Phase 3 IDeate-Lung02 Trial of Ifinatamab Deruxtecan for Relapsed SCLC Begins

The first patient has been dosed in the phase 3 IDeate-Lung02 trial, which is evaluating the efficacy and safety of investigational ifinatamab deruxtecan in patients with relapsed small cell lung cancer (SCLC), according to an announcement from Daiichi Sankyo and Merck.

IDeate-Lung02 is a global, multicenter, randomized, open-label trial evaluating the efficacy and safety of ifinatamab deruxtecan versus physician’s choice of chemotherapy with amrubicin, lurbinectedin, or topotecan in patients with relapsed SCLC following disease progression with only one prior line of platinum-based chemotherapy.

The initiation of the phase 3 IDeate-Lung02 trial is based on updated results from a subgroup analysis of the phase 1/2 IDeate-PanTumor01 trial evaluating ifinatamab deruxtecan.

Company officials weighed in on the implications of the IDeate-Lung02 trial and what it could mean for patients with SCLC, which accounts for around 15% of lung cancer cases and has a five-year survival rate of 3%.

“The initiation of the IDeate-Lung02 trial for ifinatamab deruxtecan marks the second pivotal study since the start of our collaboration with Daiichi Sankyo and follows the recent initiation of the REJOICE-Ovarian01 phase 2/3 study for raludotatug deruxtecan,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, in a statement. “This is a significant milestone as we work together to evaluate an innovative medicine that may have the potential to make a meaningful difference in the lives of people facing [SCLC], a difficult-to-treat cancer.”

Ifinatamab deruxtecan is a “specifically engineered potential first-in-class B7-H3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Merck,” company officials said in the announcement. The B7-H3 protein targeted by the ADC has moderate-to-high expression in around 65% of all SCLC tumors and is associated with “disease progression and poor prognosis,” according to the announcement.

Eligible patients will be randomized to receive ifinatamab deruxtecan 12 mg/kg or physician’s choice of chemotherapy. IDeate-Lung02 is expected to enroll approximately 460 patients across Asia, Europe, Oceania, North America, and South America.

The dual primary end points of the IDeate-Lung02 trial are objective response rate (ORR) as assessed by blinded independent central review (BICR) and overall survival. Secondary end points include ORR as assessed by investigator and progression-free survival, duration of response, disease control rate, and time to response, all assessed by both BICR and investigator.

Ifinatamab deruxtecan was granted orphan drug designation by the US Food and Drug Administration in April 2023 and by the European Commission in February 2024 for the treatment of SCLC.

Source: Merck