Key Highlights
- Phase 2 trial of ifinatamab deruxtecan (I-DXd) in extensive-stage SCLC achieved an objective response rate of 48.2%, with even higher responses (56.3%) in second-line settings.
- The candidate, a B7-H3 directed antibody-drug conjugate (ADC), has already received Breakthrough Therapy Designation (BTD) from the FDA in August 2025.
- Merck and Daiichi Sankyo are preparing for global regulatory discussions, positioning I-DXd as a potential first-in-class therapy to address a major oncology unmet need.
Promising Phase 2 Data Signals Breakthrough Potential
Results from the IDeate-Lung01 trial demonstrated compelling clinical activity in patients with previously treated ES-SCLC. Among 137 patients, I-DXd showed a confirmed ORR of 48.2%, with durable responses and a disease control rate of nearly 88%. Importantly, median overall survival reached 10.3 months, underscoring the potential to extend patient outcomes in an aggressive cancer type with historically poor prognosis.
Enhanced Outcomes in Second-Line Treatment
In the subset of patients receiving I-DXd as a second-line therapy, response rates rose to 56.3%, with a disease control rate approaching 97% and a median overall survival of 12 months. These outcomes signal a significant advance over existing standards of care, especially for patients with limited treatment options following platinum-based chemotherapy.
Strategic Implications for the ADC Pipeline
Ifinatamab deruxtecan is part of Daiichi Sankyo’s rapidly expanding ADC portfolio, leveraging its proprietary DXd technology, while Merck brings deep oncology expertise and global commercialization scale. Together, the collaboration reflects an industry-wide shift toward ADCs as one of the most promising oncology modalities, capable of delivering targeted efficacy across multiple cancer types.
Regulatory Momentum and Industry Impact
With FDA Breakthrough Therapy Designation secured and strong Phase 2 outcomes in hand, Merck and Daiichi Sankyo are accelerating discussions with global health authorities. If approved, I-DXd could become the first B7-H3 directed ADC in oncology, setting a new precedent for biomarker-driven innovation in lung cancer and beyond, while signaling broader momentum for next-generation antibody-drug conjugates in biopharma.
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