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A. Morabito



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    OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA23.03 - Second-Line Afatinib for Advanced Squamous Cell Carcinoma of the Lung: Analysis of Afatinib Long-Term Responders in the Phase III LUX-Lung 8 Trial (ID 4711)

      14:40 - 14:50  |  Author(s): A. Morabito

      • Abstract
      • Presentation
      • Slides

      Background:
      Squamous cell carcinoma (SCC) of the lung is a genetically complex and difficult-to-treat cancer. In LUX-Lung 8, afatinib (40mg/day) significantly improved OS (median 7.9 vs 6.8 months, HR=0.81 [95% CI, 0.69‒0.95], p=0.008), PFS (2.6 vs 1.9 months, HR=0.81 [0.69‒0.96], p=0.010) and DCR versus erlotinib (150mg/day) in patients with relapsed/refractory SCC of the lung (n=795). Notably, 12-month (36 vs 28%; p=0.016) and 18-month survival (22 vs 14%; p=0.016) was significantly higher with afatinib than erlotinib, indicating that some patients derive prolonged benefit from afatinib. Here, we present post-hoc analysis of baseline characteristics and efficacy/safety of afatinib in long-term responders (treatment for ≥12 months). Hypothesis-generating analysis of archived tumor samples and blood serum was undertaken to identify possible molecular/clinical biomarkers.

      Methods:
      Tumor samples were retrospectively analyzed using FoundationOne[TM] next-generation sequencing (NGS); EGFR expression was determined by immunohistochemistry. Pre-treatment serum samples were analyzed with VeriStrat[®], a MALDI-TOF mass spectrometry test, and classified as VeriStrat-Good or VeriStrat-Poor-risk.

      Results:
      15/398 patients treated with afatinib were long-term responders. Median duration of treatment was 16.6 months (range: 12.3‒25.8). Patient characteristics were similar to the overall dataset (median age: 65 years [range: 54‒81]; male: 80.0%; Asian: 13.3%; ECOG 0/1: 40.0%/60.0%; best response to chemotherapy CR or PR/SD: 53.3%/46.7%; current and ex-smokers: 80.0%). Median PFS was 16.2 months (range: 2.8‒24.0); median OS was 23.1 months (range: 12.9‒31.5). The most common treatment-related AEs (all grade/grade 3) were: diarrhea (73.3%/6.7%); rash/acne (66.7%/6.7%); stomatitis (13%/7%). AEs generally occurred soon after treatment onset (median onset, days [range]: diarrhea 11 [5‒48]; rash/acne 17 [9‒107]; stomatitis 15 [11‒19]). Four patients required a dose reduction to 30mg/day due to treatment-related AEs (diarrhea, rash, stomatitis, diarrhea/rash). NGS was undertaken in 9 patients and details will be presented at the meeting. Genomic aberrations in the ErbB/FGF gene families were identified in 44.4%/55.6% of long-term responders (overall dataset: 29.4%/58.0%). Of 14 patients assessed by VeriStrat, 85.7% were VeriStrat-Good (overall dataset: 61.6%). Immunohistochemistry data was available for two patients; one overexpressed EGFR (≥10% positive cells; H-score ≥200)

      Conclusion:
      Baseline characteristics of long-term responders to afatinib were similar to the overall dataset. In this sub-group, afatinib conferred a survival benefit of nearly 2 years. Afatinib was well tolerated with predictable and transient AEs that occurred soon after treatment onset. The dataset was too small to identify any clear NGS/VeriStrat predictive signals. Further studies are required to predict long-term response to afatinib.

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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-095 - Italian Nivolumab Expanded Access Programme: Efficacy and Safety Data in Squamous Non Small Cell Lung Cancer Patients (ID 5159)

      14:30 - 14:30  |  Author(s): A. Morabito

      • Abstract

      Background:
      Nivolumab monotherapy has shown survival benefit in patients (pts) with melanoma, lung cancer, renal cell carcinoma and head and neck cancer. The experience of pts and physicians in routine clinical practice is often different from those in a controlled clinical trial setting. Here, we report efficacy and safety of nivolumab monotherapy in pts with squamous non small cell lung cancer (Sq-NCSLC) treated in the nivolumab Expanded Access Programme in Italy.

      Methods:
      Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg wass administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events.

      Results:
      In total, 371 Italian pts participated in the EAP across 96 centres and 363 patients were evaluable for response. With a median follow-up of 5.2 months (range 0-12.9) and a median of 7 doses, the best overall response rate (BORR) was 18%, with 3 complete responses (CR) and 62 partial responses (PR), and the disease control rate (DCR) was 47%. DCR was comparable among pts regardless previous lines of therapy, brain metastasis, age and smoking habits. A non-conventional benefit was observed in 23 (17 SD and 6 PR) out of 66 pts treated beyond RECIST defined progression. As of April 2016, median progression-free survival and median overall survival were 3.9 (95% CI: 3.2-4.6) and 9.1 (95% CI: 6.7-11.5) months, respectively. Regarding the safety profile, 267 out of 371 pts (72%) had at least one AE of any grade, considered to be drug-related in 106 pts (29%). Grade 3/4 AE were reported in 66 pts and considered to be drug-related in 20 pts (5%). AE were generally manageable following the specific guidelines.

      Conclusion:
      To date, this is the largest clinical experience with nivolumab in a real-world setting. These preliminary EAP data seems to confirm the efficacy and safety data of nivolumab from registrational trials, supporting its use in current clinical practice for pre-treated pts with Sq-NCSLC.