KEY TAKEAWAYS
- The IDeate-Lung01 phase 2 trial aimed to determine the optimal dose of I-DXd in patients with ES-SCLC.
- The primary endpoint was ORR.
- Researchers concluded that higher I-DXd doses showed better responses and were chosen for further studies.
Extensive-stage small cell lung cancer (ES-SCLC) carries a poor prognosis, with limited treatment options available for patients. B7 homolog 3 (B7-H3 [CD276]), an immune checkpoint protein, is highly expressed in SCLC, making it a potential therapeutic target. Ifinatamab Deruxtecan (I-DXd), a B7-H3-directed antibody-drug conjugate, has shown promising efficacy in a phase 1/2 trial (IDeate-PT01) in patients with ES-SCLC.
C.M. Rudin and the team aimed to present reports on the dose-optimization phase of the Phase 2 IDeate-Lung01 study evaluating I-DXd in patients with ES-SCLC.
The phase 2 trial enrolled patients with ES-SCLC who had received 1-3 prior lines of treatment (including platinum-based chemotherapy). Patients were randomized to receive intravenous I-DXd at either 8 mg/kg or 12 mg/kg every 3 weeks.
The primary endpoint was the objective response rate (ORR) as determined by a blinded independent central review. Key secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), time to response, and the overall safety profile.
As of July 25, 2023, 91 patients had been enrolled, with 88 receiving treatment (46 in the 8 mg/kg group and 42 in the 12 mg/kg group). At the time of interim analysis, the median follow-up duration was 5.3 months for the 8 mg/kg group and 5.8 months for the 12 mg/kg group.
The confirmed ORR was 26.1% in the 8 mg/kg group and 52.4% in the 12 mg/kg group. Data regarding DOR, PFS, and OS were not mature at the time of analysis and were slated to be presented at a later date.The 12 mg/kg dose was associated with a higher frequency of any-grade and Grade ≥3 treatment-emergent adverse events (TEAEs) compared to the 8 mg/kg dose.The most common TEAEs reported were fatigue, gastrointestinal issues, and hematologic events.
The IDeate-Lung01 trial showed that patients with heavily pre-treated ES-SCLC had meaningful responses to both doses of I-DXd. The 12 mg/kg dose provided approximately twice the objective response rate of the 8 mg/kg dose and was chosen as the optimal dose for the study’s extension and the phase 3 IDeate-Lung02 trial.
The trial was sponsored by Daiichi Sankyo.
Source: https://cattendee.abstractsonline.com/meeting/20598/presentation/743
Clinical Trial: https://clinicaltrials.gov/study/NCT06203210
Rudin CM, Ahn MJ, Johnson M, et al. (2024). “Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): interim analysis of Ideate-lung01.” Presented at: World Conference on Lung Cancer (WCLC); September 8, 2024; Singapore.
