InvestorsHub Logo
Post# of 249883
Next 10
Followers 788
Posts 118598
Boards Moderated 15
Alias Born 09/05/2002

Re: DewDiligence post# 240275

Friday, 03/04/2022 8:22:46 PM

Friday, March 04, 2022 8:22:46 PM

Post# of 249883
FDA approves Opdivo/chemo in neoadjuvant* NSCLC, irrespective of PD-L1 status:

This is a large potential market and Opdivo is the only FDA-approved immunotherapy in the NSCLC neoadjuvant setting (i.e. before surgical resection).

The approval is based on the CHECKMATE-816 study, where Opdivo/chemo bested chemo alone with the HR for EFS=0.63. Additionally, 24% of patients in the Opdivo/chemo arm had a pathological complete response (no detectable cancer) vs 2% in the chemo-only arm.

OS, which was not a primary endpoint in this trial, had an impressive HR=0.57; however, so little alpha was allocated to OS in the statistical analysis plan that the HR=0.57 result was not deemed statsig.

*Stage Ib, II, or IIIa.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.