The drug: MPDL3280A/RG7446
The disease: Cancer
The developer: Roche
Peak sales potential: As a leader among the top three immunotherapy developers, Roche is widely seen as a top contender for a drug capable of earning $2.5 billion to more than $3 billion a year. The bulls include Leerink Swann.
The scoop: While Merck's ($MRK) MK-3475 and Bristol-Myers Squibb's ($BMY) nivolumab operate on PD-1, Roche ($RHHBY) believes it can have the same impact on cancer by hitting the opposite end of the target: PD-L1. PD-1 and PD-L1 are partners--a kind of lock-and-key mechanism--that play an important role in the immune system, camouflaging cancer cells while the immune system fights invaders like viruses and bacteria. By targeting either end of the lock and key, a drug can reveal the cancer in such a way that the immune system fields an army of T cells to fight it off. Combining these immunotherapies with other targeted therapies is seen as a major new step in oncology with the potential for remarkable improvements for many cancer patients.
Roche has an immense amount of cachet in the cancer field. Its acquisition of Genentech put it in charge of one of the most impressive development outfits in the world. And that deep respect is paying off here as Roche fastens on MPDL3280A as another groundbreaking oncology therapy.
Technically, this is a mid-stage program. So why is it in the list of top late-stage prospects?
All the leaders in the field are racing ahead, gathering human data in a lunge for early approvals. The FDA has already indicated that it's eager to accelerate approvals for the most promising drugs, and new therapies for dying patients will be at the front of this queue. Some analysts see the first application coming as early as next year, making this one program that deserves careful attention now, rather than later.
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