Release date: 2017-07-07
A month ago, Merck found in two combined studies that the flagship drug Keytruda would lead to a higher risk of death in patients. Subsequently, the US FDA tracked this and stopped the clinical treatment of the drug for multiple multiple myeloma.
A few weeks ago, Merck plans to continue two clinical studies on the drug: KEYNOTE 183 and KEYNOTE 185. At the time, the company had suspended the recruitment of new patients. These multiple myeloma studies are Merck's portfolio of heavy treatments, including Pomalyst and Revlimid, two new biopharmaceutical drugs.
However, the FDA advised subjects to immediately abandon two Phase III studies involving Keytruda and ordered Merck to immediately stop the patient trial in KEYNOTE-023 Queue 1. In this trial, the subjects were treated with anti-multiple myeloma, and the patients will receive a combination of Keytruda, lenalidomide and dexamethasone. Subjects received immunomodulatory (IMiD) treatment before the trial. (To Nadano, lycopene or thalidomide).
The FDA's latest decision will make Merck a headache, which will continue to widen the distance between Merck and its rival Bristol-Myers Squibb PD-1 drug Opdivo. Merck has never been explained or justified by the fact that the combined study will lead to a high risk of death in patients.
Merck shares fell about 1% in after-hours trading.
Roker Perlmutter, president of Merck Research Laboratories, said: "The Merck company attaches great importance to the safety of the subjects. We are very grateful to the researchers and patients involved in these experiments for their efforts and efforts in this important study. Merck's KEYTRUDA development The program covers more than 30 different types of cancer, and the highest priority for developing the drug is to help more cancer patients."
Source: Sina Pharmaceutical News
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