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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Tuesday, November 5, 2024
Datopotamab deruxtecan (Dato-DXd) may be considered a potential new therapeutic option for pretreated patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) who are eligible for subsequent therapy, according to the results of the open-label, global phase III TROPION-Lung01 trial, published in the Journal of Clinical Oncology. This antibody-drug conjugate improved progression-free survival vs docetaxel in this patient population, reported Myung-Ju Ahn, MD, PhD, of Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, and colleagues. In fact, there was a numerical benefit in overall survival, but it did not reach statistical significance.
In the trial, 604 patients had been previously exposed to immunotherapies or targeted therapies. They were randomly and about equally divided into two arms receiving treatments once every 3 weeks: Dato-DXd at 6 mg/kg vs docetaxel at 75 mg/m2.
The median progression-free survival was 4.4 months with Dato-DXd and 3.7 months with docetaxel (P = .004). The most clinically meaningful progression-free survival benefit was seen in the prespecified nonsquamous histology subgroup; median progression-free survival was 5.5 vs 3.6 months (hazard ratio [HR] = 0.63), respectively. The median overall survival in this subgroup was 14.6 vs 12.3 months (HR = 0.84), respectively.
Median overall survival in the entire trial cohort was 12.9 months with Dato-DXd vs 11.8 months with docetaxel. As mentioned, the numerical improvement, however, did not reach statistical significance.
That the clinical activity of Dato-DXd monotherapy varied distinctly in patients with NSCLC in different histologic subgroups was a key finding, the authors stated. In the squamous histology subgroup, median progression-free survival was 2.8 months with Dato-DXd vs 3.9 months with docetaxel (HR = 1.41), and median overall survival was 7.6 vs 9.4 months, respectively (HR = 1.32).
The overall safety profile of Dato-DXd was as expected, with no new safety signals seen. Generally, it was reported to be favorable compared with docetaxel.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
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