Necitumumab Approved for Metastatic Squamous Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved necitumumab (Portrazza) for the treatment of patients with metastatic squamous non-small-cell lung cancer (NSCLC).

It is not approved for the second type of non-small cell lung cancer, non-squamous cell.

Based in Indianapolis, IN, Eli Lilly discovers, develops, manufactures, and sells pharmaceutical products worldwide.

The FDA approval follows an informal recommendation from the Oncologic Drugs Advisory Committee in July 2015.

The open-label, multicenter, multinational, randomized trial investigated the safety and efficacy of necitumumab in more than 1,000 patients with metastatic squamous NSCLC who had not received prior therapy for metastatic disease. A combination of Lilly’s treatment and gemcitabine and cisplatin extended patients’ lives by just 1.6 months compared with the old chemotherapies alone, and Portrazza’s positive effect on progression-free survival amounted to less than a week.

NSCLC makes up about 85 percent of all lung cancers, and the squamous form must be approached differently than non-squamous lest patients be harmed.

“Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient”, said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Metastatic squamous NSCLC is a difficult-to-treat form of lung cancer with few treatment options. Patients were randomized to cisplatin-gemcitabine (Gemzar) chemotherapy with or without necitumumab. Grade ≥3 adverse events (AEs) were apparent in 72% of patients treated with necitumumab versus 62% with chemotherapy alone. The INSPIRE trial, in which the compound was given along with pemetrexed and cisplatin to treat non-squamous NSCLC, was shut down early because of an imbalance in the number of deaths attributed to potential thromboembolic events and deaths of all causes in the study arm compared with the control arm. Adverse events leading to discontinuation of treatment occurred at a rate of 31% in the necitumumab/chemotherapy arm and 25% in the chemotherapy alone arm. Overall response rate (ORR) was also assessed and there was no difference between arms, with an ORR of 31 per cent (95 per cent CI: 27-35) for the Portrazza plus gemcitabine and cisplatin arm and an ORR of 29 per cent (95 per cent CI: 25-33) for the gemcitabine and cisplatin arm (p=0.40).