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Pfizer/Merck KGaA's Bavencio Fails in Gastric Cancer Study
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Pfizer, Inc. (PFE - Free Report) and its Germany-based partner Merck KGaA (MKGAF - Free Report) announced that a phase III study evaluating their key pipeline candidate, avelumab, for the treatment of gastric cancer in the third-line setting, failed to meet the primary endpoint.
The JAVELIN Gastric 300 trial study evaluated avelumab monotherapy for the treatment of unresectable, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients whose disease progressed following two prior therapeutic regimens, regardless of PD-L1 expression. The study failed to demonstrate superior overall survival – the primary endpoint – of avelumab treatment over chemotherapy.
Though this study evaluating avelumab use in a hard-to-treat patient population failed, the other gastric cancer study — JAVELIN Gastric 100 — continues. It is evaluating avelumab in the first-line switch maintenance setting.
Shares of Pfizer have risen 10.4% this year compared with a 15.3% increase for the Large-Cap Pharma industry.
Avelumub, a human anti-PD-L1 antibody, received FDA approval for metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer, in March and for advanced bladder cancer in May, to be marketed by the trade name of Bavencio. Bavencio was also approved in EU and Japan in September for MCC.
Meanwhile, avelumab is being evaluated for different types of cancers both as monotherapy and in combination with other portfolio assets. Pfizer has also initiated avelumab double/triple combination studies for chemotherapy and targeted therapies and has eleven avelumab combination therapies with immuno-oncology agents under development.
Currently, avelumab is being developed for more than 15 types of tumors including gastric/gastroesophageal junction, head and neck, Hodgkin's lymphoma, non-small cell lung, ovarian, renal cell carcinoma and others. These studies are part of the JAVELIN development program. Bavencio is considered to be a key long-term growth driver for Pfizer.
Some better-ranked large-cap pharma stocks include Johnson & Johnson (JNJ - Free Report) and H. Lundbeck A/S , both carrying a Zacks Rank #2 (Buy).
Shares of J&J have risen 21.5% this year so far while 2018 earnings estimates have gone up 1.8% in the past 60 days.
Shares of Lundbeck have risen 26.1% so far this year while 2018 earnings estimates have gone up 3.2% in the past 30 days.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Image: Bigstock
Pfizer/Merck KGaA's Bavencio Fails in Gastric Cancer Study
Pfizer, Inc. (PFE - Free Report) and its Germany-based partner Merck KGaA (MKGAF - Free Report) announced that a phase III study evaluating their key pipeline candidate, avelumab, for the treatment of gastric cancer in the third-line setting, failed to meet the primary endpoint.
The JAVELIN Gastric 300 trial study evaluated avelumab monotherapy for the treatment of unresectable, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients whose disease progressed following two prior therapeutic regimens, regardless of PD-L1 expression. The study failed to demonstrate superior overall survival – the primary endpoint – of avelumab treatment over chemotherapy.
Though this study evaluating avelumab use in a hard-to-treat patient population failed, the other gastric cancer study — JAVELIN Gastric 100 — continues. It is evaluating avelumab in the first-line switch maintenance setting.
Shares of Pfizer have risen 10.4% this year compared with a 15.3% increase for the Large-Cap Pharma industry.
Avelumub, a human anti-PD-L1 antibody, received FDA approval for metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer, in March and for advanced bladder cancer in May, to be marketed by the trade name of Bavencio. Bavencio was also approved in EU and Japan in September for MCC.
Meanwhile, avelumab is being evaluated for different types of cancers both as monotherapy and in combination with other portfolio assets. Pfizer has also initiated avelumab double/triple combination studies for chemotherapy and targeted therapies and has eleven avelumab combination therapies with immuno-oncology agents under development.
Currently, avelumab is being developed for more than 15 types of tumors including gastric/gastroesophageal junction, head and neck, Hodgkin's lymphoma, non-small cell lung, ovarian, renal cell carcinoma and others. These studies are part of the JAVELIN development program. Bavencio is considered to be a key long-term growth driver for Pfizer.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Some better-ranked large-cap pharma stocks include Johnson & Johnson (JNJ - Free Report) and H. Lundbeck A/S , both carrying a Zacks Rank #2 (Buy).
Shares of J&J have risen 21.5% this year so far while 2018 earnings estimates have gone up 1.8% in the past 60 days.
Shares of Lundbeck have risen 26.1% so far this year while 2018 earnings estimates have gone up 3.2% in the past 30 days.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Click here to see them >>