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AZN Stock Slips as Dato-DXd Cancer Study Misses Survival Goal
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AstraZeneca (AZN - Free Report) and Japanese partner Daiichi Sankyo announced that their antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to achieve statistical significance in the final overall survival (OS) analysis in a study for a metastatic breast cancer indication.
The TROPION-Breast01 phase III study evaluated Dato-DXd,a TROP2-directed ADC for treating inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study compared Dato-DXd to the investigator’s choice of chemotherapy. The study had previously met the dual primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement in PFS.
AstraZeneca/Daiichi’s biologics license application (BLA) seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer is already under review in the United States based on PFS data from the TROPION-Breast01 phase III study. The FDA is expected to give its decision on the BLA in the first quarter of 2025. AstraZeneca & Daiichi have separate studies ongoing for Dato-DXd for triple-negative or HR-low, HER2-negative breast cancers.
AstraZeneca’s stock declined 1.6% on Monday in response to the pipeline setback. The overall survival miss lowers the drug’s chances for approval in the breast cancer indication, which explains the stock’s decline.
AstraZeneca’s stock has risen 14.5% so far this year compared with an increase of 23.5% for the industry.
Image Source: Zacks Investment Research
AZN/Daiichi Dato-DXd for Lung Cancer
Dato-DXd is being jointly developed by AstraZeneca and Daiichi Sankyo. AstraZeneca/Daiichi Sankyo are also seeking approval of Dato-DXd for advanced nonsquamous non-small cell lung cancer (NSCLC). A BLA for the NSCLC indication is under review with the FDA. The BLA is based on data from the pivotal TROPION-Lung01 phase III study. The FDA is expected to give its decision on the NSCLC BLA in the fourth quarter of 2024. Regulatory applications for Dato-DXd in lung and breast cancer are underway in several other countries, including the EU, China and Japan.
Other Companies Making ADC Drugs
Antibody-drug conjugates or ADCs like Dato-DXd are being considered a disruptive innovation in the pharmaceutical industry as these have the potential to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Gilead (GILD - Free Report) also has a Trop-2-directed ADC in its portfolio called Trodelvy, which is approved in several countries, including the United States and EU, for treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adult patients who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer in some countries, including the United States and the EU. In the United States, Gilead’s Trodelvy received accelerated approval for the treatment of certain patients with second-line metastatic urothelial cancer.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancers, being developed utilizing its DXd ADC technology. In addition to Dato-DXd, Daiichi markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca.
Daiichi and Merck (MRK - Free Report) are co-developing and co-commercializing three ADCs, patritumab deruxtecan/MK-1022, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400. While Merck/Daiichi’s patritumab deruxtecan is under review in the United States for previously treated EGFR-mutated NSCLC, raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer. Ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.
The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Pfizer (PFE - Free Report) also has a strong portfolio of ADC drugs, which were added with last year’s acquisition of Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio. Adcetris, Padcev, Tukysa and Tivdak contributed $279 million, $394 million, $121 million and $33 million, respectively, to Pfizer’s oncology revenues in the second quarter. Pfizer is particularly witnessing strong demand for Padcev.
Image: Bigstock
AZN Stock Slips as Dato-DXd Cancer Study Misses Survival Goal
AstraZeneca (AZN - Free Report) and Japanese partner Daiichi Sankyo announced that their antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to achieve statistical significance in the final overall survival (OS) analysis in a study for a metastatic breast cancer indication.
The TROPION-Breast01 phase III study evaluated Dato-DXd,a TROP2-directed ADC for treating inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study compared Dato-DXd to the investigator’s choice of chemotherapy. The study had previously met the dual primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement in PFS.
AstraZeneca/Daiichi’s biologics license application (BLA) seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer is already under review in the United States based on PFS data from the TROPION-Breast01 phase III study. The FDA is expected to give its decision on the BLA in the first quarter of 2025. AstraZeneca & Daiichi have separate studies ongoing for Dato-DXd for triple-negative or HR-low, HER2-negative breast cancers.
AstraZeneca’s stock declined 1.6% on Monday in response to the pipeline setback. The overall survival miss lowers the drug’s chances for approval in the breast cancer indication, which explains the stock’s decline.
AstraZeneca’s stock has risen 14.5% so far this year compared with an increase of 23.5% for the industry.
Image Source: Zacks Investment Research
AZN/Daiichi Dato-DXd for Lung Cancer
Dato-DXd is being jointly developed by AstraZeneca and Daiichi Sankyo. AstraZeneca/Daiichi Sankyo are also seeking approval of Dato-DXd for advanced nonsquamous non-small cell lung cancer (NSCLC). A BLA for the NSCLC indication is under review with the FDA. The BLA is based on data from the pivotal TROPION-Lung01 phase III study. The FDA is expected to give its decision on the NSCLC BLA in the fourth quarter of 2024. Regulatory applications for Dato-DXd in lung and breast cancer are underway in several other countries, including the EU, China and Japan.
Other Companies Making ADC Drugs
Antibody-drug conjugates or ADCs like Dato-DXd are being considered a disruptive innovation in the pharmaceutical industry as these have the potential to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Gilead (GILD - Free Report) also has a Trop-2-directed ADC in its portfolio called Trodelvy, which is approved in several countries, including the United States and EU, for treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adult patients who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer in some countries, including the United States and the EU. In the United States, Gilead’s Trodelvy received accelerated approval for the treatment of certain patients with second-line metastatic urothelial cancer.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancers, being developed utilizing its DXd ADC technology. In addition to Dato-DXd, Daiichi markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca.
Daiichi and Merck (MRK - Free Report) are co-developing and co-commercializing three ADCs, patritumab deruxtecan/MK-1022, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400. While Merck/Daiichi’s patritumab deruxtecan is under review in the United States for previously treated EGFR-mutated NSCLC, raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer. Ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.
The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Pfizer (PFE - Free Report) also has a strong portfolio of ADC drugs, which were added with last year’s acquisition of Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio. Adcetris, Padcev, Tukysa and Tivdak contributed $279 million, $394 million, $121 million and $33 million, respectively, to Pfizer’s oncology revenues in the second quarter. Pfizer is particularly witnessing strong demand for Padcev.
AZN’s Rank
AstraZeneca has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AstraZeneca PLC Price and Consensus
AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote