Eli Lilly and Company has reported positive results from a Phase III trial of Necitumumab, a recombinant human IgG1 monoclonal antibody, for treatment of first-line squamous non-small cell lung cancer (NSCLC).
The results from the Phase III SQUIRE trial provide the first detailed look at a potential new treatment option for patients with NSCLC.
Necitumumab is designed to block the ligand binding site of the human epidermal growth factor receptor 1(EGFR).
In the trial, patients with stage IV metastatic squamous NSCLC showed significant improvement in overall survival with a median survival of 11.5 months when receiving necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared with 9.9 months for those treated with chemotherapy alone.
The company said that consistent efficacy results were observed across endpoints and subgroups.
Grade 3 or higher adverse events observed more frequently in patients on the necitumumab arm were hypomagnesemia and rash.
Lilly Oncology senior vice-president of product development and medical affairs Richard Gaynor said the SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC.
"With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014," Gaynor said.
A total of 1,093 patients with histologically or cytologically confirmed, stage IV squamous NSCLC, who had received no prior therapy for metastatic disease were enrolled in the SQUIRE trial.
The primary endpoint was overall survival and in the trial patients were given first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B.
In the trial, patients underwent radiographic assessment of disease status every six weeks (± 3 days), until radiographic documentation of progressive disease (PD).
University of Manchester professor of oncology and SQUIRE trial principal investigator Nick Thatcher said while there have been several attempts to make progress to address this unmet need, clinical advances in squamous non-small cell lung cancer have been minimal in the last 20 years.
"The addition of necitumumab to the current chemotherapy regimen of gemcitabine and cisplatin opens the door to a potential new approach to treat patients with advanced squamous NSCLC," Thatcher said.
Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.