Astrazeneca Plc Stock Price, News & Analysis

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.

AstraZeneca announced a total of $4 million in financial contributions to 52 nonprofit organizations through its second annual Accelerate Change Together (ACT) on Health Equity. The funds aim to enhance health equity and promote STEM among underrepresented communities in the US. Out of over 1,000 applications, 38 community-based nonprofits will receive $25,000 each. Additionally, 14 national nonprofits will share $3 million for health equity programs.

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.

AstraZeneca presented SERENA-2 Phase II trial results at the 2022 San Antonio Breast Cancer Symposium. The trial evaluated camizestrant, a next-generation oral selective estrogen receptor degrader, showing a 42% reduction in disease progression risk at 75mg and a 33% reduction at 150mg compared to FASLODEX in post-menopausal patients with ER-positive advanced breast cancer. The median progression-free survival was 7.2 months for 75mg and 7.7 months for 150mg, highlighting camizestrant's potential for improved patient outcomes.

AstraZeneca announced positive results from the Phase III CAPItello-291 trial for capivasertib, an investigational AKT inhibitor, in combination with FASLODEX. This treatment significantly improved progression-free survival (PFS) by 40% in the overall population and 50% in patients with AKT pathway alterations. Median PFS was 7.2 months versus 3.6 months for placebo. The objective response rate (ORR) was 22.9% compared to 12.2% for placebo. Safety profiles were consistent with prior trials. The trial enrolled 708 patients, targeting advanced HR-positive, HER2-low or negative breast cancer.

AstraZeneca and Daiichi Sankyo announced updated results for ENHERTU in the DESTINY-Breast03 Phase III trial, showing a 36% reduction in risk of death compared to T-DM1 in HER2-positive breast cancer patients, with median overall survival not yet reached after 28.4 months. Additionally, ENHERTU demonstrated a 22-month improvement in progression-free survival (PFS) over T-DM1. The safety profile remained consistent with previous trials, with no new concerns. The findings support ENHERTU as the potential new standard of care for previously treated HER2-positive metastatic breast cancer.

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.