Clinical Scorecard: FDA approves amivantamab for head and neck cancer

At a Glance

Key Highlights

• The FDA granted accelerated approval to subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) as a single agent after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy.
• Approval was supported by the open-label, multicenter phase 1b/2 OrigAMI-4 trial of 102 previously treated patients.
• The overall response rate was 42%; reported responses included 15% complete responses and 28% partial responses. Among responders, 56% maintained response for at least 6 months.
• Serious treatment-emergent adverse events occurred in 39% of patients; fatal adverse reactions were reported in 6%.
• Accelerated approval was based on tumor response measures; continued approval may depend on verification of clinical benefit.

Guideline-Based Recommendations

Diagnosis

• The prescribing information excludes HPV-associated oropharyngeal squamous cell carcinoma, identified by p16 testing.

Management

• The prescribing information specifies single-agent use after platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 antibody in eligible adults with recurrent or metastatic HNSCC.
• In OrigAMI-4, patients received weight-based subcutaneous treatment every 3 weeks until disease progression or unacceptable toxicity.
• Known hypersensitivity to hyaluronidase or its excipients is a contraindication.

Monitoring & Follow-up

• The prescribing information warns of hypersensitivity and administration-related reactions, interstitial lung disease/pneumonitis, dermatologic reactions, ocular toxicity, and embryo-fetal toxicity.
• Reported adverse reactions included rash, fatigue, nail toxicity, stomatitis, and edema.

Risks

• Common adverse reactions included rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%), and edema (28%).
• Serious treatment-emergent adverse events were reported in 39% of patients, and fatal adverse reactions in 6%.

Patient & Prescribing Data

Adults with recurrent or metastatic HNSCC progressing on or after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy; the prescribing information excludes HPV-associated oropharyngeal squamous cell carcinoma identified by p16 testing.

Subcutaneous amivantamab and hyaluronidase-lpuj is given as a single agent. In OrigAMI-4, treatment was weight-based and administered every 3 weeks until progression or unacceptable toxicity.

Clinical Best Practices

• The prescribing information specifies prior platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy and excludes HPV-associated oropharyngeal disease identified by p16 testing.
• The prescribing information lists known hypersensitivity to hyaluronidase or its excipients as a contraindication.
• The prescribing information warns of hypersensitivity and administration-related reactions, pneumonitis, dermatologic and ocular toxicity, and embryo-fetal toxicity; reported adverse reactions included rash, fatigue, nail toxicity, stomatitis, and edema.
• The FDA's accelerated approval was based on tumor response measures rather than confirmed long-term clinical benefit.

Related Resources & Content

• FDA press release
• J&J press release
• J&J study summary
• Prescribing information