Daiichi Sankyo (DSKYF,4568.T) and Merck & Co Inc. (MRK) announced that Results from the IDeate-Lung01 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).
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 Daiichi Sankyo and Merck.
SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate.
In August 2025, 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.
According to the companies, response was assessed in patients who received ifinatamab deruxtecan (12 mg/kg) during both the dose optimization and single-arm expansion phases of the trial. A confirmed objective response rate (ORR) of 48.2% was observed in 137 patients with previously treated extensive-stage small cell lung cancer (ES-SCLC), as evaluated by blinded independent central review (BICR).
The treatment yielded three complete responses (CRs), 63 partial responses (PRs), and 54 cases of stable disease (SD). The median duration of response (DOR) was 5.3 months, with a disease control rate of 87.6%. Median progression-free survival (PFS) was 4.9 months, and median overall survival (OS) reached 10.3 months. These disease progression and time-to-event outcomes support further randomized, controlled evaluation of the therapy.
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