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Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after
Vishal Shah1, Andrea McNatty2, Lacey Simpson1
1Department of Pharmacy, Mayo Clinic, 5881 E Mayo Blvd, Phoenix, AZ 85054, USA.
Objective:
This study is a comprehensive review of the clinical pharmacology, pharmacokinetics, efficacy, safety, and clinical applicability of amivantamab-vmjw for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutation.
Data Synthesis:
The literature search to identify clinical trials returned only the CHRYSALIS phase 1 study. In a phase I trial, amivantamab-vmjw was associated with an overall response rate (ORR) of 40% (95% CI, 29-51) in the EGFR exon20ins NSCLC patient population (n = 81) after platinum-based chemotherapy. There were 3 complete responses (CRs) and 29 partial responses (PRs). The median duration of response (DOR) was 11.1 months (95% CI, 6.9-not reached; NR). The median progression-free survival (PFS) was 8.3 months (95% CI, 6.5-10.9), and overall survival (OS) was 22.8 months (95% CI, 14.6-NR).
Application To Clinical Practice:
This review summarizes the pharmacology, clinical evidence, and use of amivantamab-vmjw for patients with locally advanced or metastatic NSCLC with EGFR exon20ins mutation.
Conclusion:
The FDA approval of amivantamab-vmjw, the first bispecific antibody to target the exon20ins mutation, represents an important advancement in the treatment of patients with NSCLC with limited effective treatment options. The initial findings of the CHRYSALIS trial demonstrate an overall tumor response benefit with an acceptable safety profile.
Insights
Amivantamab-vmjw shows promise for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The bispecific antibody demonstrated a 40% overall response rate in a Phase 1 trial, offering a new treatment option.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations presents a therapeutic challenge.
- Limited effective treatment options exist for patients with advanced or metastatic NSCLC harboring this specific mutation.
Purpose of the Study:
- To conduct a comprehensive review of amivantamab-vmjw for metastatic NSCLC with EGFR exon 20 insertion mutations.
- To evaluate the clinical pharmacology, pharmacokinetics, efficacy, safety, and applicability of amivantamab-vmjw.
Main Methods:
- A literature search was performed to identify relevant clinical trials.
- The CHRYSALIS phase 1 study was the primary source of clinical data.
Main Results:
- Amivantamab-vmjw demonstrated an overall response rate (ORR) of 40% in patients with EGFR exon20ins NSCLC.
- Median duration of response (DOR) was 11.1 months, with median progression-free survival (PFS) of 8.3 months and overall survival (OS) of 22.8 months.
- The drug exhibited an acceptable safety profile.
Conclusions:
- Amivantamab-vmjw is the first bispecific antibody approved for EGFR exon 20 insertion mutations in NSCLC.
- Its approval marks a significant advancement, offering a new treatment avenue for patients with limited options.
- Initial data suggest a tumor response benefit and manageable safety profile.
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