Daiichi Sankyo Launches First-in-Class B7-H3 ADC Ifinatamab Deruxtecan into Phase III Trial for Recurrent Small Cell Lung Cancer

On January 12, the clinicaltrials.gov website showed that Daiichi Sankyo had initiated the Phase III clinical trial (IDeate-2) of DS-7300 (ifinatamab deruxtecan, I-DXd). This drug is the first B7H3 ADC to enter the Phase III stage.

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).

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 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 grade 2 adverse event (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.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Highlights

Live Streaming