Biotech Values

[DewDiligence]

AZN—FDA approves Imfinzi/Imjudo/chemo regimen in 1L-NSCLC:

https://www.investegate.co.uk/astrazeneca-plc/azn/imfinzi---imjudo-approved-in-us-for-lung-cancer/202211110700060665G/

Imjudo (tremelimumab) is an anti-CTLA-4 agent. The approved regimen contains a fixed number (5) Imjudo cycles rather than Imjudo dosing until progression or discontinuation as is done with the Imfinzi/chemo portion of the regimen. The fixed-cycle dosing of Imjudo is intended to reduce the cumulative toxicity of the approved regimen. The approval is based on a statsig OS benefit in the triple combination arm of the POSEIDON trial compared to the chemo-only arm (https://www.clinicaltrials.gov/ct2/show/NCT031646).