In this article
- FDA Approves Amivantamab-vmjw with Carboplatin and Pemetrexed for Non-Small Cell Lung Cancer with EGFR Exon 19 Deletions or L858R Mutations
- MARIPOSA-2 Trial – Effectiveness and Safety of Amivantamab-vmjw in EGFR-Mutated NSCLC
- Adverse Effects and Recommended Dosage of Amivantamab-vmjw for NSCLC
- How CancerFax Helps
On September 19, 2024, the Food and Drug Administration sanctioned amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) in conjunction with carboplatin and pemetrexed for adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) exhibiting epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, whose condition has advanced following treatment with an EGFR tyrosine kinase inhibitor.
The efficacy was assessed in MARIPOSA-2 (NCT04988295), a randomized, open-label, multicenter trial involving 657 patients with locally advanced or metastatic NSCLC exhibiting EGFR exon 19 deletions or exon 21 L858R substitution mutations, who had tumor progression following treatment with osimertinib. Patients were randomized in a 1:2:2 ratio to receive amivantamab-vmjw in conjunction with carboplatin and pemetrexed (amivantamab + CP), carboplatin and pemetrexed (CP) alone, or amivantamab-vmjw as part of an alternative combination regimen.
The primary efficacy outcome measure was progression-free survival (PFS) evaluated by blinded independent central review (BICR) for the comparison of amivantamab + CP with CP. The overall response rate (ORR) as assessed by BICR and overall survival (OS) were major secondary outcome measures. The median progression-free survival (PFS) was 6.3 months (95% confidence interval: 5.6, 8.4) in the amivantamab plus chemotherapy (CP) group and 4.2 months (95% confidence interval: 4.0, 4.4) in the chemotherapy group (hazard ratio 0.48 [95% confidence interval: 0.36, 0.64], p-value < 0.0001). The confirmed overall response rate (ORR) was 53% (95% confidence interval: 44, 62) in the amivantamab plus chemotherapy arm and 29% (95% confidence interval: 23, 35) in the chemotherapy arm (p-value < 0.0001).
At the predetermined second intermediate analysis of overall survival (OS), with 85% of the requisite deaths for the final analysis, no statistically significant difference in OS was observed. The stratified overall survival hazard ratio was 0.73 (95% confidence interval: 0.54, 0.99).
The predominant adverse responses (≥20%) included rash, infusion-related symptoms, exhaustion, nail toxicity, nausea, constipation, edema, stomatitis, diminished appetite, musculoskeletal discomfort, vomiting, and COVID-19 infection.
The prescribed dosage of amivantamab-vmjw is determined by initial body weight. Refer to the prescription instructions for detailed dose guidelines.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Sai Sree
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.