Pfizer's Kidney Cancer Drug Misses Endpoint in Phase III

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Pfizer Inc.PFE announced that a late-stage study on its kidney cancer drug Inlyta (axitinib) failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS). Accordingly, an independent Data Monitoring Committee recommended the study be stopped at a planned interim analysis. Detailed data from the study will be presented at a future medical meeting.

The phase III ATLAS study was evaluating Inlyta versus placebo as an adjuvant therapy for patients with high risk of recurrent renal cell carcinoma (RCC), a type of kidney cancer, following surgical removal of one or both kidneys.

Shares of Pfizer have risen 0.2% so far this year, comparing favorably with a 2.3% decrease for the industry .

Inlyta is presently marketed for the second-line treatment of patients with advanced RCC. If the ATLAS study was successful, then Inlyta would be able to cater to an expanded patient population - kidney cancer patients who are in the earlier stage of this disease.

Inlyta generated sales of $339 million in 2017, a decline of 15% from 2016.

Meanwhile, Inlyta is being evaluated in two independent global phase III studies in combination with Merck's MRK PD-L1 inhibitor Keytruda and its own PD-L1 inhibitor Bavencio (avelumab), respectively - each compared with Sutent in first-line advanced RCC. These studies continue to be unmodified.

Bavencio is currently approved in metastatic MCC, a rare and aggressive skin cancer, in the United States, Europe and Japan and for the second-line treatment of locally advanced or metastatic urothelial carcinoma (accelerated approval) in the United States.

Pfizer has developed Bavencio in partnership with the German company, Merck KGaA MKGAF . Meanwhile, avelumab is being developed for different types of cancer. The avelumab PD-L1 program has several studies ongoing, both as monotherapy and in combination with other portfolio assets.

Zacks Rank & Key Pick

Pfizer carries a Zacks Rank #2 (Buy).You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Another top-ranked large-cap pharma stock is GlaxoSmithKline GSK with the same Zacks Rank as Pfizer.

Shares of Glaxo have returned 17.5% this year so far. Estimates for 2018 and 2019 have increased by 3.9% and 4.8%, respectively, over the past 60 days.

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Pfizer Inc. (PFE): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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