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Pfizer Lung Cancer Drug’s Overall Survival Data Unfavorable


Pfizer, Inc. PFE announced final overall survival data from a phase III study (PROFILE 1014), evaluating its cancer drug Xalkori for first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).

Xalkori is currently approved for the treatment of ALK+ or ROS1-positive locally advanced or metastatic NSCLC. The product generated sales of $296 million in the first half of 2017, up 8% year over year.

In the PROFILE 1014 study, a statistically significant improvement in overall survival (OS) rates was not observed in patients treated with Xalkori. After a median follow-up of 46 months, the median OS for patients treated with Xalkori was 45.8 months while it was 47.5 months for patients randomized to chemotherapy. Please note that OS was a secondary endpoint of PROFILE 1014 while progression-free survival (PFS) was the primary endpoint. Per data published in the past, a statistically significant improvement in PFS was noticed in the Xalkori arm compared with the chemotherapy arm.

These data were presented at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

Pfizer’s shares have underperformed the industry this year so far. The stock has returned 5.7% during this period, comparing unfavorably with an increase of 14.8% for the industry.

Pfizer’s boasts a strong oncology portfolio/pipeline. The New York-based pharma giant is aggressively working on expanding the labels of its marketed cancer drugs like Ibrance and Xalkori.

Meanwhile, Pfizer’s newly approved immunotherapy, Bavencio, is expected to contribute significantly to the top line.

Bavencio/avelumab received FDA approval for metastatic Merkel cell carcinoma (MCC) in March 2017 and for advanced bladder cancer in May. Bavencio is under review in the EU for MCC with a decision expected in the third quarter of 2017. Pfizer along with partner Merck KGaA is focusing on continuously growing and expanding Bavencio into new indications and markets globally.

Pfizer’s two other oncology candidates have also been approved by the FDA recently. These include Besponsa for relapsed/refractory acute lymphoblastic leukemia in August and Mylotarg for new or relapsed CD33-positive acute myeloid leukemia in September. Other cancer candidates in Pfizer’s pipeline include talazoparib (advanced breast cancer) and dacomitinib (advanced NSCLC with EGFR activating mutations).

Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stocks to Consider

Better-ranked biotech stocks include Alexion Pharmaceuticals, Inc. ALXN, Ligand Pharmaceuticals Incorporated LGND and Regeneron Pharmaceuticals, Inc. REGN, all with a Zacks Rank #1 (Strong Buy). You can seethe complete list of today’s Zacks #1 Rank stocks here.

Shares of Alexion are up 16.9% year to date. Its earnings estimates for 2017 and 2018 have risen 5.5% and 6%, respectively over the past 60 days.

Shares of Ligand have risen 34.2% so far this year.

Regeneron’s shares up 21.2% this year so far. Earnings estimates have risen 16.8% for 2017 while that for 2018 have gone up by 8.1% over the past 60 days.

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