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D. Morgensztern



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    OA05 - Treatment Advances in SCLC (ID 373)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: SCLC/Neuroendocrine Tumors
    • Presentations: 1
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      OA05.03 - Single-Agent Rovalpituzumab Tesirine, a Delta-Like Protein 3 (DLL3)-Targeted Antibody-Drug Conjugate (ADC), in Small-Cell Lung Cancer (SCLC) (ID 4648)

      14:40 - 14:50  |  Author(s): D. Morgensztern

      • Abstract
      • Presentation
      • Slides

      Background:
      SCLC is one of the most deadly malignancies. Rovalpituzumab tesirine (SC16LD6.5, Rova-T) is a first-in-class ADC directed against DLL3, a novel target identified in tumor initiating cells and expressed in over 80% of SCLC cases.

      Methods:
      Seventy-four patients with progressive SCLC after at least one previous systemic therapy were enrolled in a first-in-human study (NCT01901653), irrespective of DLL3 expression, including 68 at active doses of 0.2-0.4 mg/kg administered intravenously every 3 or 6 weeks. Available archived tumor tissue (n=48) was assessed retrospectively by immunohistochemistry for DLL3.

      Results:
      Among 60 evaluable subjects, active dose levels resulted in a confirmed objective response rate (ORR) of 18% and a confirmed clinical benefit rate (CBR; stable disease or better) of 68%. Among 26 evaluable subjects with DLL3 expression in at least 50% of tumor cells (DLL3-high), confirmed ORR and CBR were 39% and 89%, respectively. Median duration of response was 5.6 months. One-year survival rates among all and DLL3-high subjects were 18% and 32%, respectively. Among primary sensitive relapse patients, confirmed ORR and CBR among all subjects were 24% (8/33) and 67% (22/33); and among DLL3-high subjects were 53% (8/15) and 100% (15/15), with one-year survival rates of 17% and 33%, respectively. Among primary resistant/refractory relapse patients, confirmed ORR and CBR among all subjects were 12% (3/25) and 72% (18/25); and among DLL3-high subjects were 18% (2/11) and 73% (8/11), with one-year survival rates of 21% and 29%, respectively. The most common grade 3 or higher toxicities included thrombocytopenia (12%), serosal effusions (11%), and skin reactions (8%). ADC pharmacokinetics were linear with a terminal half-life of 10 - 14 days and anti-therapeutic antibodies did not develop

      Conclusion:
      Rovalpituzumab tesirine demonstrates encouraging single-agent anti-tumor activity with a manageable safety profile, including among patients with disease resistant or refractory to primary chemotherapy. Further development of rovalpituzumab tesirine in SCLC is warranted.

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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-030 - nab-Paclitaxel/Carboplatin Induction Therapy in Squamous (SCC) NSCLC: Interim Quality of Life (QoL) Results From ABOUND.sqm (ID 4343)

      14:30 - 14:30  |  Author(s): D. Morgensztern

      • Abstract

      Background:
      Despite a high symptom burden in many patients with advanced NSCLC, limited data exist on QoL with first-line chemotherapy. Here we report results of an interim QoL analysis in patients with SCC NSCLC treated with nab-paclitaxel/carboplatin in the induction part of the ongoing ABOUND.sqm study.

      Methods:
      Chemotherapy-naive patients with advanced SCC NSCLC received 4 cycles of induction therapy with nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15 + carboplatin AUC 6 on day 1 (21-day cycles). Patients without progression after induction received (2:1) maintenance nab-paclitaxel 100 mg/m[2] on days 1 and 8 (21-day cycles) + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. The primary endpoint is progression-free survival (randomization to maintenance). Patient-reported QoL (exploratory endpoint) was assessed on day 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L).

      Results:
      207 patients were treated in the induction phase. Median age was 68 years; 66% of patients were male, and 99% had an ECOG PS 0-1. Out of 200 patients treated for ≥ 2 cycles, 180 (90%) completed baseline + ≥ 1 postbaseline QoL assessments. The mean change from baseline in LCSS symptom burden index and total score ranged from 6.6%-10.3% and 5.5%-9.5%, respectively. Clinically meaningful improvements (≥ 10 mm [visual analog scale]) from baseline were observed in composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis in 46% of patients. For individual EQ-5D-5L dimensions, ≥ 82% of patients maintained/improved from baseline and ≥ 33% reported complete resolution (Table).Figure 1



      Conclusion:
      In this interim analysis, 4 cycles of nab-paclitaxel/carboplatin treatment led to clinically meaningful improvements in LCSS pulmonary symptom items. Complete resolution of problems reported at baseline in EQ-5D-5L dimensions was observed in ≥ 33% of patients at least once during treatment. NCT02027428