DAIICHI SANKYO S/ADR - DSNKY STOCK NEWS

Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has received validation from the European Medicines Agency (EMA) for a Type II Variation application. This approval is for treating adult patients with unresectable or metastatic HER2 low breast cancer who have undergone prior systemic therapy. Results from the DESTINY-Breast04 trial indicated significant improvements in progression-free and overall survival compared to standard chemotherapy. The application marks a potential shift in treatment options for patients with low HER2 expression, expanding the reach of targeted therapy.

Daiichi Sankyo announced the dosing of the first patient in the global TROPION-Breast02 phase 3 trial for datopotamab deruxtecan (Dato-DXd). This trial will evaluate the efficacy and safety of Dato-DXd versus chemotherapy in patients with untreated, locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which constitutes 10-15% of breast cancers. The trial aims to improve survival rates for TNBC patients in need of alternative treatments.

Daiichi Sankyo presented initial findings from the first-in-human phase 1 study of DS-6000, a CDH6-directed DXd antibody drug conjugate (ADC), at the ASCO Annual Meeting. This trial involves patients with advanced ovarian cancer and renal cell carcinoma exhibiting disease progression after standard treatments. The results indicate early clinical activity, with a dose expansion phase now enrolling patients. Preliminary data showed partial responses in some patients, although treatment-related adverse events were observed, including grade 3 neutropenia.

Daiichi Sankyo and AstraZeneca's ENHERTU has shown promising results in the DESTINY-Breast04 trial, enhancing median overall survival by over 6 months compared to chemotherapy for patients with HER2 low metastatic breast cancer. Key findings include a 49% reduction in disease progression or death risk and a median progression-free survival of 10.1 months. The treatment demonstrated a confirmed overall response rate of 52.6%, significantly higher than chemotherapy's 16.3%. The safety profile remains consistent, with most adverse events being manageable.

Daiichi Sankyo's recent data from two early-stage trials of patritumab deruxtecan (HER3-DXd) showed promising results in treating HER3 expressing metastatic breast cancer and advanced non-small cell lung cancer (NSCLC). The findings, presented at the ASCO Annual Meeting, indicated a confirmed objective response rate (ORR) of 30.1% in patients with HR positive/HER2 negative breast cancer and 28.6% in NSCLC patients with non-EGFR mutations. Safety assessments noted treatment-related Grade ≥ 3 adverse events in 65.9% of breast cancer trial participants, highlighting the need for further exploration.

Daiichi Sankyo and AstraZeneca’s ENHERTU has received FDA approval for earlier use in treating HER2 positive metastatic breast cancer. The approval follows the DESTINY-Breast03 trial, proving ENHERTU reduces disease progression or death risk by 72% compared to T-DM1. With a median progression-free survival not reached for ENHERTU versus 6.8 months for T-DM1, this milestone expands treatment options for patients. Additionally, a milestone payment of $100 million is due from AstraZeneca to Daiichi Sankyo following this approval.

Daiichi Sankyo and AstraZeneca's ENHERTU has received its fifth Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with unresectable or metastatic HER2 low breast cancer. This designation follows positive results from the DESTINY-Breast04 trial, which demonstrated significant improvements in progression-free survival and overall survival compared to standard chemotherapy. The safety profile of ENHERTU remains consistent with previous trials. This designates ENHERTU as a potential game-changer for patients with lower HER2 expression, addressing a critical unmet medical need.

Daiichi Sankyo and AstraZeneca announced that their sBLA for ENHERTU, a HER2-targeted therapy for metastatic non-small cell lung cancer, has been accepted by the FDA for Priority Review. Based on the DESTINY-Lung01 trial, ENHERTU achieved a remarkable 54.9% tumor response rate and a confirmed disease control rate of 92.3%. The median overall survival was 17.8 months, promising for patients with HER2 mutations. This therapy marks a significant advancement, as currently, no HER2 directed therapies exist for this specific cancer type.

Daiichi Sankyo Co., Ltd. announced that a jury found its drug ENHERTU^® infringes Seagen's US patent 10,808,039, awarding Seagen $41.82 million in damages. The U.S. Patent Office is reviewing this patent after Daiichi Sankyo contested its validity. The court has not ruled on Seagen's request for additional royalties on future ENHERTU^® sales until the patent's expiry in 2024. Daiichi Sankyo is committed to appealing the verdict and exploring options regarding the jury's decision.