Datroway (datopotamab deruxtecan-dlnk)

These findings highlight the need for larger, prospective studies to define optimal management strategies for ADC-induced OM.

P3, N=644, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Nov 2028

P3, N=24, Active, not recruiting, AstraZeneca | N=660 --> 24 | Trial completion date: Jan 2035 --> Jun 2027 | Trial primary completion date: May 2033 --> Jun 2027 | Recruiting --> Active, not recruiting

P4, N=100, Not yet recruiting, AstraZeneca

P3, N=625, Recruiting, AstraZeneca | Trial completion date: Apr 2029 --> Sep 2030 | Trial primary completion date: Oct 2026 --> Jul 2027

P3, N=1170, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting

The success of inhibitors like sotorasib and adagrasib has expanded options for targeting once 'undruggable' oncogenic drivers such as KRAS...ADCs such as EMRELIS™, Datroway, and ELAHERE™ offer precise targeting along with potent cytotoxic agents...Cancer vaccine research is progressing with licensed immunoprophylactic drugs, and AI tools like AlphaFold are speeding up drug discovery by enhancing structural biology predictions. This review covers recent cancer therapeutics advancements, including targeted inhibitors, immunotherapies, resistance strategies, epigenetic interventions, combination therapies, vaccines, and AI applications.

P3, N=744, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting

The addition of osimertinib to curative-intent strategies have demonstrated improvements in disease-free survival and overall survival (OS) as adjuvant therapy in resected stage IB-IIIa patients, major pathological responses compared to chemotherapy when used as neoadjuvant therapy, and progression-free survival (PFS) compared to placebo when used as consolidation therapy in unresectable stage III patients. Currently, subsequent treatment recommendations include chemotherapy or datopotamab deruxtecan following progression on a third-generation EGFR-TKI combination and amivantamab plus platinum-based chemotherapy following progression on monotherapy. The treatment landscape for NSCLC with common EGFR mutations is rapidly evolving and third-generation EGFR-TKIs play an integral role in both the curative-intent and palliative settings.

Data from this study could lead to a new treatment option in this setting. ClinicalTrials.gov identifier: NCT06417814 (date of registration: May 13, 2024).

Dato-DXd demonstrates encouraging antitumor activity and a manageable safety profile in several advanced solid tumors, particularly breast cancer and NSCLC. This synthesis provides a valuable evidence base to guide clinical practice and future trial design. However, as the current evidence is predominantly from early phase and single-arm studies, confirmation through large-scale randomized controlled trials is necessary before Dato-DXd can be widely adopted in clinical practice.

TROPION-Breast01 met its dual primary endpoint of PFS by BICR. While there was no statistically significant improvement in the dual primary endpoint of OS with Dato-DXd versus ICC, subsequent ADC treatment may have affected OS results. The totality of efficacy and safety data support Dato-DXd as a new treatment option for patients with previously treated, inoperable/metastatic HR+/HER2‒ breast cancer.