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D. Hao

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    P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P1.01-064 - A Phase II Study of Gemcitabine-Cisplatin plus Necitumumab for Stage IV Sq-NSCLC (ID 927)

      09:30 - 17:00  |  Author(s): D. Hao

      • Abstract
      • Slides

      To report the efficacy and safety results from a study of necitumumab (N), manufactured under process D, modified from Process C, used in the pivotal SQUIRE study, in combination with gemcitabine (G) plus cisplatin (C) as first-line treatment in patients with advanced squamous non-small cell lung cancer (Sq-NSCLC). (NCT01788566)

      This was an open-label, single-arm, multicenter, phase II study in patients with advanced Sq-NSCLC. Patients were enrolled who were aged ≥18 years and had measurable, pathologically confirmed stage IV Sq-NSCLC without prior chemotherapy. Patients had ECOG-PS 0-1, adequate organ function, and life expectancy of ≥12 weeks. Patients received N (800 mg iv, Days 1 and 8) plus GC (G=1250 mg/m² iv, Days 1 and 8; C=75 mg/m² iv, Day 1) each 3-week cycle for up to 6 cycles. Patients with at least stable disease (SD) could continue to receive N alone until progressive disease (PD) or other discontinuation criteria. Primary endpoint was objective response rate (ORR) based on RECIST1.1. Secondary endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), change in tumor size (CTS; % improvement in lesions), and safety.

      Patients (N=61), median age 65 years, heavy metastatic disease burden; approximately 70% of the patients had metastases to ≥ 2 organ systems. Efficacy results, including an ORR of 48.1% are shown in the Table. Survival and PFS findings were similar to those reported in the SQUIRE study in the GC+N arm (SQUIRE results: median OS of 11.5 months, 1-year survival rate of 47.7%, and median PFS of 5.7 months). Median duration of treatment was 12 weeks (4 cycles) for G and C and 16 weeks (5 cycles) for N; the median relative dose intensity was 85% for G and 93% for C and N. Twenty-eight (46%) patients continued on single-agent N (median: 4 cycles). Skin reactions (n=49; 80.3%) and hypomagnesemia (n=21; 34.4%) were the most commonly reported adverse events of special interest (AESIs, all grades). AESI ≥ Grade 3 were skin reactions (n=8; 13.1%), thromboembolic events (n=7; 11.5%), hypomagnesemia (n=6; 9.8%), and hypersensitivity/ IRR (n=3; 4.9%). There were 27 deaths (20 due to PD and 7 due to AEs [5 had no causal relationship to study drug]) at the time of data cut-off.

      Table. Efficacy Results
      ORR*† (CR+PR), n (%) [95% CI] 26/54 (48.1)† [34.34–62.16]
      CR 0
      PR, n (%) 26/54 (48.1)†
      SD 18 (29.5)
      PD 9 (14.8)
      Not evaluable 1 (1.6)
      Not assessable 7 (11.5)
      DCR CR+PR+SD, n (%) [95% CI] 44 (81.5)† [68.57–90.75]
      Median OS, months (95% CI) 11.7 [7.59–NA]
      1-year survival rate, % (95% CI) 47.6% [30.20–63.08]
      Median PFS, months (95% CI) 5.6 [3.68–6.87]
      Median CTS, (%) 42.1
      *Assessed by investigators
      †Patients who had a post-baseline radiological assessment, n=54

      The efficacy results and the safety profile, with N manufactured under process D, are consistent with what is expected for this combination as first-line therapy of patients with metastatic Sq-NSCLC.

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