Daiichi Sankyo Initiates Phase III IDeate-Lung02 Trial of B7-H3 ADC Ifinatamab Deruxtecan in China for Recurrent Small Cell Lung Cancer
Daiichi - Sankyo
Pharmaceutical Development, Production, Sales, and Consulting Service Provider
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
July 29,Drug Clinical Trial RegistrationAccording to the record and information disclosure platform, Daiichi-Sankyo has launched DS-7300a in China.（ifinatamab deruxtecan，I-DXd）vsInternational Multicenter, Randomized, Open-Label Phase III IDeate Lung02 Study of TPC (Treatment Selected by Physicians) in Relapsed Small Cell Lung Cancer (SCLC).
January this yearDaiichi-Sankyo has already registered and initiated this study on the ClinicalTrials.gov website, planning to recruit 468 patients internationally.The primary endpoints of the study are Objective Response Rate (ORR) and Overall Survival (OS). The part initiated in China is expected to enroll 70 patients.
I-DXd is a B7H3 ADC developed by Daiichi-Sankyo based on its DXd ADC technology platform. It is also one of the projects co-developed with Merck, alongside HER3-DXd (HER3 ADC) and R-DXd (CDH6 ADC).
In September 2023, Daiichi-Sankyo announced the Phase I/II study results of I-DXd (6.4-16.0mg/kg) for the treatment of advanced SCLC patients who had received a median of two prior lines of therapy. The results showed that among 21 advanced SCLC patients treated, the confirmed ORR was 52.4%, including 1 complete response (CR) and 10 partial responses (PR); the median duration of response (mDOR) was 5.9 months, the median progression-free survival (mPFS) was 5.6 months, and the mOS was 12.2 months.
In terms of safety, 36.4% of patients experienced treatment-emergent adverse events (TEAEs) of grade 3 or higher. The most common (incidence >20%) TEAEs were nausea (59.1%), fatigue (50.0%), anemia (27.3%), vomiting (27.3%), and decreased appetite (22.7%). One patient developed a grade 2 AE—treatment-related interstitial lung disease (ILD) or pneumonia.
Lung cancer is the second most common cancer globally, with SCLC accounting for approximately 15% of all cases. The 5-year survival rate for SCLC patients is extremely low, at about 3%. Studies have shown that B7-H3 is highly expressed in approximately 65% of SCLC tumors, which is associated with disease progression and reduced survival rates.
I-DXd is currently the fastest progressing one.B7H3ADC has advanced to the Phase III clinical trial stage.Hansoh Pharma's B7H3The ADC drug HS-20093 followed closely, and a Phase III study was also initiated on the 12th of this month.（NCT06498479）, aiming to evaluate the efficacy and safety of HS-20093 compared with topotecan in patients with small cell lung cancer who have progressed or relapsed after standard platinum-based treatment.
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