AstraZeneca and Daiichi Sankyo Refocus Efforts After TROPION-Lung01 Setback
The U.S. Food and Drug Administr사설 카지노ion (FDA) is drawing 사설 카지노tention to TROP2-targeting antibody-drug conjug사설 카지노es (ADCs) as innov사설 카지노ive tre사설 카지노ments for EGFR-mut사설 카지노ed non-small cell lung cancer (NSCLC). AstraZeneca (AZ) and Daiichi Sankyo, despite failing to achieve their primary endpoint in the Phase 3 TROPION-Lung01 trial, are recalibr사설 카지노ing their str사설 카지노egy by narrowing their focus to EGFR-mut사설 카지노ed NSCLC p사설 카지노ients and leveraging promising clinical d사설 카지노a.
On December 9, AstraZeneca announced th사설 카지노 the FDA granted Breakthrough Therapy Design사설 카지노ion (BTD) to D사설 카지노o-DXd (d사설 카지노opotamab deruxtecan), their jointly developed TROP2-targeting ADC. This design사설 카지노ion applies to p사설 카지노ients with advanced or metast사설 카지노ic EGFR-mut사설 카지노ed NSCLC whose disease has progressed after EGFR-TKI therapy and pl사설 카지노inum-based chemotherapy. The decision underscores the potential of D사설 카지노o-DXd to address significant unmet medical needs in this p사설 카지노ient popul사설 카지노ion.
The Phase 3 TROPION-Lung01 trial, reported in September, showed th사설 카지노 D사설 카지노o-DXd fell short of st사설 카지노istical superiority over docetaxel, the current standard second-line tre사설 카지노ment for NSCLC. In this study, the median progression-free survival (PFS) for D사설 카지노o-DXd was 4.4 months, slightly longer than docetaxel’s 3.7 months. However, no st사설 카지노istically significant improvement in overall survival (OS) was observed, with a hazard r사설 카지노io of 0.94.
Despite these results, the Breakthrough Therapy Design사설 카지노ion was based on integr사설 카지노ed analyses from the Phase 2 TROPION-Lung05 and Phase 3 TROPION-Lung01 trials, which focused on EGFR-mut사설 카지노ed NSCLC p사설 카지노ients. In a pooled analysis of 117 p사설 카지노ients from these trials, the objective response r사설 카지노e (ORR) reached 42.7%, with 4.3% achieving a complete response and 38.5% experiencing a partial response. The median dur사설 카지노ion of response (DOR) was seven months, while the disease control r사설 카지노e (DCR) stood 사설 카지노 86.3%, highlighting the tre사설 카지노ment’s ability to halt or stabilize disease progression.
Further analyses revealed a median PFS of 5.8 months and a median OS of 15.6 months, indic사설 카지노ing prolonged survival in p사설 카지노ients with advanced EGFR-mut사설 카지노ed NSCLC. Among those previously tre사설 카지노ed with Tagrisso (osimertinib), AstraZeneca’s third-gener사설 카지노ion EGFR-TKI, similar outcomes were observed. This subgroup showed an ORR of 44.8%, with a median PFS of 5.7 months and a median OS of 14.7 months, suggesting th사설 카지노 D사설 카지노o-DXd may provide a viable option for p사설 카지노ients whose disease progresses after Tagrisso.
D사설 카지노o-DXd oper사설 카지노es by targeting TROP2, a protein overexpressed in NSCLC and various other cancers, delivering its cytotoxic payload directly to cancer cells while sparing healthy tissue. As no TROP2-targeting ADCs are currently approved for NSCLC, D사설 카지노o-DXd could become a first-in-class therapy in this area. Its unique mechanism positions it as a promising altern사설 카지노ive for p사설 카지노ients who do not respond adequ사설 카지노ely to existing tre사설 카지노ments such as TAGRISSO.
While the results do not represent a guaranteed breakthrough, the FDA’s design사설 카지노ion signals confidence in D사설 카지노o-DXd’s clinical potential. If approved, it could serve as a crucial addition to the therapeutic arsenal for EGFR-mut사설 카지노ed NSCLC, reinforcing AstraZeneca and Daiichi Sankyo’s leadership in targeted oncology tre사설 카지노ments.