DAIICHI SANKYO S/ADR - DSNKY STOCK NEWS

Daiichi Sankyo and AstraZeneca's ENHERTU has been recommended for EU approval as a monotherapy for patients with unresectable or metastatic HER2 low breast cancer. The CHMP’s positive opinion is based on the DESTINY-Breast04 phase 3 trial, where ENHERTU demonstrated a 50% reduction in disease progression or death risk compared to chemotherapy. It also showed a median overall survival of 23.4 months, outperforming chemotherapy's 16.8 months. This marks ENHERTU as the first HER2 directed therapy to show significant survival benefits in this patient population.

Daiichi Sankyo and AstraZeneca's ENHERTU has been approved in the EU for treating advanced HER2 positive gastric cancer, marking the first approval for such a treatment in over a decade. This decision is based on the positive results from the DESTINY-Gastric02 and DESTINY-Gastric01 trials, which showed significant efficacy with an overall response rate of 41.8% and a median duration of response of 8.1 months in one trial. A milestone payment of $35 million is due from AstraZeneca to Daiichi Sankyo following this approval, reinforcing the financial implications for both companies.

Daiichi Sankyo and AstraZeneca reported promising results for datopotamab deruxtecan in metastatic triple negative breast cancer (TNBC). The TROPION-PanTumor01 phase 1 trial indicated a 32% objective response rate (ORR) among heavily pretreated patients. Subgroup analysis showed a 44% ORR in those not previously treated with topoisomerase I inhibitors. In the BEGONIA trial, the combination of datopotamab deruxtecan and durvalumab yielded a notable 73.6% ORR in first-line treatment. The safety profile was manageable, with no new safety signals identified.

Initial results from the TROPION-PanTumor01 phase 1 trial for datopotamab deruxtecan (Dato-DXd), jointly developed by Daiichi Sankyo and AstraZeneca, show promising efficacy in heavily pretreated hormone receptor positive, HER2 low or negative metastatic breast cancer. With a 27% objective response rate (ORR) and 85% disease control rate (DCR), the safety profile is consistent with prior studies. Further evaluation is planned in the pivotal TROPION-Breast01 phase 3 trial. These findings underscore the potential of Dato-DXd in addressing unmet needs in this patient population.

Daiichi Sankyo and AstraZeneca presented updated results from the DESTINY-Breast03 trial, showing that ENHERTU significantly improved overall survival (OS) by 36% compared to T-DM1 in HER2 positive metastatic breast cancer patients. The median OS was not reached for ENHERTU versus 34.0 months for T-DM1. Furthermore, ENHERTU offered a 22-month improvement in progression-free survival (PFS) over T-DM1 (28.8 vs 6.8 months), and a confirmed objective response rate of 78.5%. Safety profiles were consistent with prior studies, with grade 3 or higher adverse events in 47.1% of patients receiving ENHERTU.

Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency's CHMP has recommended approval of ENHERTU for treating advanced HER2 positive gastric cancer. This approval is based on positive results from the DESTINY-Gastric02 and DESTINY-Gastric01 trials, showing improved overall survival and response rates over chemotherapy. ENHERTU demonstrated a confirmed objective response rate of 41.8% in DESTINY-Gastric02 and 51.3% in DESTINY-Gastric01, with median overall survival reaching 12.1 months and 12.5 months, respectively. The European Commission will review this recommendation for final approval.

Daiichi Sankyo received FDA acceptance for the New Drug Application (NDA) of quizartinib in combination with chemotherapy for treating adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). The treatment demonstrates significantly improved overall survival compared to chemotherapy alone. The FDA granted Priority Review status, with a Prescription Drug User Fee Act date set for April 24, 2023. This follows a Fast Track Designation received in March 2022. The QuANTUM-First trial showed promise in addressing high unmet needs in AML treatment.

Daiichi Sankyo has announced the validation of its marketing authorization application for quizartinib by the European Medicines Agency (EMA). This application is based on QuANTUM-First phase 3 trial results, where quizartinib combined with chemotherapy significantly improved overall survival for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). Around 25% of AML cases carry the FLT3 mutation, associated with poor prognosis. The review process by the EMA's Committee for Medicinal Products for Human Use has commenced.

Daiichi Sankyo and AstraZeneca announced positive topline results from the DESTINY-Breast02 phase 3 trial of ENHERTU, demonstrating significant improvement in progression-free survival in patients with HER2 positive metastatic breast cancer previously treated with T-DM1. The trial met both primary and key secondary endpoints, showing improved overall survival. Safety profiles remained consistent with earlier trials, with no new safety concerns. The trial results contribute to regulatory discussions for ENHERTU's current breast cancer indication.