Abstract
Safety of anti-EGFR necitumumab (neci) was evaluated in combination with anti-PD1 pembrolizumab (pembro) in pre-treated Stage IV NSCLC patients (pts). Single-arm, multicenter Phase 1b study with expansion cohort to investigate the safety and effectiveness of neci combined with pembro in pts with Stage IV NSCLC. Part A: escalating doses of neci (600 mg and 800 mg IV) were administered on Day 1 and 8 every 3 weeks (Q3W) in combination with pembro (200 mg IV) on Day 1 Q3W. Part B: expansion cohort with neci at dose identified in Part A administered with pembro. Major eligibility criteria included progression after 1 platinum-based chemotherapy and ECOG PS 0-1. Tumor tissue was collected for analysis of biomarkers. Treatment continued until disease progression or unacceptable toxicity. We present data from an interim safety analysis conducted after the first 15 pts who received the recommended neci 800mg dose completed ≥2 cycles of treatment or discontinued early. All pts in Part A were included. Part A completed without dose-limiting toxicity. As of 11 Feb 2016, 18 pts (neci 600 mg n = 3, 800 mg n = 15) were eligible for inclusion. Patients were female 44.4%, had median age 66.5 years [range 48-76], and adenocarcinoma histology 77.8%. All pts experienced ≥1 treatment-emergent adverse event (AE) with ≥1 related to study treatment. Four serious AEs occurred in 3 (16.7%) pts (all respiratory and mediastinal); none were treatment-related. No discontinuations or deaths were attributable to AEs. AEs occurring with >15% frequency are listed (table). Four (22.2%) pts experienced 8 grade >2 AEs: acute respiratory failure, hypokalaemia, hypophosphataemia, infusion-related reaction, pulmonary embolism, raised gamma-glutamyl transferase (1 pt each), and dyspnoea (2 pts).Tabled 1Treatment-emergent AEs of frequency >15%, n (%)MedDRA preferred termInterim safety population (N = 18)Dermatitis acneiform16 (88.9)Dry skin8 (44.4)Asthenia7 (38.9)Appetite decreased4 (22.2)Constipation4 (22.2)Headache4 (22.2)Hypoalbuminaemia4 (22.2)Hypophosphataemia4 (22.2)Pruritus4 (22.2)Anaemia3 (16.7)Diarrhoea3 (16.7)Dyspnoea3 (16.7)Fatigue3 (16.7)Hypokalaemia3 (16.7)Respiratory tract infection3 (16.7)Stomatitis3 (16.7) Open table in a new tab The combination neci and pembro appears tolerable. The safety profile corresponds to individual profiles for both drugs, with no additive toxicities.
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