分配至三联治疗的患者中位无进展生存期是5.7个月而分配至只有吉西他滨与顺铂者是5.5个月(HR =0.85；P =.02)。
Necitumumab加入到培美曲塞和顺铂没有改善总生存期(HR=1.01 P =.96)、无进展生存期(HR=0.96)或总有效率(31%对32%)。
FDA Approves Necitumumab for Metastatic Squamous NSCLC
November 24, 2015
The US Food and Drug Administration (FDA) has approved necitumumab (Portrazza), in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small-cell lung cancer (NSCLC).
Necitumumab is not indicated for treatment of non-squamous NSCLC.
Necitumumab is a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands.
Approval was based on a study of 1,093 patients with metastatic squamous NSCLC who had not received prior therapy for metastatic disease.
Patients were randomised to receive necitumumab 800 mg (days 1 and 8) plus gemcitabine 1,250 mg/m2 (days 1 and 8) and cisplatin 75mg/m2 (day 1 of each 3-week cycle; n = 545) or gemcitabine and cisplatin alone (n = 548).
The primary endpoint was overall survival. Progression-free survival (PFS) and overall response rate (ORR) were also assessed.
Median OS was 11.5 months for patients in the necitumumab group compared with 9.9 months for those assigned to gemcitabine and cisplatin alone (hazard ratio [HR] = 0.84; P = .01).
Median PFS was 5.7 months for patients assigned to the triple combination therapy versus 5.5 months for those assigned to gemcitabine and cisplatin alone (HR = 0.85; P = .02).
No difference in ORR between arms was observed with an ORR of 31% for the necitumumab group and 29% for the dual therapy group.
Lack of efficacy of necitumumab in combination with pemetrexed and cisplatin (PC) for the treatment of patients with metastatic non-squamous NSCLC was determined in a randomised, open-label, multicentre trial.
Patients with no prior chemotherapy for metastatic disease were randomised (1:1) to receive necitumumab plus PC or PC alone.
The study was closed prematurely after 633 patients were enrolled due to increased incidence of death due to any cause and of thromboembolic events in the necitumumab arm. Addition of necitumumab to PC did not improve OS (HR = 1.01P = .96), PFS (HR = 0.96), or ORR (31% vs 32%).
The most common adverse reactions (all grades) observed in necitumumab-treated patients at a rate of ≥30% and ≥2% than the gemcitabine and cisplatin alone arm were rash and hypomagnesemia.
Serious and clinically significant adverse events included hypomagnesemia, venous and arterial thromboembolic events, dermatologic toxicities, infusion reactions, and increased toxicity and increased mortality in patients with non-squamous NSCLC.
Death attributed to cardiovascular events or sudden death was reported in 3% of the patients in the necitumumab group.
Health care providers should closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after necitumumab administration. Withhold necitumumab for grade 3 or 4 electrolyte abnormalities.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
SOURCE: US Food and Drug Administration