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Jun Wu



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    MA14 - The Adequate MTarget Is Still the Issue (ID 140)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA14.03 - EGFR M+ Subgroup of Phase 1b Study of Telisotuzumab Vedotin (Teliso-V) Plus Erlotinib in c-Met+ Non-Small Cell Lung Cancer (Now Available) (ID 1622)

      15:45 - 17:15  |  Author(s): Jun Wu

      • Abstract
      • Presentation
      • Slides

      Background

      Telisotuzumab vedotin (ABBV-399; teliso-v) is an anti-c-Met antibody conjugated with monomethyl auristatin E, a tubulin polymerization inhibitor. Preliminary activity was reported for the teliso-v + erlotinib combination in c-Met overexpressing (c-MET+) non-small cell lung cancer (NSCLC) patients, with an activating EGFR mutation and for whom prior EGFR TKI failed. We present mature data from the EGFR M+ subgroup of the teliso-v + erlotinib cohort of a phase 1b study (NCT02099058).

      Method

      Teliso-v was administered at 2.4 mg/kg (dose-escalation phase) or 2.7 mg/kg intravenously once every 3 weeks, and erlotinib at 150 mg orally once a day/prior tolerated dose in adult patients with advanced NSCLC. For efficacy analysis, c-Met+ was defined as central lab IHC H-score ≥150 or local lab MET amplification (MET/CEN7 ≥2); EGFR M+ was defined as del19 or L858R by local lab. Pharmacokinetics were assessed. All patients who received teliso-v + erlotinib were evaluated for safety.

      Result

      As of Dec 2018, 42 NSCLC patients received teliso-v + erlotinib; 37 were c-MET+ (36 evaluable: 35 H-score≥150, 1 MET amplified). Median age was 65 years, 25 patients (69%) had ECOG PS 1, 29 (81%) were EGFR M+ (of these: 48% had T790M, 10% had MET amplification, 3% had polysomy, 97% had prior EGFR TKI, 55% 3rd-generation TKI, 69% TKI as last prior therapy, and 62% platinum doublet). All-grade (≥20%) adverse events (AEs) were dermatitis acneiform (38%), diarrhea (36%), peripheral motor/sensory neuropathy (52%; 7% Grade 3), dyspnea, fatigue, hypoalbuminemia (31% each), decreased appetite, nausea (24% each), asthenia, vomiting (21% each). Grade ≥3 (≥10%) AE: pulmonary embolism (14%). Pharmacokinetics of teliso-v for the combination were similar to single-agent teliso-v. The table presents efficacy data.

      Patients with EGFR mutation
      (n=29)

      Objective response rate*, % (95% CI)
      Complete response, n

      34.5 (17.9, 54.3)
      1

      Median duration of response, months
      (95% CI)

      NR
      (2.8, NE)

      Median PFS, months (95% CI)

      NR
      (2.8, NE)

      Median follow-up, months 4
      6-month PFS rate, % (95% CI)

      51 (30, 69)

      Median treatment duration, month (range)
      Teliso-v
      Erlotinib


      3.5 (0.71–10.4)
      5.3 (0.71–25.4)

      Objective response rate by subgroup of interest, n (%)
      Received prior 3rd generation EGFR TKI
      C-met amplified, copy number gain, or polysomy
      EGFR TKI-containing regimen as last-line therapies


      6/16 (37.5)
      5/7 (71.4)
      8/20 (40.0)

      *RECIST version 1.1.

      EGFR, epidermal growth factor receptor; NE, not estimable; NR, not reached; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; TKI, tyrosine kinase inhibitor;

      Conclusion

      These data suggest acceptable safety and promising activity of teliso-v + erlotinib in patients with c-Met+ NSCLC with an activating EGFR mutation and for whom EGFR TKI has failed.

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-19 - Phase 2 Study of Telisotuzumab Vedotin (Teliso-V) in Previously Treated c-MET+ Non-Small Cell Lung Cancer: Trial in Progress (ID 1986)

      10:15 - 18:15  |  Author(s): Jun Wu

      • Abstract
      • Slides

      Background

      Telisotuzumab vedotin (ABBV-399; teliso-v), an anti–c-Met antibody-drug conjugate, demonstrated favorable antitumor activity in a phase 1/1b trial (NCT02099058) in patients with non-small cell lung cancer (NSCLC) and c-MET protein overexpression (c-MET+). Evidence from this study supported additional analysis of teliso-v in patients with c-MET+ NSCLC. Herein, we describe the first phase 2 study of teliso-v. The aim of this study is to evaluate the potential activity and safety profile of teliso-v as a later line of therapy in a biomarker-selected population(s) of patients with NSCLC.

      Method

      This is a 2-stage (Figure) multicenter, non-randomized, single-arm phase 2 study (NCT03539536) in patients (≥18 years; Eastern Cooperative Oncology Group performance status 0–1) with c-MET+ locally advanced or metastatic histologically confirmed NSCLC. Stage 1 is designed to identify the target c-MET+ NSCLC population(s) best suited for teliso-v therapy in the second- or third-line setting using a novel multifactor Bayesian hierarchical model. In Stage 2, the group(s) that demonstrate promising results during Stage 1 will be expanded in a single-arm cohort to further evaluate teliso-v efficacy in the selected population(s). Teliso-v will be administered intravenously at a dosage of 1.9 mg/kg every 2 weeks until disease progression/intolerable toxicity. The primary endpoint is overall response rate according to Response Evaluation Criteria In Solid Tumors version 1.1. Secondary endpoints include duration of response, disease control rate, duration of disease control, progression-free survival, overall survival, safety, and tolerability. Pharmacokinetic samples will be collected pre-treatment and at specific timepoints during the study. Tumor samples will be collected pre-treatment for biomarker analysis. The trial is active, with the first patient screened on 11/05/2018. As of 3/11/2019, 13 centers in 5 countries have enrolled 3 patients.

      trials in progress figure.png

      Result

      Section not applicable

      Conclusion

      Section not applicable

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