Replies to post #217306 on Biotech Values

[DewDiligence]

Avelumab fails OS endpoint for PD-L1≥1% in second-line NSCLC:

https://finance.yahoo.com/news/merck-kgaa-darmstadt-germany-pfizer-133000077.html

Merck KGaA…and Pfizer today announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy.

…the trial did not meet its prespecified endpoint of improving overall survival (OS) in patients with programmed death ligand-1-positive (PD-L1+) (1% or higher) tumors (HR: 0.90 [96% CI: 0.72-1.12], p-value 0.1627, one-sided)…

…improvements in OS versus the control arm were observed in the moderate-to-high PD-L1+ expression (50% or greater, which represented approximately 40% of the study population) and high PD-L1+ expression population (PD-L1+ expression 80% or greater, which represented approximately 30% of the study population) (HR: 0.67 [95% CI: 0.51-0.89], p-value 0.0052, two-sided; and HR 0.59 [95% CI: 0.42-0.83], p-value 0.0022, two-sided, respectively)…

PFE and Merck KG apparently picked an unduly low cut-off (1%) for PD-L1 expression to define the patient pool and primary endpoint; 50% would’ve worked well.

[DewDiligence]

PFE files mixed shelf registration—hmm…

https://www.sec.gov/Archives/edgar/data/78003/000119312518058451/d511637ds3asr.htm