First Patient with SCLC Dosed With I-DXd in Phase 3 Study
The phase 3 IDeate-Lung02 study has dosed its first patient with small cell lung cancer with the investigational antibody-drug conjugate infinatamab deruxtecan.
Lung cancer: © Crystal Light - stock.adobe.com
The first patient in the phase 3 IDeate-Lung02 study (NCT06203210) has been dosed with the investigational antibody-drug conjugate (ADC) ifinatamab deruxtecan (IDXd; DS-7300) for the treatment of relapsed small cell lung cancer (SCLC).1
“Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head of oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we look to better understand the role of ifinatamab deruxtecan as a potential new medicine for patients with certain types of small cell lung cancer.”
I-DXd is a potential first-in-class B7-H3-directed ADC. It is composed of a humanized anti-B7-H3 monoclonal antibody attached to topoisomerase I inhibitor payloads. In April 2023, the FDA granted I-DXd an orphan drug designation.
According to data from a subgroup analysis of the IDeate-PanTumor01 study (NCT04145622) presented at the 2023 IASLC World Conference on Lung Cancer, at median follow-up of 11.7 months, there was a 52.4% objective response rate (ORR) in patients with SCLC (95% CI, 29.8%-74.3%) treated with I-DXd. The median progression-free survival (PFS) was 5.6 months (95% CI, 3.9-8.1).2
Further, almost all patients had a reduction in target lesion size in post-baseline scans, with a median time to response (TTR) of 1.2 months (95% CI, 1.2-1.4). Partial responses were observed in 47.6% and complete responses in 4.8%, confirmed by RECIST v1.1 criteria. The median duration of response (DOR) was 5.9 months (95% CI, 2.8-7.5). At the data cutoff of January 31, 2023, the median overall survival (OS) was 12.2 months (95% CI, 6.4-not evaluable).
About the Phase 3 IDeate-Lung02 Study
The phase 3 study has enrolled an estimated 468 patients across 229 locations and is still recruiting.3 Patients will be randomized to receive 12 mg/kg of I-DXd intravenously on day 1 of each 21-day cycle until unacceptable toxicity or progressive disease or investigator’s choice of topotecan, lurbinectedin, or amrubicin.3
The study’s primary end points are ORR and OS, and secondary end points include PFS, DOR, disease control rate, TTR, quality-of-life, incidence of adverse events, and pharmacokinetics.
Patients are eligible for enrollment in the study if they have histologically or cytologically confirmed SCLC, received at least 2 cycles of therapy (including only 1 prior platinum-based therapy), and an ECOG performance status of 1 or lower. Those who previously received an exatecan-derived ADC, have uncontrolled cardiovascular disease, or has severe pulmonary compromise are not eligible for participation.
