IDeate-Lung02 Phase 3 Trial Begins for Ifinatamab Deruxtecan in Relapsed Small Cell Lung Cancer Patients
Friday, August 02, 2024
Daiichi Sankyo (TSE: 4568) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada), have announced that the first patient has been dosed in the IDeate-Lung02 phase 3 trial. This trial is evaluating the effectiveness and safety of ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer (SCLC), compared to the treatment of the physician’s choice of chemotherapy.
Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) developed by Daiichi Sankyo and jointly developed with Merck & Co., Inc.
Small cell lung cancer is the second most common type of lung cancer, accounting for about 15% of cases. SCLC is aggressive and progresses quickly to the metastatic stage, which has a five-year survival rate of only 3%. Approximately 65% of all SCLC tumors express moderate-to-high levels of the protein B7-H3, which is associated with disease progression and poor prognosis.
“Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, Global Head of Oncology Clinical Development at Daiichi Sankyo. “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.”
Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development at MSD Research Laboratories, added, “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. 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 small cell lung cancer, a difficult-to-treat cancer.”
The initiation of IDeate-Lung02 is based on updated results from a subgroup analysis of the IDeate-PanTumor01 phase 1/2 trial of ifinatamab deruxtecan presented at the 2023 World Conference on Lung Cancer.
IDeate-Lung02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of ifinatamab deruxtecan (I-DXd) versus the physician’s choice of chemotherapy (amrubicin, lurbinectedin, or topotecan) in patients with relapsed SCLC following disease progression with only one prior line of platinum-based chemotherapy. Eligible patients will be randomized to receive ifinatamab deruxtecan (12 mg/kg) or the physician’s choice of chemotherapy.
The dual primary endpoints are objective response rate (ORR) as assessed by blinded independent central review (BICR) and overall survival. Secondary endpoints include ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, and time to response – all assessed by both BICR and the investigator.
IDeate-Lung02 is expected to enroll approximately 460 patients across Asia, Europe, Oceania, North America, and South America. For more information, please visit ClinicalTrials.gov.
More than 2.48 million lung cancer cases were diagnosed globally in 2022. Small cell lung cancer is the second most common type of lung cancer, accounting for about 15% of cases. SCLC is aggressive and progresses rapidly to the metastatic stage, which has a five-year survival rate of only 3%. While conventional first-line therapy for patients with advanced SCLC may help some patients live longer, the current second-line standard of care offers limited clinical benefit, and new treatment approaches are needed.
B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors, including PD-1. B7-H3 is overexpressed in a wide range of cancer types, including small cell lung cancer, and its overexpression correlates with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of any cancer.
Ifinatamab deruxtecan (I-DXd) is an investigational, potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan comprises a humanized anti-B7-H3 IgG1 monoclonal antibody attached to topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Ifinatamab deruxtecan is being evaluated in a global development program, which includes IDeate-Lung02, a phase 3 trial in patients with relapsed SCLC versus investigator’s choice of chemotherapy; IDeate-Lung01, a phase 2 monotherapy trial in patients with previously treated extensive-stage SCLC; and IDeate-PanTumor01, a phase 1/2 first-in-human trial in collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN. Ifinatamab deruxtecan was granted orphan drug designation by the U.S. Food and Drug Administration in April 2023 and by the European Commission in February 2024 for the treatment of SCLC.
Daiichi Sankyo and Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.
Source: daiichisankyo.com
