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Necitumumab Plus Chemotherapy Shows Overall Survival Benefit in Patients With Squamous NSCLC

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Key Points

  • A large phase III study investigating necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as first-line treatment for advanced squamous non–small cell lung cancer show a statistically significant improvement in overall survival of patients with stage IV disease.
  • Patients receiving necitumumab plus chemotherapy had a median survival of 11.5 months compared to 9.9 months for patients treated with chemotherapy alone.
  • Progression-free survival and disease control rate were also significantly improved.

In the large phase III SQUIRE trial of necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin in the first-line treatment of advanced squamous non–small cell lung cancer (NSCLC), patients with stage IV metastatic disease showed a statistically significant improvement in overall survival over patients treated with the chemotherapy regimen alone. The results will be reported at the 2014 ASCO Annual Meeting (Abstract 8008) and were presented at a Lilly Oncology webcast in advance of the meeting.

Study Methods and Results

The trial enrolled 1,093 patients aged 18 years and older with stage IV squamous NSCLC who had not received prior therapy for metastatic disease. Patients were randomly assigned to receive first-line necitumumab plus gemcitabine/cisplatin or gemcitabine/cisplatin alone. Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). The primary endpoint of the study was overall survival.

The study results show that patients in the necitumumab plus chemotherapy arm had improvement in overall survival (hazard ratio [HR] = 0.84, P = .012) with a median survival of 11.5 months compared to 9.9 months for patients treated in the chemotherapy-only arm. Progression-free survival and disease control rate, defined as patients demonstrating either a complete or partial response or stable disease, were also significantly improved.

Grade 3 or higher adverse events occurring more frequently in patients in the necitumumab arm included rash and hypomagnesemia.

Potential First-Line Therapy Option

“These results provide the first detailed look at data that may offer a new first-line treatment option for patients with squamous NSCLC,” said Richard Gaynor, MD, Senior Vice President of Product Development and Medical Affairs for Lilly Oncology. “We believe necitumumab represents a meaningful advance in the treatment of patients with metastatic squamous lung cancer.” According to Dr. Gaynor, Lilly is anticipating a regulatory submission of necitumumab before the end of the year.

According to the American Cancer Society, lung cancer—both small cell and non–small cell—is the second most common cancer in both men and women, excluding skin cancer. The organization estimates there will be about 224,210 new cases of lung cancer this year and an estimated 159,260 associated deaths.

The study was sponsored by Lilly. For full disclosures of the study authors, view the study abstract at abstract.asco.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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