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Pfizer's Kidney Cancer Drug Misses Endpoint in Phase III

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Pfizer Inc. (PFE - Free Report) 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 - Free Report) 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 . 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 - Free Report) 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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