AstraZeneca

The global drug discovery market is projected to grow from USD 60.9 billion in 2024 to USD 138.5 billion by 2033, driven by AI, high throughput screening, and R&D investments. The US market, valued at USD 25.0 billion in 2024, is expected to reach USD 54.5 billion by 2033. Key players include Pfizer, Roche, and AstraZeneca, focusing on precision medicine and AI-driven drug development.

AstraZeneca and Daiichi Sankyo submitted a Biologics License Application for accelerated US approval of datopotamab deruxtecan to treat EGFR-mutated NSCLC in adults post-systemic therapies. Supported by TROPION-Lung05 Phase II, TROPION-Lung01 Phase III, and TROPION-PanTumor01 Phase I trials, it shows promise for EGFR-mutated patients. Datopotamab deruxtecan, a TROP2-directed DXd antibody drug conjugate, offers hope against resistant EGFR-mutated NSCLC.

Jee J et al. report on a study published in *Nat Med.* 2022, focusing on various authors' contributions to the field, with Li BT being one of the key contributors.

GRAIL, Inc. announced the first patient tested with its investigational Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the TROPION-Lung12 Phase 3 study, sponsored by AstraZeneca in collaboration with Daiichi Sankyo. The study aims to evaluate adjuvant treatment regimens in Stage I adenocarcinoma NSCLC patients, using GRAIL's methylation platform to detect ctDNA without requiring tissue analysis.

T.C.-F.Y. advises and speaks for Gilead Sciences. G.L.-H.W. advises AstraZeneca, Gilead Sciences, GlaxoSmithKline, Janssen, Virion Biotherapeutics, speaks for Abbott, AbbVie, Ascletis, Bristol-Myers Squibb, Echosens, Ferring, Gilead Sciences, GlaxoSmithKline, Janssen, Roche, and received a research grant from Gilead Sciences.

Teva Pharmaceuticals and AI-driven Immunai partner to optimize immunology and immuno-oncology clinical trials using Immunai’s immune cell atlas, AMICA, and AI model, IDE. Focus areas include drug mechanism of action, dose selection, and biomarker analyses, with potential expansion to broader R&D aspects.

AstraZeneca's Tagrisso receives CHMP recommendation for treating EGFR-mutated NSCLC, based on LAURA trial results showing significant PFS extension. Tagrisso's safety profile remains consistent, with no new concerns. AstraZeneca reports strong financial growth, including a 21% revenue increase and $3.5 billion investment in U.S. manufacturing and R&D.

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Medicines Agency's CHMP recommended approval of Lazcluze with Rybrevant for EGFR-mutated advanced NSCLC. The CHMP also recommended a Type II indication extension for amivantamab in the same combination. These recommendations are supported by the Phase III MARIPOSA study, which showed a 30% reduction in disease progression or death compared to Tagrisso, with a median progression-free survival of 23.7 months versus 16.6 months for Tagrisso.

AstraZeneca's Tagrisso recommended for EU approval by CHMP for unresectable EGFR-mutated lung cancer, based on LAURA Phase III trial showing extended median progression-free survival to over three years.