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G. Golden

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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      88P - Feasibility of outpatient dinutuximab (D) and irinotecan (I) for second-line treatment of relapsed or refractory small cell lung cancer (RR SCLC): Part 1 of an open-label, randomized, phase 2/3 study (ID 589)

      12:30 - 13:00  |  Author(s): G. Golden

      • Abstract
      • Slides

      D, a chimeric monoclonal antibody that binds cell-surface GD2 expressed on SCLC, can cause significant pain. Combined tolerability with I in RR SCLC patients (pts) is unknown.

      Part 1, an intrasubject dose-escalation lead in to the main study, investigated outpatient use of D + I. Eligibility: RR SCLC following first-line platinum-based therapy with a life expectancy of ≥12 weeks, PS 0-1. Pts received intravenous (IV) D and I (fixed dose 350 mg/m[2]) on Day 1 q 21-days. D was dosed 10 mg/m[2], and increased 2 mg/m[2]/cycle, if pain was < Grade 2, no opioid medications were required, and prior dose was otherwise tolerated. Doses could be decreased based on toxicity observed. Pretreatment included IV hydration, antihistamines, and antipyretics. Pts were monitored for 4 hours after D. Pts remain on treatment until intolerance, progression, or death.

      12 pts were treated (8 male) in US and Spain. Mean (range) age was 68 (47–79) years. A median (range) of 3 (2–4) cycles were completed per pt. Median (range) D dose achieved was 14 (10–16) mg/m[2]. 121 adverse events (AEs) were reported in the Table. There were no grade (gr) 5 AEs. Pain AEs, attributable to D, were mainly gr 1 (80%), with most resolving within hours of infusion; one subject experienced gr 3 AEs, and received the same D dose in the subsequent cycle. Overall, pain did not result in D dose reductions, discontinuations or hospitalizations. Most other AEs were GI in nature and likely attributable to I.

      AEGrade, N subjects (%)
      Back pain5 (41.7%)1 (8.3%)1 (8.3%)0
      Pain in extremity3 (25.0%)000
      Abdominal pain1 (8.3%)1 (8.3%)00
      Arthralgia1 (8.3%)01 (8.3%)0
      Headache2 (16.7%)000
      Diarrhea10 (83.3%)2 (16.7%)00
      Nausea5 (41.7%)3 (25.0%)00
      Cough3 (25.0%)1 (8.3%)00
      Vomiting3 (25.0%)1 (8.3%)00
      Anaemia2 (16.7%)01 (8.3%)0
      Constipation3 (25.0%)000
      Decreased appetite3 (25.0%)1 (8.3%)00
      Asthenia2 (16.7%)1 (8.3%)00
      Dehydration2 (16.7%)000
      Fatigue1 (8.3%)1 (8.3%)00
      Hypomagnesaemia1 (8.3%)1 (8.3%)00
      Infusion related reaction1 (8.3%)000

      D up to 16 mg/m[2] + I have been tolerated with no unanticipated AEs. Part 2 of the study has begun and will randomize ∼460 subjects to: I vs. D + I vs. topotecan.

      Clinical trial identification:
      EudraCT 2017-000758-20 ClinTrials NCT03098030

      Legal entity responsible for the study:
      United Therapeutics Corporation

      United Therapeutics Corporation

      M.J. Edelman: Primary investigator for this corporate-sponsored research. O. Juan, A. Navarro: Principal investigator for this corporate-sponsored research. G. Golden, A. Saunders: Employed by United Therapeutics Corporation who is the sponsor of this study.

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