Normally, a successful late-stage drug trial would be good news for drugmakers.
That wasn’t the case in a high-stakes trial involving a combination of lung cancer drugs from AstraZeneca and a Japanese pharma company with the potential to limit or end chemotherapy in treating a common form of lung cancer.
High-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer.
However, on the endpoint of overall survival, the data were not mature, and an early trend was observed in favor of datopotamab deruxtecan versus docetaxel did not meet the threshold for statistical significance.
The data disappointed investors with shares of both drug companies dropping on Monday.
Susan Galbraith, executive vice president of Oncology R&D, AstraZeneca, said: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first Phase III trial results from the datopotamab deruxtecan clinical program provide compelling evidence for the potential role this TROP2-directed antibody-drug conjugate can play in treating patients with lung cancer.”
More than one million people worldwide are diagnosed with advanced nonsmall cell lung cancer each year. Despite advances, most patients eventually experience disease progression and receive chemotherapy. For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC in the absence of other treatment options and despite limited effectiveness and known side effects.
AstraZeneca and Daiichi Sankyo entered into a global collaboration to develop and commercialize Enhertu in March 2019 jointly and datopotamab deruxtecan in July 2020, except in Japan, where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.
AstraZeneca, at last report, has 1,500 working in administrative, logistics and packaging in northern Delaware.
