KEY TAKEAWAYS
- The phase III TROPION-Lung01 trial compared Dato-DXd with DTX in previously treated adv/met NSCLC patients.
- The study’s primary endpoints were PFS and OS. Secondary endpoints included ORR, DOR, and safety.
- The study showed that Dato-DXd improved outcomes compared to DTX in patients with previously treated adv/met NSCLC.
Dato-DXd is an experimental antibody-drug conjugate targeting TROP2. The TROPION-Lung01 phase 3 clinical trial compared Dato-DXd with docetaxel (DTX) in previously treated patients (pts) with advanced or metastatic non-small cell lung cancer (adv/met NSCLC), both with and without actionable genomic alterations (AGAs).
Patients were equally divided between two treatment arms: Dato-DXd at 6 mg/kg and DTX at 75 mg/m2, administered every three weeks. The study aimed to assess two primary endpoints: progression-free survival (PFS) as evaluated by blinded independent central review (BICR), and overall survival (OS). Additional outcomes studied included objective response rate (ORR), duration of response (DOR), and the safety profile.
In the Full Analysis Set (FAS) consisting of 604 pts, 43.1% had undergone at least two prior rounds of systemic therapy. The median age of pts was 64 years, with an age range of 24 to 88 years. PFS was notably better in pts treated with Dato-DXd compared to those receiving DTX, with a hazard ratio (HR) of 0.75 and a 95% confidence interval (CI) of 0.62-0.91 (P=.004). The median PFS was 4.4 months for Dato-DXd versus 3.7 months for DTX. Confirmed ORRs were 26.4% for Dato-DXd and 12.8% for DTX. The median DOR was 7.1 months for Dato-DXd and 5.6 months for DTX. A longer median PFS was observed in a prespecified subgroup with non-squamous histology (NSQ) (5.6 vs 3.7 months). The median length of treatment was 4.2 months for Dato-DXd and 2.8 months for DTX, with treatment durations ranging from 0.7 to 18.3 months and 0.7 to 18.9 months, respectively.
The most frequently encountered treatment-emergent adverse events (TEAEs) with Dato-DXd were stomatitis, affecting 49.2% of pts (mostly grade 1/2), and nausea in 37%. Severe drug-related interstitial lung disease of grade ≥3 was observed in 3.4% of pts on Dato-DXd, as compared to 1.4% with DTX. Dato-DXd also had fewer severe TEAEs and adverse events that led to dose modifications or treatment discontinuation than DTX.
Source: https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/show/session/156
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04656652
Lisberg, A.E. Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): Results of the randomized phase III study TROPION-Lung01.
