Lilly Says Abemaciclib in Phase 1 Study Demonstrated Single-Agent Activity

Lung cancer patients with metastatic squamous cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis. This is in contrast to the progress seen in nonsquamous non-small cell lung cancer (NSCLC).[1] Results from the largest ever Phase III trial in first-line squamous NSCLC announced by Eli Lilly and Company

today provide the first detailed look at a potential new treatment option for these patients. Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR). In the Phase III SQUIRE trial, patients with stage IV metastatic squamous NSCLC showed a statistically significant improvement in overall survival (HR=0.84, p=0.012) with a median survival of 11.5 months when receiving necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared to 9.9 months for those treated with chemotherapy alone. Consistent efficacy results were observed across endpoints and subgroups. Grade 3 or higher adverse events occurring more frequently in patients on the necitumumab arm were hypomagnesemia and rash. The SQUIRE study results (Abstract #8008) were released in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill. Additional safety and efficacy information will be presented at the meeting. "The SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014." Lung cancer is the leading cause of cancer death in the U.S. and most other countries. NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC. Advanced squamous NSCLC represents a high unmet medical need.[2] Improving treatment in this setting has been particularly challenging as patients often have co-morbidities and, unlike nonsquamous NSCLC, research has yet to confirm a molecular oncogenic target that could drive treatment decisions for patients with this disease.[3] "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 twenty years," said Nick Thatcher, Ph.D., FRCP., professor of oncology, University of Manchester, Christie Hospital NHS Trust in Manchester, United Kingdom and the SQUIRE principal investigator. "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."