There was no major news in the cancer space this week, except the failure of Pfizer Inc.’s PFE Bavencio in a gastric cancer study. In a setback to Eisai Co., Ltd. ESALY, National Institute of Health and Care Excellence (“NICE”) did not recommend the approval of its breast cancer drug, Halaven, for use in second-line setting in UK.
Meanwhile, AstraZeneca’s AZN filing for label expansion of Tagrisso in first-line setting for treating lung cancer was accepted by the European Medicines Agency (“EMA”). Apart from this, Bristol-Myers’ BMY blockbuster drug, Opdivo, again proved its worth by achieving superior overall survival (“OS”) in a phase III lung cancer study. Moreover, Celldex Therapeutics, Inc. CLDX also announced initiation of a phase I study on its new oncology candidate, CDX-1140, in solid tumors.
Recap of the Week’s Most Important Stories
Pfizer’s Bavencio Fails in Gastric Cancer Study: Pfizer along with its Germany-based partner Merck KGaA announced the failure of a phase III study evaluating their key pipeline candidate, Bavencio (avelumab), for the treatment of gastric cancer in third-line setting.
The study – JAVELIN Gastric 300 – evaluated Bavencio as a monotherapy in patients with unresectable, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma and whose disease has progressed following two prior therapeutic regimens. However, another study, JAVELIN Gastric 100, continues to evaluate the drug in first-line switch maintenance setting. (Read more: Pfizer/Merck KGaA's Bavencio Fails in Gastric Cancer Study)
Eisai’s Halaven Suffers Setback in UK: Eisai announced that NICE did not recommend approval for Halaven in UK in second-line setting for treating locally advanced or metastatic breast cancer who have received chemotherapy. The approval would have given competitive advantage to the drug. The drug is already approved in the UK in third or later line setting for the same indication.
Bristol-Myers’ Opdivo Superior in Lung Cancer Study: Bristol-Myers’ PD-1 immune checkpoint inhibitor, Opdivo, achieved superior OS compared to docetaxel in a phase III study. The study – CheckMate -078 – evaluated the drug in previously treated advanced or metastatic non-small cell lung cancer. The study, which was conducted mainly in Chinese patients, achieved its primary endpoint of OS earlier than expected. The company’s biologics license application, filed on the basis of the positive results from the study, has been accepted by the China Food and Drug Administration.
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This week the EMA accepted Mylan’s MYL marketing authorization applications for a biosimilar of Roche’s RHHBY breast and gastric cancer drug, Herceptin, and Amgen’s neutropenia drug, Neulasta.
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