On January 13, 2015, Huanyu Dakang Medical News pharmaceutical giant Squibb Company ushered in a good start in 2015. The anti-cancer immunotherapy drug nivolumab developed by the company was approved last month under the trade name of Opdivo. In the first month of 2015, Opdivo heard good news again. In a comparative clinical study of lung cancer conducted by Squibb, Opdivo obtained new positive research data. In this clinical study involving 272 lung cancer patients, the researchers compared the efficacy of Opdivo with the current clinical standard therapy docetaxel, and the results proved the obvious advantage of this drug in the overall survival rate of patients. Reached the primary end point expected by previous researchers.
Opdivo is currently the most popular PD-1 drug. PD-1 is a cell cycle checkpoint protein. Its runaway causes tumor cells to escape immune monitoring in the body. According to the decision made by the FDA last month, Opdivo was approved for the treatment of melanoma (related reading: FDA approved Squibb PD-1 inhibitor Nivolumab (Opdivo) three months in advance, the same price as Keytruda) Similar drugs in this field are Keytruda from Merck. The results of Squibb ’s clinical research have made Opdivo the first PD-1 drug to treat lung cancer. More importantly, this result will help Squibb to lead its competitors in PD-1 drug research. Pharmaceutical companies currently active in this area include biomedical giants such as Merck, Roche and AstraZeneca.
Squibb disclosed that the company has submitted Opdivo’s application for the treatment of lung cancer indications to the FDA and the EU pharmaceutical administration. Of course, the ambitious Squibb Company will naturally not only be satisfied with lung cancer and melanoma. In fact, Squibb is currently conducting more than 35 studies of Opdivo alone or in combination with other drugs to treat different tumor types. According to analysts, Opdivo’s future sales will reach as high as 5 billion US dollars.
The cancer immunotherapy research that has emerged in recent years has brought new hope for humans to conquer the disease of cancer. Almost all biomedical giants are planning in this field, hoping to share a cake. However, it is not yet known who will be the biggest winner in this technological revolution.
Detailed English report:
Bristol-Myers Squibb’s ($ BMY) standout immuno-o ncology drug nivolumab, approved last mo nth as Opdivo, scored a resounding success in a late-stage lung cancer trial, bolstering sales expectations for the pio neering treatment.
In a 272-patient study pitting Opdivo against the standard cancer-killer docetaxel, Bristol-Myers drug demo nstrated such superior overall survival compared with the co ntrol arm that it hit its primary endpoint ahead of schedule, leading the trial’s data mo nitoring committee recommend the study be terminated early. Bristol-Myers is now inviting the patients in the docetaxel group to opt into Opdivo through an open-label extension study.
Bristol-Myers’ treatment is designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, which, left unchecked, allows cancer cells to pass undetected by the body’s natural defenses. Like Merck’s ($ MRK) similar Keytruda, Opdivo won FDA approval last year as a treatment for melanoma, but Bristol-Myers’ drug stands alone in lung cancer, as its latest clinical success marks the first time a PD-1 inhibitor has charted a survival advantage against the disease, the company said .
Opdivo’s particular promise in non-small cell lung cancer has led analysts to pencil it in as the most commercially promising among therapies that block PD-1 and the related PD-L1, putting Bristol-Myers ahead of Merck, Roche ($ RHHBY), AstraZeneca ($ AZN) and others. Analysts figure Opdivo will bring in peak sales of around $ 5 billion, and Leerink’s Seamus Fernandez believes the treatment’s potential in lung cancer will take it as high as $ 7.3 billion by 2020. The entire class of therapies is expected to bring in a bout $ 35 billion a year.
Bristol-Myers has submitted lung cancer applications in the US and Europe for Opdivo in lung cancer, expecting to widen the drug’s use later this year.
Like its competitors, Bristol-Myers has mounted an expansive R & D program for its PD-1 candidate, running more than 35 trials in total that test Opdivo alone or as part of a cocktail in renal cell carcinoma, head and neck cancer, glioblastoma, Non-Hodgkin lymphoma and other cancers.