Abstract
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. 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. 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. The combination of necitumumab and abemaciclib in advanced NSCLC is well tolerated when administered according to recommended dosing schedules.
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