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Efficacy and Safety Results of the Afatinib Expanded Access Program
Edward S Kim1, Balazs Halmos2, Ingrid F Kohut3
1Department of Solid Tumor Oncology and Investigational Therapeutics, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC USA.
Oncology and Therapy
|July 7, 2017
Summary
Afatinib, an EGFR inhibitor, showed antitumor activity in pretreated metastatic NSCLC patients via an expanded access program. Safety was consistent with known profiles, with low discontinuation rates for common adverse events.
Area of Science:
- Oncology
- Pharmacology
Background:
- Afatinib is an approved oral, irreversible ErbB family blocker for EGFR mutation-positive metastatic non-small cell lung cancer (NSCLC).
- An expanded access program (EAP) provided early afatinib access and collected real-world data on safety and efficacy.
Purpose of the Study:
- To evaluate the safety, tolerability, and efficacy of afatinib in a large, heavily pretreated NSCLC patient population.
- To gather additional data on afatinib's performance in a routine clinical setting.
Main Methods:
- An open-label, multicenter, single-arm EAP in the US involving 322 patients with advanced or metastatic NSCLC and EGFR mutations.
- Afatinib 40 mg was administered orally once daily until disease progression, adverse events, or transition to commercial supply.
Main Results:
- 89.4% of patients experienced drug-related adverse events (AEs), most commonly diarrhea (77.0%) and rash (36.0%).
- Serious AEs occurred in 7.8% of patients; dose reductions were needed for 31.1%.
- Low discontinuation rates (1.6% for diarrhea, 0.3% for rash/acne) were observed. Objective response and disease control rates were 17.1% and 69.9%, respectively.
Conclusions:
- Afatinib demonstrated antitumor activity in a heavily pretreated NSCLC population within a routine clinical setting.
- The EAP did not reveal new or unexpected safety concerns, aligning with established afatinib safety profiles.
