DAIICHI SANKYO S/ADR - DSNKY STOCK NEWS

Compugen has announced that it will receive a $5 million milestone payment from AstraZeneca following the dosing of the first patient in the Phase 3 TROPION-Lung10 trial. This trial evaluates the efficacy and safety of rilvegostomig, a PD-1/TIGIT bispecific antibody, as monotherapy and in combination with datopotamab deruxtecan for first-line treatment of non-squamous non-small cell lung cancer patients with high PD-L1 expression. The trial is expected to enroll approximately 675 patients across 14 countries. This milestone is part of Compugen's strategy to expand its pipeline through partnerships, following a previous $10 million payment related to the ARTEMIDE-Biliary01 Phase 3 trial.

Daiichi Sankyo announced an FDA extension for the New Drug Application (NDA) of quizartinib, now due on July 24, 2023. This extension allows additional time for reviewing updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) without new efficacy or safety data requests. Quizartinib shows promise in treating adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, as demonstrated in the QuANTUM-First trial, which highlighted improved overall survival rates when combined with standard chemotherapy. The trial enrolled 539 patients across multiple regions, emphasizing the significance of the product in potentially changing the standard of care for AML patients.

Daiichi Sankyo presented updated results from phase 1 trials of patritumab deruxtecan, a potential first-in-class HER3-directed antibody drug conjugate, during the JSMO 2023 meeting. Key findings showed a 40.2% objective response rate (ORR) in 102 heavily pretreated patients with EGFR-mutated metastatic non-small cell lung cancer (NSCLC), and promising activity in HER3 expressing metastatic breast cancer. Median overall survival was reported at 15.8 months for NSCLC patients. The safety profile aligned with previous findings, although treatment-related adverse events were noted in 56.9% of patients. These data suggest patritumab deruxtecan may provide new treatment options for difficult-to-treat cancers.

Daiichi Sankyo and AstraZeneca announced positive topline results from the DESTINY-PanTumor02 phase 2 trial of ENHERTU (trastuzumab deruxtecan), demonstrating that the treatment met pre-specified objectives for objective response rate (ORR) and duration of response (DoR) across various HER2 expressing advanced solid tumors.

The trial targets heavily pre-treated patients with locally advanced, unresectable, or metastatic tumors, and its findings will be presented at an upcoming medical meeting. The data is crucial for informing further development programs, as ENHERTU shows promise in addressing significant unmet medical needs in multiple cancer types.

Daiichi Sankyo Co., Ltd. (TSE: 4568) announced that the U.S. Patent and Trademark Office has granted its request to reinstitute post-grant review of the patentability of Seagen’s U.S. patent 10,808,039. Corporate Officer Naoto Tsukaguchi expressed satisfaction with the PTO’s decision, citing compelling evidence of the patent's unpatentability. This review follows a petition filed by Daiichi Sankyo on December 23, 2020, and previous actions by the PTO, including a rehearing request by Seagen. The result of this review could significantly impact Daiichi Sankyo's competitive position in the oncology sector.

Daiichi Sankyo announces the availability of a new dosing regimen for TURALIO® (pexidartinib) in the U.S., intended for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) unresponsive to surgery. The 125 mg capsule replaces the discontinued 200 mg version, with the recommended dose now 250 mg orally twice daily with a low-fat meal. Studies revealed that this new regimen maintains efficacy while minimizing the risk of hepatotoxicity, previously observed with higher fat consumption. TURALIO carries a Boxed WARNING due to severe liver injury risks, mandating a restricted distribution program.

Daiichi Sankyo announced the dosing of the first patient in the global, randomized TROPION-Lung07 phase 3 trial, evaluating datopotamab deruxtecan in combination with pembrolizumab, with or without chemotherapy, for patients with untreated non-small cell lung cancer (NSCLC). This trial targets patients with PD-L1 expression less than 50% and aims to improve treatment outcomes for a patient group that faces significant disease progression with current therapies. The study will enroll approximately 975 patients and assess primary endpoints such as progression-free survival (PFS) and overall survival.

Daiichi Sankyo and AstraZeneca have received EU approval for ENHERTU (trastuzumab deruxtecan) to treat adults with HER2 low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. The therapy significantly reduced disease progression or death risk by 50% and increased median overall survival by over six months compared to chemotherapy. Approval is based on the pivotal DESTINY-Breast04 trial results, reinforcing ENHERTU as a potential new standard of care. Following this, AstraZeneca is due to pay $150 million to Daiichi Sankyo as a milestone payment.

Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations. The validation triggers the scientific review process based on results from the DESTINY-Lung01 and DESTINY-Lung02 trials, which showed significant tumor response. ENHERTU currently has multiple approvals in various countries, and this application aims to expand its use in Europe.