Author of

• 18374

  +

  P3.02b - Poster Session with Presenters Present (ID 494)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18436

    +

    P3.02b-062 - Safety of Necitumumab and Abemaciclib Combination Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 4270)

    14:30 - 14:30  |  Author(s): B. Frimodt-Moller
    • Abstract
    • Slides

    Background:
    Trials of anti-EGFR necitumumab and the CDK4 and CDK6 inhibitor abemaciclib have demonstrated anti-tumor activity of each agent in patients with NSCLC. In a xenograft model of NSCLC, the addition of necitumumab to abemaciclib improved the anti-tumor efficacy compared to either monotherapy.
    
    Methods:
    Single-arm, multicenter Phase 1b study to investigate the combination of necitumumab and abemaciclib in patients with stage IV NSCLC (NCT02411591). The safety interim population includes squamous and non-squamous patients treated with the recommended dose of necitumumab 800mg IV on days 1 and 8, every 21 days in combination with abemaciclib 150mg (dose identified in preceding dose escalation part of study) administered every 12 hours on days 1–21. Major eligibility criteria include: progression after platinum-based chemotherapy regimen and maximum 1 other prior chemotherapy for advanced and/or metastatic disease (prior treatment with EGFR-TKI and ALK inhibitors was mandatory in patients whose tumor has EGFR-activating mutations or ALK translocations, respectively); ECOG PS 0-1; tumor tissue availability for biomarker analysis and measurable disease. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent by the patient, or sponsor/investigator decision.
    
    Results:
    This safety interim includes 16 squamous and non-squamous patients treated at recommended dose (necitumumab 800mg + abemaciclib 150mg) and having completed 2 cycles of study treatment (or otherwise discontinued study treatment). The most common (>15% patients) adverse events (AEs) of any grade are shown in the Table. Grade ≥3 AEs were reported in 6 patients (diarrhea, nausea, vomiting, neutropenia, decreased appetite, hypophosphotaemia, dyspnoea were each reported in 1 patient and fatigue in 2 patients); grade ≥3 AEs were judged to be related to study treatment in 4 patients. No patients have discontinued the study due an AE. Figure 1
    
    
    
    Conclusion:
    The combination of necitumumab and abemaciclib in advanced NSCLC is well tolerated when administered according to recommended dosing schedules.
    
    

    Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.