/Pneumonitis
Please refer to the DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, WARNINGS AND PRECAUTIONS, and CLINICAL STUDIES sections of the full Prescribing Information for complete information.³

PRODUCT LABELING

RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf.
LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf.

DOSAGE AND ADMINISTRATION

Important Dosage Information

Administer premedications before each RYBREVANT infusion as recommended (Table: Premedications).³

Administer diluted RYBREVANT IV according to the infusion rates in the Table: Infusion Rates for RYBREVANT in Combination with Carboplatin and Pemetrexed and Table: Infusion Rates for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2.³

Administer RYBREVANT via peripheral line for Week 1 Day 1 and Day 2 and Week 2 to reduce the risk of IRRs.³

When administering RYBREVANT in combination with carboplatin and pemetrexed, infuse pemetrexed first, carboplatin second, and RYBREVANT last.³

When administering RYBREVANT in combination with lazertinib, administer lazertinib orally any time before the RYBREVANT infusion.³

When administering RYBREVANT in combination with lazertinib, administer anticoagulant prophylaxis to prevent venous thromboembolic (VTE) events for the first 4 months of treatment.³

Patient Selection

Select patients for treatment with RYBREVANT based on the presence of a mutation as detected by a United States (US) Food and Drug Administration (FDA)-approved test (see table below). Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.³

Patient Selection³

Indication	Treatment Regimen	Source for Testing
First-line treatment of NSCLC with EGFR Exon19del or Exon 21 L858R substitution mutations	RYBREVANT in combination with lazertinib	Tumor or plasma specimens. Testing may be performed at any time from initial diagnosis. Testing does not need to be repeated once EGFR mutation status has been established.
Previously treated locally advanced or metastatic NSCLC with EGFR Exon19del or Exon 21 L858R substitution mutations (progressive disease on an EGFR tyrosine kinase inhibitor)	RYBREVANT in combination with carboplatin and pemetrexed
First-line treatment of NSCLC with EGFR Exon20ins mutations	RYBREVANT in combination with carboplatin and pemetrexed
Previously treated NSCLC with EGFR Exon20ins mutations	RYBREVANT as a single agent
Abbreviations: EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; Exon20ins, Exon 20 insertion; NSCLC, non-small cell lung cancer.

Recommended Dosage of RYBREVANT in Combination with Carboplatin and Pemetrexed for the Treatment of NSCLC - Q3W Dosing

The recommended dosages of RYBREVANT, administered in combination with carboplatin and pemetrexed, based on baseline body weight are provided in the table below.³

Recommended Dosage Schedule for RYBREVANT in Combination with Carboplatin and Pemetrexed³

Body Weight at Baseline^a	Recommended Dose	Dosing Schedule
<80 kg	1400 mg	Weekly (total of 4 doses) from Weeks 1 to 4. Week 1 - split infusion on Day 1 and Day 2. Weeks 2 to 4 - infusion on Day 1. Weeks 5 and 6 - no dose.
<80 kg	1750 mg	Q3W starting at Week 7 onwards.
≥80 kg	1750 mg	Weekly (total of 4 doses) from Weeks 1 to 4. Week 1 - split infusion on Day 1 and Day 2. Weeks 2 to 4 - infusion on Day 1. Weeks 5 and 6 - no dose.
≥80 kg	2100 mg	Q3W starting at Week 7 onwards.
Abbreviation: Q3W, every 3 weeks.^aDose adjustments not required for subsequent body weight changes.

The recommended order of administration and regimen for RYBREVANT in combination with carboplatin and pemetrexed is provided in the table below.³

Order of Administration and Regimen for RYBREVANT in Combination with Carboplatin and Pemetrexed³

Administer the regimen in the following order: pemetrexed first, carboplatin second, and RYBREVANT last.
Drug	Dose	Duration/Timing of Treatment
Pemetrexed	Pemetrexed 500 mg/m²IV. Refer to the pemetrexed Full PI for complete information.	Q3W, continue until disease progression or unacceptable toxicity.
Carboplatin	Carboplatin AUC 5 IV. Refer to the carboplatin Full PI for complete information.	Q3W for up to 12 weeks.
RYBREVANT	RYBREVANT IV. See Table: Recommended Dosage Schedule for RYBREVANT in Combination with Carboplatin and Pemetrexed.	Q3W, continue until disease progression or unacceptable toxicity.
Abbreviations: AUC, area under curve; IV, intravenous; PI, Prescribing Information; Q3W, every 3 weeks.

Recommended Dosage of RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent for the Treatment of NSCLC – Q2W Dosing

The recommended dosages of RYBREVANT in combination with lazertinib or RYBREVANT as a single agent, based on baseline body weight, are provided in the table below.³

Recommended Dosage Schedule for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent³

Body Weight at Baseline^a	Recommended Dose	Dosing Schedule
<80 kg	1050 mg	Weekly (total of 5 doses) from Weeks 1 to 5. Week 1 - split infusion on Day 1 and Day 2. Weeks 2 to 5 - infusion on Day 1. Week 6 - no dose.
<80 kg	1050 mg	Q2W starting at Week 7 onwards.
≥80 kg	1400 mg	Weekly (total of 5 doses) from Weeks 1 to 5. Week 1 - split infusion on Day 1 and Day 2. Weeks 2 to 5 - infusion on Day 1. Week 6 - no dose.
≥80 kg	1400 mg	Q2W starting at Week 7 onwards.
Abbreviation: Q2W, every 2 weeks.^aDose adjustments not required for subsequent body weight changes.

Administer RYBREVANT until disease progression or unacceptable toxicity.³

RYBREVANT in Combination with Lazertinib

Order of Administration

When given in combination with lazertinib, administer RYBREVANT any time after lazertinib when given on the same day. Refer to the lazertinib Prescribing Information for recommended lazertinib dosing information. Administer RYBREVANT in combination with lazertinib until disease progression or unacceptable toxicity.³

Concomitant Medications

When initiating treatment with RYBREVANT in combination with lazertinib, administer anticoagulant prophylaxis to prevent VTE events for the first 4 months of treatment. If there are no signs or symptoms of VTE events during the first 4 months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider. Refer to the lazertinib Prescribing Information for information about concomitant medications.³

When initiating treatment with RYBREVANT in combination with lazertinib, administer alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream and encourage patients to limit sun exposure during and for 2 months after treatment, to wear protective clothing, and to use broad-spectrum ultraviolet (UV)-A/B sunscreen to reduce the risk of dermatologic ARs. Consider prophylactic measures (eg, use of oral antibiotics) to reduce the risk of dermatologic ARs. Refer to the lazertinib Prescribing Information for information about concomitant medications.³

Recommended Premedications

Prior to the initial infusion of RYBREVANT (Week 1, Day 1 and Day 2), administer premedication as described in the table below to reduce the risk of IRRs. Refer to Prescribing Information Section 5.1 WARNINGS AND PRECAUTIONS for additional information.³

Glucocorticoid administration is required for Week 1, Day 1 and Day 2 dose only and upon re‑initiation after prolonged dose interruptions, then as necessary for subsequent infusions (see table below). Administer both antihistamine and antipyretic prior to all infusions.³

Premedications³

Medication	Dose	Route of Administration	Dosing Window Prior to RYBREVANT Administration
Antihistamine^a	Diphenhydramine (25-50 mg) or equivalent	IV	15-30 minutes
Antihistamine^a	Diphenhydramine (25-50 mg) or equivalent	Oral	30-60 minutes
Antipyretic^a	Acetaminophen (650-1000 mg)	IV	15-30 minutes
Antipyretic^a	Acetaminophen (650-1000 mg)	Oral	30-60 minutes
Glucocorticoid^b	Dexamethasone (20 mg) or equivalent	IV	45-60 minutes
Glucocorticoid^c	Dexamethasone (10 mg) or equivalent	IV	45-60 minutes
Abbreviation: IV, intravenous.^aRequired at all doses. ^bRequired at initial dose (Week 1 Day 1). ^cRequired at second dose (Week 1 Day 2); optional for subsequent doses.

Dosage Modifications for ARs

The recommended RYBREVANT dose reductions for ARs are listed in the table below.³

RYBREVANT Dose Reductions for ARs³

Dose^a	1^st Dose Reduction	2^nd Dose Reduction	3^rd Dose Reduction
1050 mg	700 mg	350 mg	Discontinue RYBREVANT
1400 mg	1050 mg	700 mg
1750 mg	1400 mg	1050 mg
2100 mg	1750 mg	1400 mg
Abbreviation: AR, adverse reaction.^aDose at which the AR occurred.

The recommended RYBREVANT dosage modifications and management for ARs are provided in the table below.³

Recommended RYBREVANT Dosage Modifications and Management for ARs³

AR	Severity	Dosage Modifications
IRR	Grade 1-2	Interrupt RYBREVANT infusion if IRR is suspected and monitor patient until reaction symptoms resolve. Resume the infusion at 50% of the infusion rate at which the reaction occurred. If there are no additional symptoms after 30 minutes, the infusion rate may be escalated (see Table: Infusion Rates for RYBREVANT in Combination with Carboplatin and Pemetrexed and Table: Infusion Rates for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent). Include corticosteroid with premedications for subsequent dose (see Table: Premedications).
	Grade 3	Interrupt RYBREVANT infusion and administer supportive care medications. Continuously monitor patient until reaction symptoms resolve. Resume the infusion at 50% of the infusion rate at which the reaction occurred. If there are no additional symptoms after 30 minutes, the infusion rate may be escalated (see Table: Infusion Rates for RYBREVANT in Combination with Carboplatin and Pemetrexed and Table: Infusion Rates for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent). Include corticosteroid with premedications for subsequent dose (see Table: Premedications). For recurrent grade 3 reactions, permanently discontinue RYBREVANT.
	Grade 4	Permanently discontinue RYBREVANT.
ILD/pneumonitis	Any grade	Withhold RYBREVANT if ILD/pneumonitis is suspected. Permanently discontinue RYBREVANT if ILD/pneumonitis is confirmed.
VTE events	Grade 2 or 3	Withhold RYBREVANT and lazertinib. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, resume RYBREVANT and lazertinib at the same dose level, at the discretion of the healthcare provider.
VTE events	Grade 4 or recurrent grade 2 or 3 despite therapeutic level anticoagulation	Withhold lazertinib and permanently discontinue RYBREVANT. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, treatment with lazertinib can continue at the same dose level, at the discretion of the healthcare provider.
Dermatologic ARs (including dermatitis acneiform, pruritus, dry skin)	Grade 1 or 2	Initiate supportive care management. Reassess after 2 weeks; if rash does not improve, consider dose reduction.
	Grade 3	Withhold RYBREVANT and initiate supportive care management. Upon recovery to grade ≤2, resume RYBREVANT at reduced dose. If no improvement within 2 weeks, permanently discontinue treatment.
	Grade 4	Permanently discontinue RYBREVANT.
	Severe bullous, blistering or exfoliating skin conditions (including TEN)	Permanently discontinue RYBREVANT.
Other ARs	Grade 3	Withhold RYBREVANT until recovery to grade ≤1 or baseline. Resume at the same dose if recovery occurs within 1 week. Resume at reduced dose if recovery occurs after 1 week but within 4 weeks. Permanently discontinue if recovery does not occur within 4 weeks.
Other ARs	Grade 4	Withhold RYBREVANT until recovery to grade ≤1 or baseline. Resume at reduced dose if recovery occurs within 4 weeks. Permanently discontinue if recovery does not occur within 4 weeks. Permanently discontinue for recurrent grade 4 reactions.
Abbreviations: AR, adverse reaction; ILD, interstitial lung disease; IRR, infusion-related reaction; TEN, toxic epidermal necrolysis; VTE, venous thromboembolic.

Recommended Dosage Modifications for ARs for RYBREVANT in Combination with Lazertinib

When administering RYBREVANT in combination with lazertinib, if there is an AR requiring dose reduction after withholding treatment and resolution, reduce the dose of RYBREVANT first. Refer to the lazertinib Prescribing Information for information about dosage modifications for lazertinib.³

Recommended Dosage Modifications for ARs for RYBREVANT in Combination with Carboplatin and Pemetrexed

When administering RYBREVANT in combination with carboplatin and pemetrexed, modify the dosage of one or more drugs. Withhold or discontinue RYBREVANT as shown in Table: Recommended RYBREVANT Dosage Modifications and Management for ARs. Refer to Prescribing Information for carboplatin and pemetrexed for additional dosage modification information.³

Preparation

RYBREVANT is available as a 350 mg/7 mL (50 mg/mL) solution in a single-dose vial. Dilute and prepare RYBREVANT for IV infusion before administration.³

Check that the RYBREVANT solution is colorless to pale yellow. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present.³
Determine the dose required and number of RYBREVANT vials needed based on patient’s baseline weight. Each vial of RYBREVANT contains 350 mg of amivantamabvmjw.³
Withdraw and then discard a volume of either 5% dextrose solution or 0.9% sodium chloride solution from the 250 mL infusion bag equal to the volume of RYBREVANT to be added (ie, discard 7 mL diluent from the infusion bag for each RYBREVANT vial). Only use infusion bags made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE).³
Withdraw 7 mL of RYBREVANT from each vial and add it to the infusion bag. The final volume in the infusion bag should be 250 mL. Discard any unused portion left in the vial.
Gently invert the bag to mix the solution. Do not shake.³
Diluted solutions should be administered within 10 hours (including infusion time) at room temperature 59°F to 77°F (15°C to 25°C).³

Administration

Administer the diluted RYBREVANT solution by IV infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.2 micrometer).³
Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE.³
The administration set with filter, must be primed with either 5% dextrose solution or 0.9% sodium chloride solution prior to the initiation of each RYBREVANT infusion.³
Do not infuse RYBREVANT concomitantly in the same IV line with other agents.³

RYBREVANT in Combination with Carboplatin and Pemetrexed

Administer RYBREVANT in combination with carboplatin and pemetrexed infusions Q3W IV until disease progression or unacceptable toxicity according to the infusion rates in the table below.³
Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs during initial treatment.³
RYBREVANT may be administered via central line for subsequent weeks.³
For the initial infusion, prepare RYBREVANT as close to administration time as possible to allow for the possibility of extended infusion time in the event of an IRR.³
Administer the pemetrexed infusion first, carboplatin infusion second, and the RYBREVANT infusion last.³

Infusion Rates for RYBREVANT in Combination with Carboplatin and Pemetrexed³

Body Weight <80 kg
Week	Dose (per 250 mL Bag)	Initial Infusion Rate	Subsequent Infusion Rate^a
Week 1 (split dose infusion)
Week 1 Day 1	350 mg	50 mL/hr	75 mL/hr
Week 1 Day 2	1050 mg	33 mL/hr	50 mL/hr
Week 2	1400 mg	65 mL/hr
Week 3	1400 mg	85 mL/hr
Week 4	1400 mg	125 mL/hr
Weeks 5 and 6	No dose
Week 7 and Q3W thereafter	1750 mg	125 mL/hr
Body Weight ≥80 kg
Week	Dose (per 250 mL Bag)	Initial Infusion Rate	Subsequent Infusion Rate^a
Week 1 (split dose infusion)
Week 1 Day 1	350 mg	50 mL/hr	75 mL/hr
Week 1 Day 2	1400 mg	25 mL/hr	50 mL/hr
Week 2	1750 mg	65 mL/hr
Week 3	1750 mg	85 mL/hr
Week 4	1750 mg	125 mL/hr
Weeks 5 and 6	No dose
Week 7 and Q3W thereafter	2100 mg	125 mL/hr
Abbreviation: IRR, infusion-related reaction.^aIn the absence of IRRs, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4-6 hours for Day 1 and 6-8 hours for Day 2. Subsequent infusion time is approximately 2 hours.

RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent

Administer RYBREVANT as a single agent infusion Q2W IV until disease progression or unacceptable toxicity according to the infusion rates in the table below.³
Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs during initial treatment.³
RYBREVANT may be administered via central line for subsequent weeks.³
For the initial infusion, prepare RYBREVANT as close to administration time as possible to allow for the possibility of extended infusion time in the event of an IRR.³
When given in combination with lazertinib, administer RYBREVANT any time after lazertinib when given on the same day.³

Infusion Rates for RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent³

Body Weight <80 kg
Week	Dose (per 250 mL Bag)	Initial Infusion Rate	Subsequent Infusion Rate^a
Week 1 (split dose infusion)
Week 1 Day 1	350 mg	50 mL/hr	75 mL/hr
Week 1 Day 2	700 mg	50 mL/hr	75 mL/hr
Week 2	1050 mg	85 mL/hr
Week 3	1050 mg	125 mL/hr
Week 4	1050 mg	125 mL/hr
Week 5	1050 mg	125 mL/hr
Week 6	No dose
Week 7 and Q2W thereafter	1050 mg	125 mL/hr
Body Weight ≥80 kg
Week	Dose (per 250 mL Bag)	Initial Infusion Rate	Subsequent Infusion Rate^a
Week 1 (split dose infusion)
Week 1 Day 1	350 mg	50 mL/hr	75 mL/hr
Week 1 Day 2	1050 mg	35 mL/hr	50 mL/hr
Week 2	1400 mg	65 mL/hr
Week 3	1400 mg	85 mL/hr
Week 4	1400 mg	125 mL/hr
Week 5	1400 mg	125 mL/hr
Week 6	No dose
Week 7 and Q2W thereafter	1400 mg	125 mL/hr
Abbreviation: IRR, infusion-related reaction. ^aIn the absence of IRRs, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4-6 hours for Day 1 and 6-8 hours for Day 2. Subsequent infusion time is approximately 2 hours.

Dosing Schedule from the PAPILLON and MARIPOSA-2 Studies³^-⁵

Abbreviations: AUC, area under curve; D, day; Q3W, every 3 weeks.

The recommended dosages of RYBREVANT, administered in combination with carboplatin and pemetrexed, based on baseline body weight are provided in the table above.

Dosing Schedule from the MARIPOSA Study³^,⁶

Abbreviations: D, day; QD, once daily.

The recommended dosages of RYBREVANT in combination with lazertinib, based on baseline body weight, are provided in the table above.

Dosing Schedule from the CHRYSALIS Study³^,⁷

Abbreviation: D, day.

The recommended dosages of RYBREVANT as a single agent, based on baseline body weight, are provided in the table above.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 August 2024.

References

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1	Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.
2	Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small cell lung cancer. Future Oncol. 2022;18(6):639-647.
3	RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf.
4	Zhou C, Tang KJ, Cho BC, et al. Clinical Protocol for: Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051.
5	Passaro A, Wang J, Wang Y, et al. Clinical Protocol for: Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase 3 MARIPOSA-2 study. Ann Oncol. 2024;35(1):77-90.
6	Cho BC, Lu S, Felip E, et al. Clinical Protocol for: Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. [published online ahead of print June 26, 2024]. N Engl J Med. doi:10.1056/nejmoa2403614.
7	Park K, Haura EB, Leighl NB, et al. Clinical Protocol for: Amivantamab in EGFR exon 20 insertion-mutated non-small cell lung cancer progressing on platinum chemotherapy: initial results from the CHRYSALIS phase I study. J Clin Oncol. 2021;39(30):3391-3402.