Portrazza plus gemcitabine and cisplatin demonstrated a statistically significant improvement in overall survival vs gemcitabine and cisplatin alone1
SQUIRE: Overall survival (main outcome measure)
- The percentage of deaths at the time of analysis was 77% (418 patients) in the Portrazza plus gemcitabine and cisplatin arm and 81% (442 patients) in the gemcitabine and cisplatin arm1
Overall survival in patients with metastatic squamous NSCLC1,2
SQUIRE: Overall survival
Efficacy overview: Progression-free survival and overall response rate
Supportive Outcome Measures
*The percentage of events at the time of analysis was 79% (431 patients) in the Portrazza plus gemcitabine and cisplatin arm and 76% (417 patients) in the gemcitabine and cisplatin arm.1
SQUIRE trial design1,2
The phase III open-label, controlled trial evaluated the efficacy and safety of Portrazza plus gemcitabine and cisplatin vs gemcitabine and cisplatin first-line chemotherapy in patients with metastatic squamous NSCLC. Main outcome measure was OS. Investigator-assessed supportive outcome measures were PFS and ORR. All patients were required to have ECOG PS of 0, 1, or 2. Patients were randomized 1:1 to receive either Portrazza 800 mg IV on D1, D8 plus gemcitabine 1250 mg/m2 IV on D1, D8 and cisplatin 75 mg/m2 on D1, or gemcitabine 1250 mg/m2 IV on D1, D8 and cisplatin 75 mg/m2 on D1, q3w, for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients demonstrating at least stable disease on Portrazza plus gemcitabine and cisplatin were to continue Portrazza as a single agent in the absence of disease progression or unacceptable toxicity after completion of 6 planned courses of chemotherapy or if chemotherapy was discontinued for toxicity. In the Portrazza plus gemcitabine and cisplatin arm toxicity, 51% of patients continued Portrazza after completion or discontinuation of chemotherapy.
OS=overall survival; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival; ORR=overall response rate; NSCLC=non-small cell lung cancer; ECOG=Eastern Cooperative Oncology Group; PS=performance status; D=day; q3w=every 3 weeks.
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References: 1. Portrazza (necitumumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015. 2. Thatcher N, Hirsch FR, Luft AV, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015;16(7):763-774.
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