Pfizer, Inc. (PFE - Free Report) announced that a combination of its cancer drugs, Bavencio and Inlyta, significantly improved progression-free-survival (“PFS”) in a pivotal late-stage study. The phase III JAVELIN Renal 101 study evaluated the Bavencio/Inlyta combination against Pfizer’s older kidney cancer drug Sutent for first-line treatment of advanced renal cell carcinoma, the most common form of kidney cancer.
Top-line results from the study showed that treatment with the Bavencio/Inlyta combination led to statistically significant improvement in progression-free survival (PFS) in patients whose tumors had PD-L1 expression greater than 1% as well as in the entire study population regardless of PD-L1 tumor expression. An independent Data Monitoring Committee confirmed the results as part of a planned interim analysis.
The primary endpoint of the study was to show the superiority of the Bavencio/Inlyta over Sutent monotherapy in prolonging PFS or overall survival (OS) in patients with PD-L1+ tumors.
Pfizer mentioned that the study will continue as planned to analyze the other primary endpoint of OS. Based on the interim results for PFS, Pfizer and Merck KGaA will file regulatory applications in the United States. Pfizer is developing Bavencio with its Germany-based partner Merck KGaA.
The study combines an anti-PD-L1 antibody, Bavencio with a tyrosine kinase inhibitor (TKI), Inlyta, which, if approved, will represent a new cancer treatment approach for advanced RCC. Detailed data from the study will be presented at a future medical conference.
Pfizer’s stock has risen 16.8% this year so far, outperforming the industry’s rally of 4.7%.
Bavencio is already approved in metastatic Merkel cell carcinoma, (mMCC), a rare and aggressive skin cancer in the United States, Europe and Japan. It has also received accelerated approval for second-line treatment of locally advanced or metastatic urothelial carcinoma (advanced bladder cancer) in the United States. Inlyta is approved as a monotherapy for the second-line treatment of advanced RCC.
Bavencio is being considered a key long-term growth driver for Pfizer. In January, Pfizer had mentioned that within its immuno-oncology portfolio, focus remains mainly on drug combinations of Bavencio with a variety of Pfizer-targeted agents. The positive data from the latest study supports this belief.
Currently, avelumab is being developed for more than 15 types of tumors including breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, Merkel cell carcinoma, non-small cell lung cancer, ovarian and urothelial carcinoma. These studies are part of the JAVELIN development program.
Other PD-L1 inhibitors on the market are Merck’s (MRK - Free Report) Keytruda, Bristol Myers’ Opdivo and AstraZeneca’s (AZN - Free Report) Imfinzi.
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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