AstraZeneca Shares Under Pressure On Some Adverse Events In Late-Stage Lung Cancer Drug Trial

AstraZeneca Plc AZN reported high-level results from the TROPION-Lung01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.

Dato-DXd demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy.

For the dual primary endpoint of overall survival (OS), the data were not mature, and an early trend was observed in favor of datopotamab deruxtecan versus docetaxel that did not meet the prespecified threshold for statistical significance at this interim analysis. 

All-grade interstitial lung disease was generally consistent with prior clinical trials, with the majority being low-grade. Some Grade 5 events were observed (Death related to AE). Probably investors are reacting to this.

Citing BI pharma analyst, Bloomberg noted that though progression-free survival benefit was reported as statistically significant, the lack of numerical detail — a minimum 2-3 month benefit was targeted — will lead to questions regarding clinical significance.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo DSKNY.

In June, the company shared updated results from the TROPION-Lung02 Phase Ib trial, showing additional enrolment and follow-up from the initial presentation that Dato-DXd plus Merck & Co Inc's Keytruda (pembrolizumab) with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic NSCLC without actionable genomic alterations.

The doublet therapy demonstrated objective response rates of 57% and 50%, respectively, with a disease control rate of 91% across cohorts.

Price Action: AZN shares are down 6.09% at $67.21 during the premarket session on the last check Monday.