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Patricia Rich



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    OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
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      OA03.03 - Initial Efficacy and Safety Results of Irinotecan Liposome Injection (nal-IRI) in Patients with Small Cell Lung Cancer (Now Available) (ID 1985)

      13:30 - 15:00  |  Author(s): Patricia Rich

      • Abstract
      • Presentation
      • Slides

      Background

      SCLC accounts for ~15% of lung cancers, with 5-year survival <10%. 50-90% of patients with extensive disease respond to initial treatment; many rapidly relapse due to acquired resistance to front-line platinum-based chemotherapy. Limited treatment options are available for second-line patients. nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor), utilizing intraliposomal stabilization technology to enable high drug load and in-vivo stability.

      Method

      RESILIENT (NCT03088813) is a two-part Phase 2/3 study assessing the safety, tolerability, and efficacy of monotherapy nal-IRI in SCLC patients who progressed on/after a front-line platinum regimen: Part 1 includes dose-finding then dose-expansion. Key eligibility criteria included ECOG PS 0-1 and adequate organ function, with prior exposure to immunotherapy allowed. Eligible patients received nal-IRI 70mg/m2 or 85mg/m2 (free-base equivalent) q2w. Primary endpoints were safety and tolerability. Efficacy assessments included objective response rate (ORR), best overall response (BOR), progression-free survival (PFS), and overall survival (OS).

      Result

      30 patients were treated for >12 weeks in Part 1 (male, 43%; median age, 60.4y; platinum-resistant, 40%) with tumor assessments q6w. During dose-finding, 5 patients received nal-IRI 85mg/m2 (deemed not tolerable: dose-limiting toxicity) and 12 patients received nal-IRI 70mg/m2 (deemed tolerable: selected for dose expansion). At data cut-off** (median follow-up, 4.4mo), 25 patients had received nal-IRI 70mg/m2. Diarrhea was the most common gastrointestinal adverse events (AEs) (Gr3, 20%). Hematologic AEs included neutropenia (Gr3, 8%; Gr4, 8%), anemia (Gr3, 8%), febrile neutropenia (Gr3, 4%), thrombocytopenia (Gr3, 4%; Gr4, 4%). Preliminary efficacy identified 11 patients with partial responses (ORR 44%), BOR (PR+SD) of 72%, and 12-week disease control rate (DCR12wks PR+SD) of 48%. PFS and OS are not yet mature.

      Conclusion

      Part 1 demonstrated encouraging anti-tumor activity for nal-IRI 70mg/m2 in patients with SCLC (ORR: 44%, BOR: 72%). nal-IRI 70mg/m2 was generally well tolerated. Future research is warranted to assess nal-IRI in second-line SCLC.

      Table 1. Baseline Demographic, Patient Disposition, Safety & Tolerability, and Clinical Efficacy for Part 1 of the RESILIENT study

      Dose-Finding /
      Dose-Exploration Phase
      Irinotecan
      Liposome
      Injection
      85mg/m2
      (N=5)
      Irinotecan
      Liposome
      Injection
      70mg/m2
      (N=25)
      Baseline Characteristics
      Gender, Male, n (%) 3 (60.0) 10 (40.0)
      Age (Years, median) 62.0 59.0
      Baseline ECOG
      0 1 (20.0) 3 (12.0)
      1 4 (80.0) 22 (88.0)
      Time Since Most Recent Progression (Weeks, median) 3.4 3.2
      Disease Location, n (%)
      Locally Advanced 0 2 (8.0)
      Metastatic 5 (100.0) 23 (92.0)
      Disposition, n (%)
      Patient Completed Study 4 (80.0) 12 (48.0)
      Patient Currently Ongoing* 7 (28.0)
      Deaths 2 (40.0) 6 (24.0)
      Disease Related 1 3
      Adverse Event Not Related to Study Drug 1 1
      Cardiac Arrest 1 -
      Hepatic Failure - 1
      Adverse Event Related to Study Drug 0 2
      Abdominal Sepsis - 2
      Patient Discontinued Treatment 5 (100.0) 18 (72.0)
      Safety & Tolerability, n (%)
      Any Treatment-Emergent Adverse Event (TEAE) 5 (100.0) 25 (100.0)
      Grade 3 or Higher TEAE (≥ 2 patients) 5 (100.0) 15 (60.0)
      Neutropenia 1 (20.0) 4 (16.0)
      Anemia 2 (8.0)
      Thrombocytopenia 2 (8.0)
      Diarrhea 3 (60.0) 5 (20.0)
      Asthenia 2 (8.0)
      General Physical Health Deterioration 2 (8.0)
      Pneumonia 2 (40.0) 1 (4.0)
      Abdominal Sepsis 2 (8.0)
      Hypokalemia 1 (20.0) 2 (8.0)
      Renal Failure 2 (8.0)
      Best Overall Response
      Complete Response (CR)
      Partial Response (PR) 2 (40.0) 11 (44.0)
      Stable Disease 1 (20.0) 7 (28.0)
      Progressive Disease 1 (20.0) 5 (20.0)
      Non-evaluable 1 (20.0) 2 (8.0)
      Objective Response Rate
      CR + PR 2 (40.0) 11 (44.0)
      Non-responder 3 (60.0) 14 (56.0)
      ** Data Cut-off: May 8, 2019.
      * Per RECIST v1.1 or RANO criteria.

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