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 lungekræft 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 melanom (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 afslørede, at virksomheden har indsendt Opdivos ansøgning om behandling af lungekræftindikationer til FDA og EU's farmaceutiske administration. Det ambitiøse Squibb Company vil naturligvis ikke kun være tilfreds med lungekræft og melanom. Faktisk udfører Squibb i øjeblikket mere end 35 undersøgelser af Opdivo alene eller i kombination med andre lægemidler til behandling af forskellige tumortyper. Ifølge analytikere vil Opdivos fremtidige salg nå helt op på 5 milliarder amerikanske dollars.
Kræften immunterapi 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.
Detaljeret engelsk rapport:
Bristol-Myers Squibbs ($ BMY) enestående immun-o nkologiske lægemiddel nivolumab, godkendt sidste måned som Opdivo, opnåede en bragende succes i et sent stadium af lungekræftforsøg, hvilket styrkede salgsforventningerne til den banebrydende behandling.
I et studie med 272 patienter, der satte Opdivo op imod standardkræftdræberen docetaxel, demonstrerede Bristol-Myers-lægemidlet så overlegen overordnet overlevelse sammenlignet med kontrolarmen, at det ramte sit primære endepunkt før tidsplanen, hvilket førte til, at forsøgets dataovervågningskomité anbefalede studiet afsluttes tidligt. Bristol-Myers inviterer nu patienterne i docetaxel-gruppen til at vælge Opdivo gennem et åbent forlængelsesstudie.
Bristol-Myers' behandling er designet til at galvanisere et immunsystemangreb på tumorer ved at blokere en vej kaldet PD-1, som, ukontrolleret, tillader kræftceller at passere uopdaget af kroppens naturlige forsvar. Ligesom Merck's ($ MRK) lignende Keytruda vandt Opdivo sidste år FDA-godkendelse som en behandling for melanom, men Bristol-Myers' lægemiddel står alene i lungekræft, da dets seneste kliniske succes markerer første gang en PD-1-hæmmer har kortlagt en overlevelsesfordel mod sygdommen, sagde virksomheden.
Opdivo’s particular promise in ikke-småcellet lungekræft 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 har indsendt ansøgninger om lungekræft i USA og Europa for Opdivo i lungekræft, og forventer at udvide brugen af lægemidlet senere i år.
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, hoved- og halskræft, glioblastoma, Non-Hodgkin lymphoma and other cancers.
