AstraZeneca

Datopotamab deruxtecan, an investigational TROP2-directed ADC, is being evaluated in multiple clinical trials for advanced NSCLC, including TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01. These trials assess efficacy and safety in patients with actionable genomic alterations and those requiring systemic therapy following prior treatment. Primary endpoints include objective response rate (ORR) and progression-free survival (PFS). AstraZeneca and Daiichi Sankyo collaborate on the development and commercialization of datopotamab deruxtecan.

AstraZeneca and Daiichi Sankyo submitted a new BLA to the FDA for datopotamab deruxtecan (dato-DXd) as a therapy for previously treated non–small cell lung cancer (NSCLC) with EGFR mutations. The BLA is based on findings from the phase 2 TROPION-Lung05 study and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials. The decision to seek accelerated approval was informed by pronounced benefits observed in EGFR-mutant patients.

AstraZeneca and Daiichi Sankyo withdrew an approval application for lung cancer drug dato-dxd, replacing it with a new one targeting EGFR-mutated tumors, aiming for an 'accelerated' approval in previously treated patients. This decision, based on pooled analysis showing pronounced benefit in EGFR-mutated patients, could limit the drug's sales potential.

AstraZeneca resubmits Dato-DXd for U.S. approval in a different form of lung cancer, delaying market entry and raising questions about its potential use. The drug, a next-generation chemotherapy, did not outperform standard chemotherapy in overall survival trials.

Koselugo demonstrated a statistically significant and clinically meaningful objective response rate vs. placebo in adults with neurofibromatosis type 1 in the global KOMET Phase III trial, showing reduction in tumour volume and consistent safety profile, supporting its expanded use in adults.

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NF1 is a genetic condition causing soft lumps and tumours on nerve sheaths. KOMET trial evaluates Koselugo, a kinase inhibitor for NF1 patients with inoperable PNs. Koselugo, approved in multiple countries, blocks MEK1 and MEK2 enzymes to slow PN growth. AstraZeneca and MSD collaborate on co-developing Koselugo and Lynparza.

Show Chwan Health Care System signs MOU with Novotech, a CRO, to enhance clinical trial capabilities in Changhua and Tainan. The partnership aims to bring the latest treatment technologies to doctors and patients, while ensuring subject protection through IRB and HRPC. Novotech, with over 5,000 trial projects and 34% in Phase I and II, will focus on clinical trial development and education.

AstraZeneca raised its annual forecast due to strong cancer drug sales and plans $3.5B investment in US by 2026. Tagrisso and Enhertu outperformed, while Dato-DXd faced FDA setback. China sales growth slowed amid import probe. Astra aims for $80B in sales by 2030, driven by cancer drugs.

AstraZeneca announced positive KOMET Phase III trial data for Koselugo, showing significant response rate in adults with neurofibromatosis type 1. The trial met its primary endpoint, reducing tumour volume, and the safety profile was consistent with previous trials. Alexion, AstraZeneca Rare Disease plans to share these results with regulatory authorities and present them at a medical meeting.