Drug updated on 10/25/2024
Dosage Form | Injection (intravenous; 350 mg/7 mL [50 mg/mL]) |
Drug Class | EGF receptor-directed and MET receptor-directed antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test
- Indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor
- Indicated in in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test
- Indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
Latest News
Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- Amivantamab-containing regimens significantly improved PFS (Progression-Free Survival) compared to chemotherapy alone. One study reported hazard ratios (HR) for disease progression or death of 0.48 and 0.44 (P < 0.001), with median PFS of 6.3 and 8.3 months, respectively, compared to 4.2 months for chemotherapy alone. Another study reported a median PFS of 11.4 months for amivantamab-chemotherapy versus 6.7 months for chemotherapy alone (HR: 0.40, 95% CI (33% maturity): 0.30-0.53, P < 0.001).
- ORR (Overall Response Rate) was significantly higher in amivantamab-containing regimens. One study reported ORRs of 64% and 63% for amivantamab-chemotherapy combinations compared to 36% for chemotherapy alone (P < 0.001). Another found a response rate of 73% for amivantamab-chemotherapy compared to 47% for chemotherapy alone (rate ratio: 1.50, 95% CI: 1.32-1.68, P < 0.001).
- Amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy also prolonged intracranial PFS. One study reported median intracranial PFS of 12.5 and 12.8 months, respectively, compared to 8.3 months for chemotherapy alone. The HR for intracranial disease progression or death was 0.55 and 0.58, respectively.
- Hematologic and EGFR (Funded by Janssen Research and Development; PAPILLON ClinicalTrials.gov number, NCT04538664.)-related toxicities were predominant in amivantamab-containing regimens. In one study, the amivantamab-lazertinib-chemotherapy group had higher hematologic adverse events (AEs) than the amivantamab-chemotherapy group, but both groups experienced significant toxicities. Another study reported that 7% of patients discontinued amivantamab due to adverse reactions, with reversible hematologic and EGFR-related toxicities being the most common.
- Amivantamab-containing regimens had more toxicities compared to chemotherapy alone. Specifically, one study highlighted that significant hematologic toxicities in the amivantamab-lazertinib-chemotherapy group necessitated a regimen change.
- One study included patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) (exon 19 deletions or L858R). Consistent progression-free survival (PFS) outcomes were observed in patients with a history of brain metastases and prior brain radiation. Another study focused on patients with advanced NSCLC harboring EGFR exon 20 insertions, who had not received prior systemic therapy. No specific subgroup findings were highlighted.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Rybrevant (amivantamab-vmjw) Prescribing Information. | 2024 | Janssen Biotech, Inc., Horsham, PA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study | 657Subjects F: 62% M: 38% | 2024 | Annals of Oncology |
Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions | 308Subjects F: 58% M: 42% | 2023 | The New England Journal of Medicine |
Sex Distribution:
F:62%
M:38%
657Subjects
Year:
2024
Source:Annals of Oncology
Sex Distribution:
F:58%
M:42%
308Subjects
Year:
2023
Source:The New England Journal of Medicine