DAIICHI SANKYO S/ADR - DSNKY STOCK NEWS

Daiichi Sankyo and AstraZeneca’s ENHERTU has gained U.S. FDA approval for treating unresectable or metastatic non-small cell lung cancer (NSCLC) in patients with HER2 mutations after prior therapy. The decision is based on the DESTINY-Lung02 trial, showing a confirmed objective response rate of 57.7%. This approval marks the third tumor type for ENHERTU, emphasizing its significance. The FDA also approved diagnostic tests for HER2 mutations, enhancing treatment access. AstraZeneca will pay Daiichi Sankyo $125 million as a milestone payment related to this approval.

Daiichi Sankyo announced the dosing of the first patient in the global HERTHENA-Lung02 phase 3 trial, assessing patritumab deruxtecan against chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) patients. The trial aims to evaluate the drug's efficacy and safety after prior treatment failures. Patritumab deruxtecan is a novel HER3-directed antibody drug conjugate, with a primary endpoint of progression-free survival. This trial involves approximately 560 patients across multiple regions, showcasing Daiichi Sankyo's commitment to improving treatment options in oncology.

Daiichi Sankyo and AstraZeneca announced that the FDA has approved ENHERTU for adult patients with unresectable or metastatic HER2 low breast cancer. This decision follows the successful DESTINY-Breast04 trial, which showed ENHERTU reduced disease progression or death by 50% and offered a median overall survival of 23.9 months compared to 17.5 months with chemotherapy. AstraZeneca will pay Daiichi Sankyo $200 million as a milestone payment following this approval. ENHERTU's safety includes warnings for interstitial lung disease and embryo-fetal toxicity.

Daiichi Sankyo and AstraZeneca announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for ENHERTU, a HER2-directed therapy for metastatic breast cancer. This application received Priority Review status due to its potential to significantly improve treatment outcomes. ENHERTU demonstrated survival benefits in the DESTINY-Breast04 trial, marking a breakthrough for patients with HER2 low breast cancer. The FDA's decision is expected in Q4 2022 under the Real-Time Oncology Review and Project Orbis initiatives.

Daiichi Sankyo announced the initiation of a global phase 2 trial for DS-7300, an investigational antibody drug conjugate targeting B7-H3, in patients with pretreated extensive-stage small cell lung cancer (SCLC). Given the poor prognosis associated with SCLC, with a 5-year survival rate of just 3% for extensive-stage cases, this trial aims to evaluate the drug's efficacy and safety. Approximately 80 patients across Asia, Europe, and North America will be enrolled, comparing two dosing regimens. The results could address significant unmet medical needs in this patient population.

Daiichi Sankyo Co., Ltd. confirmed that the U.S. District Court for the Eastern District of Texas upheld a jury's April 8, 2022, finding of willful patent infringement involving ENHERTU® and awarded $41.8 million in damages to Seagen. However, the Court did not enhance the damages despite the willfulness finding. Daiichi Sankyo intends to contest the judgment and assess any financial impact for the fiscal year ending March 31, 2023, because the Court has yet to rule on potential running royalties on future ENHERTU® sales until the patent expiration in 2024.

Daiichi Sankyo and AstraZeneca's ENHERTU has received EU approval as a monotherapy for adults with unresectable or metastatic HER2 positive breast cancer, marking an earlier treatment option based on the DESTINY-Breast03 trial. This pivotal phase 3 trial showed a remarkable 72% reduction in disease progression or death risk compared to trastuzumab emtansine. The approval extends market protection for ENHERTU by one year, affirming its significant clinical benefits. AstraZeneca is due to pay Daiichi Sankyo $75 million as a milestone for this approval.

Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has gained a positive recommendation from the European Medicines Agency for treating HER2 positive metastatic breast cancer. This recommendation is based on the DESTINY-Breast03 trial, which demonstrated a 72% reduction in disease progression risk compared to T-DM1. The therapy's safety profile aligns with previous studies, and the European Commission will now evaluate this recommendation. With over 530,000 breast cancer diagnoses in Europe annually, there is a critical need for effective treatment options.