On January 12, the clinicaltrials.gov website showed that Daiichi Sankyo initiatedDS-7300（ifinatamab deruxtecan，I-DXd) Phase III Clinical Trial (IDeate-2）. This drug is the first to enter the Phase III stage.B7H3 ADC。I-DXd is the first Daiichi-Sankyo based on itsA B7H3 ADC developed using the DXd ADC technology platform, and also a project co-developed with Merck, similar to HER3-DXd (HER3 ADC) and R-DXd (CDH6 ADC).IDeate-2 is a multicenter, randomized, open-label study planned to enroll 468 patients, aiming to evaluate the efficacy and safety of I-DXd versus physician's choice (PC) in treating patients with recurrent small cell lung cancer (SCLC). The primary endpoints are objective response rate (ORR) and overall survival (OS).
In September 2023, Daiichi-Sankyo announced I-DXd（6.4-16.0mg/kg）Results of a Phase I/II study in patients with advanced SCLC who received a median of two prior lines of therapy. The results showed that, among 21 patients with advanced SCLC 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.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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