Recent Clinical Trial Highlights for NSCLC Treatment

EP: 1.Overcoming Challenges in NSCLC Management From a Pharmacist’s Perspective

EP: 2.First-Line Focus: Molecular Testing and Guideline-Directed Therapy in EGFR-Positive NSCLC

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EP: 3.Recent Clinical Trial Highlights for NSCLC Treatment

EP: 4.Integrating Clinical Trial Findings Into Everyday Pharmacy Practice

First-Line and Second-Line Treatment Options for EGFR-Positive NSCLC: Recent Clinical Trials

Evolution of Treatment Options

Recent clinical trials have significantly expanded treatment options for patients with EGFR-positive NSCLC, offering choices between:

• Single-agent oral therapy
• Escalation with chemotherapy combinations
• Intravenous and oral combination therapy (amivantamab plus lazertinib)

Key First-Line Clinical Trials

FLAURA2 Trial: Osimertinib Plus Chemotherapy vs Osimertinib Alone

• Efficacy findings:
  • Significantly longer progression-free survival (PFS) with combination therapy
  • Trending toward improved overall survival (data still immature)
  • Improved response rates and duration of response
  • Major PFS improvements for patients with baseline central nervous system metastases
• Safety profile:
  • No new safety signals
  • Toxicities consistent with individual agents' known profiles

MARIPOSA Trial: Amivantamab Plus Lazertinib vs Osimertinib vs Lazertinib Alone

• Efficacy findings:
  • Significantly longer PFS with amivantamab plus lazertinib combination
  • First regimen to show significantly longer overall survival compared with osimertinib
  • Similar response rates to osimertinib but improved duration of response
• Safety profile:
  • Higher rates of treatment discontinuation with combination therapy
  • Increased incidence of infusion-related reactions, venous thromboembolism, and significant dermatologic and ocular toxicities compared with osimertinib alone

Second-Line Treatment Option

MARIPOSA-2 Trial: Post-Osimertinib Progression Setting

• Study arms:
  • Amivantamab plus chemotherapy
  • Amivantamab plus lazertinib plus chemotherapy
  • Chemotherapy alone
• Efficacy findings:
  • Both amivantamab-containing regimens showed significantly longer PFS, higher response rates, and improved intracranial response vs chemotherapy alone
  • Similar intracranial response between the 2 amivantamab arms
• Safety profile:
  • Amivantamab-containing regimens had higher rates of dose interruptions, reductions, and discontinuations
  • Increased infusion-related reactions, dermatologic effects (including stomatitis and paronychia), and worse hematologic toxicities

Treatment for EGFR Exon 20 Insertion Mutations

PAPILLON Trial: First-Line Setting for Exon 20 Mutations

• Study arms:
  • Amivantamab plus chemotherapy
  • Chemotherapy alone
• Efficacy findings:
  • Improved PFS with the combination regimen
  • Overall survival data not mature at time of publication
• Safety profile:
  • Significant EGFR-related toxicities with combination therapy:
  • Dermatologic reactions
  • Ocular adverse effects
  • Infusion-related reactions
  • Higher incidence of hematologic toxicities