AstraZeneca

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceuticals/biotech despite market fluctuations. Notable 2024 deals include Fosun's $1.71B acquisition of Shanghai Henlius Biotech, Johnson & Johnson's $850M purchase of Proteologix, and Novartis' acquisition of SanReno Therapeutics. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also gaining significance. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.

AstraZeneca and Daiichi Sankyo submitted a BLA to the FDA for accelerated approval of datopotamab deruxtecan (Dato-DXd) in previously treated, advanced EGFR-mutated NSCLC, based on TROPION-Lung05 Phase II trial results. The companies withdrew a previous BLA for Dato-DXd in advanced or metastatic nonsquamous NSCLC.

Selumetinib (Koselugo) significantly improved objective response rate (ORR) in adults with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN), meeting the primary endpoint of the phase 3 KOMET trial. Data will be presented at an upcoming medical meeting and shared with global health authorities. The FDA previously approved selumetinib for pediatric NF1 patients with PN, but no therapeutic options exist for adult patients, who make up 70% of NF1 cases.

The FDA received a new BLA for datopotamab deruxtecan (Dato-DXd) for advanced NSCLC with EGFR mutations, supported by phase 2 TROPION-Lung05 data showing 43.6% ORR and 82.1% DCR. AstraZeneca and Daiichi Sankyo withdrew the BLA for nonsquamous NSCLC, previously accepted in February 2024. TROPION-Lung01 data showed Dato-DXd's potential benefit, especially for EGFR-mutated patients, informing the new BLA submission.

KOMET trial results show Koselugo, an oral MEK inhibitor, met primary endpoint with significant objective response rate in adults with NF1 and symptomatic, inoperable plexiform neurofibromas. No new safety signals identified, consistent with previous trials. Data to be shared with regulatory authorities.

AI in healthcare is booming, with Mayo Clinic and Elon Musk's Grok AI leading the charge. Major tech companies like Nvidia, Google, and Microsoft showcased healthcare AI tools at the HLTH conference. Avant Technologies and Ainnova Tech formed a joint venture to advance early disease detection using AI, targeting a $67.4 billion market by 2027. Other companies like Recursion Pharmaceuticals, Exscientia, Absci Corporation, and Twist Bioscience are also making strides in AI-driven healthcare innovations.

AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan (Dato-DXd) for EGFR-mutated NSCLC, withdrawing a previous BLA for nonsquamous NSCLC based on FDA feedback. The new BLA is supported by TROPION-Lung05 Phase II trial data and will be presented at ESMO Asia 2024.

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.