Phase 3 Trial of Ifinatamab Deruxtecan Launched for Relapsed Small Cell Lung Cancer
Key Insights
Daiichi Sankyo and Merck (search) have initiated the IDeate-Lung02 Phase 3 trial to evaluate ifinatamab deruxtecan (I-DXd) versus chemotherapy in relapsed small cell lung cancer (search) (SCLC).
The trial will assess the efficacy and safety of I-DXd, a potential first-in-class B7-H3 (search) directed antibody-drug conjugate, in patients who have progressed after one prior line of platinum-based chemotherapy.
The primary endpoints of the study are objective response rate (ORR) and overall survival, with secondary endpoints including progression-free survival and duration of response.
Daiichi Sankyo and Merck (search) have commenced the IDeate-Lung02 Phase 3 clinical trial, evaluating the investigational drug ifinatamab deruxtecan (I-DXd) for patients with relapsed small cell lung cancer (search) (SCLC). This global, multicenter study aims to assess the efficacy and safety of I-DXd compared to physician's choice of chemotherapy in patients who have experienced disease progression following one prior line of platinum-based chemotherapy.
Targeting B7-H3 in SCLC
Ifinatamab deruxtecan is an antibody-drug conjugate (ADC) directed against B7-H3 (search), a protein overexpressed in approximately 65% of SCLC tumors and associated with disease progression and poor prognosis. As a potential first-in-class B7-H3 directed ADC, I-DXd represents a novel approach to targeting this aggressive cancer. The drug utilizes Daiichi Sankyo's proprietary DXd ADC technology, linking a humanized anti-B7-H3 antibody to a topoisomerase I inhibitor payload.
Trial Design and Endpoints
The IDeate-Lung02 trial is a randomized, open-label Phase 3 study. Eligible patients will be randomized to receive either ifinatamab deruxtecan (12 mg/kg) or physician’s choice of chemotherapy, which includes amrubicin, lurbinectedin, or topotecan. 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 investigator, progression-free survival, duration of response, disease control rate, and time to response – all assessed by both BICR and investigator.
The trial is expected to enroll approximately 460 patients across Asia, Europe, Oceania, North America, and South America. Additional information is available at ClinicalTrials.gov.
SCLC: An Unmet Need
Small cell lung cancer (search) accounts for about 15% of all lung cancer cases, with over 2.48 million lung cancer cases diagnosed globally in 2022. SCLC is known for its aggressive nature and rapid progression to the metastatic stage, resulting in a five-year survival rate of only 3%. While first-line therapies can extend survival for some patients, the current second-line standard of care offers limited clinical benefit, highlighting the urgent need for new treatment strategies.
Expert Commentary
"Patients living with small cell lung cancer (search) face poor outcomes with currently available treatments," said Mark Rutstein, MD, global head, oncology clinical development, 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, Merck (search) 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... 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 (search), a difficult-to-treat cancer."