KEY TAKEAWAYS
- The TROPION-LUNG01 phase III and TROPION-Lung05 phase II trials aimed to test Dato-DXd for advanced NSCLC with gene mutations.
- The primary endpoint was cORR. Secondary endpoints included DOR and DCR by BICR, as well as safety.
- The result demonstrated that Dato-DXd has encouraging antitumor activity with durable responses in heavily pretreated patients.
For advanced lung cancer with specific mutations (NSCLC with AGAs), treatment options dwindle after targeted therapies and chemotherapy fail. Datopotamab deruxtecan (Dato-DXd) is a drug targeting a specific protein with a potent toxin attached, designed to overcome resistance and deliver a targeted attack.
For a study, researchers aimed to test Dato-DXd for advanced nonsmall cell lung cancer(NSCLC) with gene mutations, even for patients who progressed despite targeted therapy and had brain cancer involvement.
The study administered Dato-DXd at 6 mg/kg every 21 days to advanced/metastatic NSCLC patients, ECOG status 0 or 1, and at least one documented actionable genomic alteration (AGA) in EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
The primary endpoint was the confirmed objective response rate (cORR) assessed by a blinded independent central review (BICR). Secondary endpoints included duration of response (DOR), disease control rate (DCR) by BICR, and safety assessments.
About 137 patients, with a median age of 61.0 years and 71.5% having received ≥3 prior lines of therapy for advanced/metastatic non-small cell lung cancer (a/m NSCLC), were included. Among them, 56.9% had EGFR mutations.
As of December 14, 2022, 85.4% discontinued therapy, 63.5% experienced disease progression, and 49.6% died. The median patient duration in the study was 15.2 months, cORR was 35.8%, DCR was 78.8%, and median DOR was 7.0 months; similar responses were observed in patients with EGFR mutations.
The most common grade ≥3 treatment-emergent adverse events(TEAEs) were stomatitis (9.5%), anemia (5.8%), and increased amylase (5.8%).
The result demonstrated that datopotamab deruxtecan has encouraging antitumor activity with durable responses in heavily pretreated patients.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/45
Clinical Trials: https://clinicaltrials.gov/study/NCT04484142
https://clinicaltrials.gov/study/NCT04656652
Kitazono S, Paz-Ares L, Ahn MJ, Lisberg AE, Cho BC, Blumenschein G, Shum E, Pons-Tostivint E, Goto Y, Yoh K, Heist R, Baas P, Planchard D, Pérol M, Felip E, Su WC, Zebger-Gong H, Lan L, Liu C, Sands J. Datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGAs). Presented at TROPION-Lung05; ESMO 2023 Presentation Number 518MO; Lecture Time 10:05 AM – 10:10 AM.
