If there’s one law in oncology R&D, it’s that you don’t cross FDA cancer czar Richard Pazdur. Pazdur is famous for cutting companies to shreds during panel reviews if they come to the agency with questionable data after straying from the path he set...
David MillerWe're all frustrated by the duplication, but what's the solution? Companies are not going to divide disease areas amongst themselves. (Is that even legal under antitrust laws?) So is the FDA going to give approval to all PD-1s when one is successful?
Cancer Manag Res. 2019 Feb 18;11:1623-1629. doi: 10.2147/CMAR.S188551. eCollection 2019.
David MillerThese are great drugs, but there is huge room for improvement in CR rates.
"A total of 4,803 NSCLC patients from nine randomized controlled trials (RCTs) were included for analysis. The incidence of CR in NSCLC patients treated with ICIs was 1.5%"
The Food and Drug Administration is open to the possibility, if a newly expanded research relationship on real world data is any indication.
David MillerHard to overstate the advantages in using parallel data as a substitute for enrolling patients on placebo. Benefits to speed and cost are obvious. Perhaps less so would be removing placebos -- a major barrier to clinical trial enrollment. @matthewherper
Purpose: Anti–PD-(L)1 can provide overall survival (OS) benefits over conventional treatments for patients with many different cancer types. However, the long-term outcome of cancer patients responding to these therapies remains unknown. This study...
David MillerDespite all the celebrations around anti PD-1/L1 drugs, CR rates are predominantly in the single digits. Given new research on huge differences in survival between CR and PR, improving the quality of responses represents a clear unmet medical need.
Adoptive transfer of T regulatory cells (Treg) has been successfully exploited in the context of graft-versus-host disease, transplantation and autoimmune disease. For the majority of applications, clinical administration of Treg requires laborious...
David MillerFully closed-system manufacturing of engineered cellular therapies is a holy grail for a field struggling with high COGS. The headline here suggests they've solved this for unedited Treg, but only the expansion step is in a closed system.