DAIICHI SANKYO, INC.

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NSCLC with HER2 mutations, found in 3% of advanced non-squamous cases, is associated with poor prognosis and higher incidence of brain metastases. Standard first-line chemotherapy has limited efficacy, and HER2-targeted agents lag in NSCLC treatment. Recent studies using HER2 TKIs, ADCs, and monoclonal antibodies show promising results, with Trastuzumab deruxtecan (T-DXd) achieving 55% ORR and 8.2 months mPFS in DESTINY-Lung01 trial. Zongertinib, a novel HER2-specific TKI, demonstrated 62% ORR and 97% DCR in HER2 mutation-positive NSCLC patients, with low toxicity rates, suggesting a potential better tolerated treatment option.

The FDA granted priority review to a supplemental Biologics License Application for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for treating adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer after at least one endocrine therapy. The application is supported by results from the phase IIIDESTINY-Breast06 trial, which demonstrated a median progression-free survival of 13.2 months for T-DXd versus 8.1 months for chemotherapy. T-DXd was previously granted Breakthrough Therapy Designation for this setting.

DESTINY-Breast06 trial evaluates Enhertu vs. chemotherapy in HR-positive, HER2-low/ultralow metastatic breast cancer. Enhertu, a HER2-directed ADC, is approved for various HER2-positive and HER2-low cancers. AstraZeneca and Daiichi Sankyo collaborate on Enhertu's development and commercialization.

Transthyretin amyloidosis cardiomyopathy drug development, including Pfizer's Vyndamax and BridgeBio's acoramidis, is a major focus. FDA decisions on acoramidis, AstraZeneca's dato-dxd for lung cancer, Vertex's vanza triple for cystic fibrosis, PTC's Upstaza for AADC deficiency, and Bristol Myers' subcutaneous Opdivo for solid tumors are imminent, with significant market implications.

ENHERTU granted Priority Review in the US for HER2-low or HER2-ultralow metastatic breast cancer patients who have received at least one line of endocrine therapy, based on the DESTINY-Breast06 Phase III trial demonstrating significant progression-free survival benefit. If approved, ENHERTU would be the first HER2-directed therapy and ADC for patients prior to chemotherapy. ENHERTU also received Breakthrough Therapy Designation for this patient population.

August 2024 biopharma deals highlight trends in bispecific T-cell engagers, CD-19 targeting in autoimmune diseases, and Chinese biopharma innovation. Merck's $1.3B acquisition of Curon's CD3xCD19 BiTE CN201 reflects confidence in early trial outcomes and market enthusiasm for BiTEs. JPMorgan reports a 50% reduction in upfront payments since 2020, indicating a more back-loaded deal structure.

AstraZeneca's Tagrisso (osimertinib) approved in the US for treating unresectable, Stage III EGFRm NSCLC, reducing disease progression risk by 84% compared to placebo. The approval is based on the LAURA phase III trial results, showing a median PFS of 39.1 months with Tagrisso versus 5.6 months for placebo. The trial continues to assess overall survival.

FDA approves AstraZeneca's Tagrisso for unresectable, Stage III EGFR-mutated lung cancer, based on LAURA Phase III trial results showing 84% reduction in disease progression risk.

Lung cancer, a leading cause of cancer death globally, affects 2.4 million annually. TAGRISSO (osimertinib), a third-generation EGFR-TKI, is pivotal in treating EGFRm NSCLC, with extensive evidence supporting its use across various stages. AstraZeneca continues to innovate in lung cancer treatment, aiming to improve outcomes and redefine care.