We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AstraZeneca's (AZN) Dato-DXd Meets Goal in Breast Cancer Study
Read MoreHide Full Article
AstraZeneca Plc (AZN - Free Report) and its Japanese counterpart, Daiichi Sankyo, announced positive results from the late-stage study evaluating datopotamab deruxtecan (Dato-DXd) in the treatment of patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. The enrolled population for this study includes previously treated patients with endocrine-based therapy and at least one systemic therapy.
Per the data readout from the TROPION-Breast01 phase III study, treatment with Dato-DXd in the enrolled patient population led to a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival compared with the investigator’s choice of chemotherapy.
AstraZeneca also reported observing an improvement trend for the co-primary endpoint of overall survival (OS) upon treatment with Dato-DXd against chemotherapy. However, at the time of the interim analysis, the OS data were not mature and the study will continue to assess the same.
The safety profile of the drug was found to be consistent with previous studies in breast cancer. No new safety signals were identified.
Dato-DXd is a TROP2-directed DXd antibody-drug conjugate, which is currently being jointly developed by AstraZeneca and Daiichi Sankyo.
Shares of AstraZeneca climbed 1.2% on Friday in response to the encouraging news. Year to date, AZN stock failed to deliver any returns against the industry’s 5.7% rise.
Image Source: Zacks Investment Research
HR-positive, HER2-low or negative breast cancer is a common subtype, which is observed in approximately 65% of diagnosed breast cancer cases. Currently, the standard-of-care first-line treatment for breast cancer patients is endocrine therapy. However, per AstraZeneca, most patients with advanced breast cancer become resilient to treatment, representing a significant unmet medical need.
Notably, AstraZeneca and Daiichi Sankyo are also currently evaluating Dato-DXd in two additional phase III studies in breast cancer. The TROPION-Breast02 study is evaluating the efficacy of Dato-DXd in comparison to chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), who are ineligible for anti-PDL1 therapy.
On the other hand, the TROPION-Breast03 study is evaluating Dato-DXd both as a monotherapy and in combination with Imfinzi (durvalumab) against the investigator’s choice of therapy in patients with stage I-III TNBC with residual disease after neoadjuvant therapy.
If successfully developed and approved, AstraZeneca and Daiichi Sankyo’s Dato-DXd will face direct competition from Gilead Sciences’ (GILD - Free Report) Trodelvy (sacituzumab govitecan-hziy).
Notably, in February 2023, the FDA expanded Trodelvy’s label to include the treatment of metastatic HR-positive, HER2-negative breast cancer in adults, who have previously been treated with endocrine-based therapy and additional systemic therapies.
GILD’s Trodelvy is a first-in-class, Trop-2 directed antibody-drug conjugate, which has the same mechanism of action as AZN’s Dato-DXd.
Trodelvy was previously approved under accelerated approval in the United States by the FDA for the treatment of metastatic TNBC, after the results from the confirmatory ASCENT study. It is also currently approved in the EU for the treatment of adult patients with metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer.
Gilead’s Trodelvy enjoys accelerated approval in the United States for the treatment of certain patients with second-line metastatic bladder cancer.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 28.2%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 55.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
AstraZeneca's (AZN) Dato-DXd Meets Goal in Breast Cancer Study
AstraZeneca Plc (AZN - Free Report) and its Japanese counterpart, Daiichi Sankyo, announced positive results from the late-stage study evaluating datopotamab deruxtecan (Dato-DXd) in the treatment of patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. The enrolled population for this study includes previously treated patients with endocrine-based therapy and at least one systemic therapy.
Per the data readout from the TROPION-Breast01 phase III study, treatment with Dato-DXd in the enrolled patient population led to a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival compared with the investigator’s choice of chemotherapy.
AstraZeneca also reported observing an improvement trend for the co-primary endpoint of overall survival (OS) upon treatment with Dato-DXd against chemotherapy. However, at the time of the interim analysis, the OS data were not mature and the study will continue to assess the same.
The safety profile of the drug was found to be consistent with previous studies in breast cancer. No new safety signals were identified.
Dato-DXd is a TROP2-directed DXd antibody-drug conjugate, which is currently being jointly developed by AstraZeneca and Daiichi Sankyo.
Shares of AstraZeneca climbed 1.2% on Friday in response to the encouraging news. Year to date, AZN stock failed to deliver any returns against the industry’s 5.7% rise.
Image Source: Zacks Investment Research
HR-positive, HER2-low or negative breast cancer is a common subtype, which is observed in approximately 65% of diagnosed breast cancer cases. Currently, the standard-of-care first-line treatment for breast cancer patients is endocrine therapy. However, per AstraZeneca, most patients with advanced breast cancer become resilient to treatment, representing a significant unmet medical need.
Notably, AstraZeneca and Daiichi Sankyo are also currently evaluating Dato-DXd in two additional phase III studies in breast cancer. The TROPION-Breast02 study is evaluating the efficacy of Dato-DXd in comparison to chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), who are ineligible for anti-PDL1 therapy.
On the other hand, the TROPION-Breast03 study is evaluating Dato-DXd both as a monotherapy and in combination with Imfinzi (durvalumab) against the investigator’s choice of therapy in patients with stage I-III TNBC with residual disease after neoadjuvant therapy.
If successfully developed and approved, AstraZeneca and Daiichi Sankyo’s Dato-DXd will face direct competition from Gilead Sciences’ (GILD - Free Report) Trodelvy (sacituzumab govitecan-hziy).
Notably, in February 2023, the FDA expanded Trodelvy’s label to include the treatment of metastatic HR-positive, HER2-negative breast cancer in adults, who have previously been treated with endocrine-based therapy and additional systemic therapies.
GILD’s Trodelvy is a first-in-class, Trop-2 directed antibody-drug conjugate, which has the same mechanism of action as AZN’s Dato-DXd.
Trodelvy was previously approved under accelerated approval in the United States by the FDA for the treatment of metastatic TNBC, after the results from the confirmatory ASCENT study. It is also currently approved in the EU for the treatment of adult patients with metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer.
Gilead’s Trodelvy enjoys accelerated approval in the United States for the treatment of certain patients with second-line metastatic bladder cancer.
Zacks Rank and Stocks to Consider
AstraZeneca currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 28.2%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 55.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.