Pfizer’s dacomitinib is being reviewed as a first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients with EGFR-activating mutations.

Of patients with lung cancer, 85% have non-small cell lung cancer (NSCLC), a conditions that is recognized as the leading cause of death globally. Approximately 10-35% of NSCLC tumors have epidermal growth factor receptor (EGFR) mutations that lead to growth of the cancerous cells. The survival rate for this type of lung cancer remains low and there remains significant need for effective treatments.

Pfizer is hoping its candidate dacomitinib will help meet that need. The company has submitted regulatory applications in both the US and Europe for dacomitinib as a first-line treatment of locally advanced or metastatic NSCLC in patients with EGFR-activating mutations.

FDA has accepted Pfizer’s application and granted priority review to the drug. A determination is expected in September 2018. Notably, the company has a second candidate (lorlatinib) accepted for review by FDA for the second-line treatment of patients with NSCLC. FDA’s decision on this application is expected in August 2018.

If approved, dacomitinib, which is a selective and irreversible inhibitor of EGFR, will compete against Merck’s Keytruda, an antibody-drug conjugate that acts as an anti-PD-1 therapy and other drugs such as Bristol-Myers Squibb’s Opdivo. 

Pfizer based its regulatory submissions for dacomitinib on the results of its phase 3 ARCHER 1050 clinical trial, which evaluated the performance of dacomitinib against AstraZeneca’s Iressa (gefitinib) in patients with NSCLC. The median progression-free survival for dacomitinib was 14.7 months compared to 9.2 for Iressa. However, 10% of patients treated with dacomitinib dropped out of the study due to adverse events, compared to only 7% with Iressa. Pfizer will give a final report of the overall survival data for the ARCHER 1050 study later in 2018.