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Efficacy and Safety Results of the Afatinib Expanded Access Program

Year: 2017

Type: article

Abstract: INTRODUCTION: ) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy. METHODS: mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug. RESULTS: Three hundred twenty-two patients received ≥1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with serious AEs. The most common afatinib-related AEs (all grades) were diarrhea (77.0%) and rash (36.0%). Dose reductions occurred in 31.1% of patients. Discontinuation rates due to diarrhea (1.6%) or rash/acne (0.3%) were low. Efficacy data were collected and analyzed when available, with 17.1% and 69.9% of patients achieving objective response and disease control, respectively, in this highly pretreated population. CONCLUSIONS: No additional or unexpected safety concerns were revealed, and afatinib demonstrated antitumor activity in a heavily pretreated NSCLC patient population in a routine clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01649284. FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc.

Source: Oncology and Therapy

DOI: 10.1007/s40487-017-0043-5