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Seagen's (SGEN) Combo Drug Meets Goals in Bladder Cancer Study
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Seagen Inc. and partner, Astellas Pharma, announced positive top-line results from its late-stage study of the combination therapy of Padcev (enfortumab vedotin-ejfv) with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for the treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
The enrolled population for this study included previously untreated la/mUC patients who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.
Per the data readout, the phase III EV-302 study met its co-primary endpoints of overall survival (OS) and progression-free survival compared with chemotherapy. An independent data monitoring body reaffirmed that the OS result exceeded efficacy expectations at interim analysis. Seagen will present detailed results from the study at an upcoming medical conference.
The safety profile of the Padcev/Keytruda combination was consistent with previously reported safety data from prior studies of the combination therapy in cisplatin-ineligible patients with la/mUC.
The stock of the company climbed 3.5% on Friday in response to the encouraging update from its bladder cancer study. Year to date, shares of Seagen have shot up 66.3% against the industry’s 16.1% fall.
Image Source: Zacks Investment Research
Enrolled patients in the phase III EV-302 study were randomized to receive either the combination therapy of Padcev and Keytruda, or chemotherapy.
We would like to remind the investors, that in April 2023, the FDA granted accelerated approval to the Padcev/Keytruda combo for the treatment of adult patients with first and second-line metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The accelerated nod was based on encouraging results from Seagen’s early-to-mid-stage EV-103 study, which was announced in September 2022.
The EV-302 study is expected to serve as the confirmatory study for the continued approval of the Padcev/Keytruda combo in the United States in the above indication. The EV-302 study results are also intended to support global submissions for regulatory approvals of the combination therapy.
SGEN’s Padcev was initially approved by the FDA in December 2019, on an accelerated basis for the treatment of patients with advanced/metastatic bladder cancer, who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
The company is simultaneously evaluating the Padcev/Keytruda combo in other forms of bladder cancer as part of its extensive program, evaluating this combination in multiple stages of bladder cancer.
The phase Ib/II EV-103 study is evaluating Padcev as a monotherapy or in combination with Keytruda and/or chemotherapy in first- or second-line settings in patients with la/mUC and muscle-invasive bladder cancer (MIBC).
Two phase III studies, EV-304 and EV-303, are also currently ongoing to evaluate the Padcev/Keytruda combo in MIBC. Currently, Seagen does not have any evidence for the proven safety and efficacy of the Padcev/Keytruda combo in second-line urothelial cancer and MIBC.
Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of MRK’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Merck’s Keytruda is continuously growing and expanding into new indications and markets globally.
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%.
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Seagen's (SGEN) Combo Drug Meets Goals in Bladder Cancer Study
Seagen Inc. and partner, Astellas Pharma, announced positive top-line results from its late-stage study of the combination therapy of Padcev (enfortumab vedotin-ejfv) with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for the treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
The enrolled population for this study included previously untreated la/mUC patients who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.
Per the data readout, the phase III EV-302 study met its co-primary endpoints of overall survival (OS) and progression-free survival compared with chemotherapy. An independent data monitoring body reaffirmed that the OS result exceeded efficacy expectations at interim analysis. Seagen will present detailed results from the study at an upcoming medical conference.
The safety profile of the Padcev/Keytruda combination was consistent with previously reported safety data from prior studies of the combination therapy in cisplatin-ineligible patients with la/mUC.
The stock of the company climbed 3.5% on Friday in response to the encouraging update from its bladder cancer study. Year to date, shares of Seagen have shot up 66.3% against the industry’s 16.1% fall.
Image Source: Zacks Investment Research
Enrolled patients in the phase III EV-302 study were randomized to receive either the combination therapy of Padcev and Keytruda, or chemotherapy.
We would like to remind the investors, that in April 2023, the FDA granted accelerated approval to the Padcev/Keytruda combo for the treatment of adult patients with first and second-line metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The accelerated nod was based on encouraging results from Seagen’s early-to-mid-stage EV-103 study, which was announced in September 2022.
The EV-302 study is expected to serve as the confirmatory study for the continued approval of the Padcev/Keytruda combo in the United States in the above indication. The EV-302 study results are also intended to support global submissions for regulatory approvals of the combination therapy.
SGEN’s Padcev was initially approved by the FDA in December 2019, on an accelerated basis for the treatment of patients with advanced/metastatic bladder cancer, who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
The company is simultaneously evaluating the Padcev/Keytruda combo in other forms of bladder cancer as part of its extensive program, evaluating this combination in multiple stages of bladder cancer.
The phase Ib/II EV-103 study is evaluating Padcev as a monotherapy or in combination with Keytruda and/or chemotherapy in first- or second-line settings in patients with la/mUC and muscle-invasive bladder cancer (MIBC).
Two phase III studies, EV-304 and EV-303, are also currently ongoing to evaluate the Padcev/Keytruda combo in MIBC. Currently, Seagen does not have any evidence for the proven safety and efficacy of the Padcev/Keytruda combo in second-line urothelial cancer and MIBC.
Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of MRK’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Merck’s Keytruda is continuously growing and expanding into new indications and markets globally.
Zacks Rank and Stocks to Consider
Seagen currently has a Zacks Rank #4 (Sell).
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%.