The only reason to develop a new PD-1/PD-L1 is as a platform for combination with other agents
JohnWayne Friday, 11/16/18 12:23:25 PM Re: DewDiligence post# 222345 0 Post # of 222360 AZN - agreed that MYSTIC is a negative trial more so due to the statistical design rather than the activity or lack thereof of Imfinzi monotherapy. That said, I highly doubt there will be any meaningful off-label use of Imfinzi in 1L NSCLC across any PD-L1 expression level. The mental leaps a clinician would have to make to justify such a decision are too great in the face of Keytruda's blanket approvals across the market, let alone any logistical leaps with regard to access and reimbursement.
. DewDiligence Member Level Friday, 11/16/18 12:30:17 PM Re: JohnWayne post# 222346 0 Post # of 222360 Agree strongly with your post. My contention is not that Imfinzi monotherapy will garner material off-label use in NSCLC (it won't), but rather that Imfinzi isn't tainted to the degree one might think from reading today’s write-ups on MYSTIC. Thus, Imfinzi could yet see expanded sales from new indications during the next few years.
. rfj1862Member Level Friday, 11/16/18 12:43:00 PM Re: JohnWayne post# 222346 0 Post # of 222360 Quote: That said, I highly doubt there will be any meaningful off-label use of Imfinzi in 1L NSCLC across any PD-L1 expression level. The mental leaps a clinician would have to make to justify such a decision are too great in the face of Keytruda's blanket approvals across the market, let alone any logistical leaps with regard to access and reimbursement.
The only reason to develop a new PD-1/PD-L1 is as a platform for combination with other agents. There's no point in spending the money on pursuing monotherapy indications or really any indication already addressed by Keytruda or Opdivo--including those that are being evaluated in Phase 3 clinical trials.