Pfizer Inc.’s (PFE) shares inched up 1.05% after it announced positive data from a phase III study evaluating oncology drug, Xalkori, in treatment naive ALK-positive advanced non-small cell lung cancer (NSCLC) patients.
The phase III, PROFILE 1014 study compared the use of Xalkori versus standard platinum-based chemotherapy regimens in patients with advanced NSCLC. The study met its primary endpoint with Xalkori significantly prolonging progression-free survival (PFS) as compared to standard platinum-based chemotherapy regimens.
Results from the PROFILE 1014 study are in line with the positive data from a phase III study (PROFILE 1007) announced in Jun 2012. PROFILE 1007 showed a significant improvement in PFS in previously treated patients with advanced ALK-positive NSCLC compared to Eli Lilly and Company’s (LLY) Alimta (pemetrexed) or Sanofi's (SNY) Taxotere (docetaxel).
We remind investors that the U.S. Food and Drug Administration (FDA) had initially granted accelerated approval to Xalkori in Aug 2011. In Nov 2013, the FDA granted regular approval to Xalkori for the treatment of patients with metastatic ALK-positive NSCLC as detected by an FDA-approved test. Xalkori sales were $282 million in 2013, up 129% y/y.
The encouraging data from the phase III, PROFILE 1014 study on Xalkori is a positive for Pfizer. We believe this data will augment Pfizer’s label expansion efforts related to Xalkori. Approval for the treatment-naive NSCLC patient population will significantly boost the product’s commercial potential.
Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD). The stock carries a Zacks Rank #1 (Strong Buy).
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