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Pfizer's Drug Combo Betters Survival in Kidney Cancer Study
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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 (MKGAF - Free Report) 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.
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Pfizer's Drug Combo Betters Survival in Kidney Cancer Study
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 (MKGAF - Free Report) 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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