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- \nAn objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients<\/p>\n<\/li>\n
- \nDiscussions with global regulatory authorities underway<\/p>\n<\/li>\n<\/ul>\n
BASKING RIDGE, N.J. & RAHWAY, N.J.–(BUSINESS WIRE<\/a>)–
\nResults from the IDeate-Lung01<\/a> phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These data were presented today during a late-breaking presentation (OA06.03<\/a>) and included as part of the press program at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25).<\/p>\n\nIfinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.<\/p>\n
\nSCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate.1,2<\/sup> While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.3,4,5,6<\/sup><\/p>\n
\nIn August 2025<\/a>, ifinatamab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.<\/p>\n
\nResponse was assessed in patients who received ifinatamab deruxtecan (12 mg\/kg) in both the dose optimization and single-arm expansion parts of the trial. A confirmed objective response rate (ORR) of 48.2% (95% confidence interval [CI]: 39.6\u201356.9) was observed with ifinatamab deruxtecan in 137 patients with previously treated ES-SCLC as assessed by blinded independent central review (BICR). Three complete responses (CRs), 63 partial responses (PRs) and 54 cases of stable disease (SD) were seen. A median duration of response (DOR) of 5.3 months (95% CI: 4.0\u20136.5) and a disease control rate (DCR) of 87.6% (95% CI: 80.9\u201392.6) were observed. Median progression-free survival (PFS) was 4.9 months (95% CI: 4.2\u20135.5) and median overall survival (OS) was 10.3 months (95% CI: 9.1\u201313.3). Disease progression and time-to-event results support further randomized, controlled assessment.<\/p>\n
\nIn a subset of patients (n=32) receiving ifinatamab deruxtecan as a second-line treatment, a confirmed ORR of 56.3% (95% CI: 37.7\u201373.6) was observed as assessed by BICR. Eighteen PRs and 13 cases of SD were seen in this subset of patients. A median DOR of 7.2 months (95% CI: 3.6\u2013NE) and a DCR of 96.9% (95% CI: 83.8\u201399.9) were observed. Median PFS of 5.6 months (95% CI: 3.9\u20138.1) and median OS of 12.0 months (95% CI: 7.3\u201319.1) were seen.<\/p>\n
\nIn a subset of patients (n=105) receiving ifinatamab deruxtecan in a third-line and beyond setting, a confirmed ORR of 45.7% (95% CI: 36.0\u201355.7) with three CRs, 45 PRs and 41 cases of SD were seen. A DCR of 84.8% (95% CI: 76.4\u201391.0) was observed in these patients.<\/p>\n
\nIn an exploratory analysis, an intracranial ORR of 46.2% (95% CI: 33.7\u201359.0) was observed by CNS RECIST v1.1 in a subset of patients (n=65) with brain metastases at baseline. A full subgroup analysis (2760MO<\/a>) will be presented at 2025 European Society for Medical Oncology (#ESMO25).<\/p>\n
\n\u201cPatients with extensive-stage small cell lung cancer have an extremely poor prognosis despite current standard of care treatment options,\u201d said Myung-Ju Ahn, MD, PhD, Professor, Department of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. \u201cThe impressive response rates observed in IDeate-Lung01 provide further evidence of the potential role that ifinatamab deruxtecan could play in treating this aggressive form of lung cancer.\u201d<\/p>\n
\nThe safety profile observed in IDeate-Lung01 was consistent with that seen for ifinatamab deruxtecan in the phase 1 trial with no new safety signals identified. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 36.5% of patients. The most common (><\/span>10%) grade 3 or higher TRAEs were neutropenia (13.9%), lymphopenia (12.4%), and anemia (10.2%). Seventeen patients (12.4%) had confirmed treatment-related interstitial lung disease (ILD)\/pneumonitis as determined by an independent adjudication committee. The majority of ILD\/pneumonitis events were low grade, with 11 grade 1 or 2 (8.0%), four grade 3 (2.9%), and two grade 5 (1.5%) ILD\/pneumonitis events observed as of the data cutoff of March 3, 2025.<\/p>\n
\n\u201cIn these primary results from IDeate-Lung01, ifinatamab deruxtecan produced clinically meaningful responses in patients with previously treated extensive-stage small cell lung cancer,\u201d said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. \u201cThese data reinforce the potential benefit of this B7-H3 directed antibody drug conjugate in patients who have received one or more lines of platinum-based chemotherapy and will support our ongoing discussions with global regulatory authorities.\u201d<\/p>\n
\n\u201cSmall cell lung cancer is the second most common type of lung cancer globally, with 15 percent of patients impacted by this particularly devastating form of the disease,\u201d said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. \u201cWith limited advances over the last 30 years, there is a high unmet need for new medicines and novel mechanisms of action that could provide additional options to patients with extensive-stage small cell lung cancer.\u201d<\/p>\n
\nA majority of patients (54.7%) in IDeate-Lung01 received a median of two prior lines of treatment, including immunotherapy (81%), topoisomerase I inhibitor (32.1%), lurbinectedin (21.2%), amrubicin (8.8%) and DLL3-targeting T-cell engager (8.0%). As of the data cutoff, the median treatment duration was 4.8 months (range: 0.7\u201322.7) and 14 patients remain on treatment.<\/p>\n
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