Biotech Values

[DewDiligence]

AZN—Imfinzi/Tremelimumab combo not better than chemo in third-line NSCLC in patients with low (or zero) PD-L1 expression (sub-study ‘B’ of ARCTIC phase-3 trial):

https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-reports-results-from-the-arctic-trial-in-third-line-non-small-cell-lung-cancer-24042018.html

AstraZeneca…today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).

In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. Activity and safety of monotherapy arms of sub-study B were consistent with prior published data.

Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.

Tremelimumab is a CTLA-4 inhibitor (same drug class as BMY’s Yervoy).