Shares in AstraZeneca PLC (LSE:AZN) were the biggest drag on the FTSE 100 on Tuesday, falling over 4.5% on the back of some disappointing results from a trial of a lung cancer drug.
Late-stage trial results of the TROPION-Lung01 showed that the overall survival rate from the new drug “did not reach statistical significance,” the company said.
The trial was to test the datopotamab deruxtecan (Dato-DXd) antibody-drug conjugate compared to docetaxel, the current standard of care chemotherapy, in adult patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who had been treated with at least one other therapy.
Dato-DXd is being jointly developed by AstraZeneca and Japan's Daiichi Sankyo.
The mixed results "could make it difficult to get approval by the FDA in the US in the coming weeks", said analyst Kathleen Brooks at XTB.
Analysts at UBS said Dato-DXd is a "key pipeline asset" and the possibility of US Food & Drug Administration approval in second-line NSCLC "is a key catalyst" for the fourth quarter.
A debate has been going on among investors ahead of the December date have been whether or not the FDA will require an advisory committee and the requirement for overall survival data from the TROPION study.
Following the disappointing data, UBS cut its probability of success for Dato-DXd in second-line NSCLC to 40% from 80%.
"We lower 2026-2030 group revenue by an average 0.5% and cut company core EPS by an average 1.4%."
** Update: Adds broker comment **