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Pfizer/Merck KGaA Initiate Avelumab-Inlyta Combo Study

Pfizer Inc. PFE, along with partner Merck KGaA MKGAF, announced that the companies have treated the first patient in a phase III study (JAVELIN Renal 101) on avelumab, anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell carcinoma (RCC) setting.

The multicenter, randomized (1:1), open-label phase III study is evaluating avelumab, in combination with Inlyta, in patients with previously untreated advanced RCC. The study will evaluate potential superiority, as assessed by progression-free survival, of the first-line treatment with the avelumab-Inlyta combination, compared to Sutent monotherapy, in patients with unresectable, locally advanced or metastatic RCC with clear cell component.

We note that Inlyta is currently approved in the U.S. for the treatment of advanced RCC after the failure of one prior systemic therapy and in the EU for the treatment of adult patients with advanced RCC after failure of prior treatment with Sutent or a cytokine.

According to the World Cancer Research Fund International, RCC accounts for 2–3% of all malignancies in the world. The National Cancer Institute stated that the 5-year survival rate for patients with distant metastatic RCC is approximately 12%.

Meanwhile, in a separate press release, Pfizer announced encouraging top-line data from the first phase III study (OPAL Broaden) on Xeljanz (tofacitinib) for the treatment of psoriatic arthritis.

The OPAL Broaden study evaluated the efficacy and safety of Xeljanz (5 mg and 10 mg twice daily) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug and were tumor necrosis factor inhibitor (TNFi)-naïve. Results from the study demonstrated that Xeljanz was superior to placebo at three months, thereby meeting the primary efficacy endpoints. Pfizer expects to present detailed results from the study at a future scientific meeting.

The company is also looking forward to reveal data from the second phase III study (OPAL Beyond) in the first half of 2016.

We note that Xeljanz is currently approved in the U.S. for the treatment of moderate-to-severe rheumatoid arthritis.

Pfizer currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. AMAG and Emergent BioSolutions, Inc. EBS, both sporting a Zacks Rank #1 (Strong Buy).

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