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SGEN

Seattle Genetics

$65.03

-2.55 (-3.77%)

, ALPMY

Astellas Pharma

$0.00

(0.00%)

07:43
06/03/19
06/03
07:43
06/03/19
07:43

Seattle Genetics, Astellas announce data from cohort of EV-201 trial

Seattle Genetics (SGEN) and Astellas Pharma (ALPMY) announced that data from the first cohort of a pivotal phase 2 clinical trial known as EV-201 demonstrated that the investigational agent enfortumab vedotin rapidly shrank tumors in most patients, resulting in an objective response rate of 44 percent. Complete responses were observed in 12 percent of patients. The median duration of tumor response was 7.6 months. This cohort was open to patients with locally advanced or metastatic urothelial cancer who had received previous treatment with a platinum-containing chemotherapy and a PD-1/L1 checkpoint inhibitor. Responses were similar in the subgroups of patients analyzed, including those who had the worst prognosis, such as patients who had three or more previous lines of therapy, patients with liver metastases, and those who had not responded to a PD-1/L1 inhibitor. Treatment-related adverse events that occurred in 40 percent or more of patients were fatigue, alopecia, rash, decreased appetite, taste distortion, and peripheral neuropathy. Enfortumab vedotin is an investigational antibody-drug conjugate that targets Nectin-4, a protein that is highly expressed in urothelial cancers. Based on the results of the EV-201 trial, the companies plan to submit a Biologics License Application for enfortumab vedotin to the U.S. Food and Drug Administration this year. Based on preliminary results from the phase 1 EV-101 trial, the FDA granted enfortumab vedotin Breakthrough Therapy designation for people with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy. A global, randomized phase 3 confirmatory clinical trial is ongoing and is intended to support global registrations. Another trial is underway to evaluate enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab and/or platinum chemotherapy in newly diagnosed patients as well as patients who progressed from earlier-stage disease. In the first cohort of the EV-201 study, 125 patients were treated with enfortumab vedotin. The primary endpoint of confirmed objective response rate was 44 percent per blinded independent central review. The overall duration of response, a key secondary endpoint, was 7.6 months. Most responses occurred within the first cycle of treatment, and were observed across all pre-specified patient subgroups irrespective of lines of therapy, response to prior PD-1/L1 inhibitor, or presence of liver metastases: Three or more prior therapies: 41 percent ORR; Non-responders to PD-1/L1 inhibitors: 41 percent ORR; Liver metastases: 38 percent ORR; Median overall survival was 11.7 months, and the median progression-free survival was 5.8 months. The most common treatment-related adverse events occurring in more than 40 percent of patients were fatigue; alopecia; rash; decreased appetite; taste distortion; and peripheral neuropathy. Most peripheral neuropathy and rash were less than or equal to Grade 2 in severity. Hyperglycemia occurred in 11 percent of patients. The most common severe AEs were: neutropenia - experienced by 8 percent of patients; anemia in 7 percent of patients; and fatigue in 6 percent of patients. One death due to interstitial lung disease occurred outside the safety-reporting period and was confounded by prolonged high-dose steroid use and suspected pneumonia.

SGEN

Seattle Genetics

$65.03

-2.55 (-3.77%)

ALPMY

Astellas Pharma

$0.00

(0.00%)

  • 06

    Jun

SGEN Seattle Genetics
$65.03

-2.55 (-3.77%)

03/27/19
BREN
03/27/19
INITIATION
Target $95
BREN
Buy
Seattle Genetics initiated with a Buy at Berenberg
Berenberg analyst Shanshan Xu initiated Seattle Genetics with a Buy and $95 price target saying he sees further appreciation following strong performance over the past 12 months. Xu believes several assets are undervalued at current levels including tucatinib in Phase III development for breast cancer, and enfortumab in Phase III development for urothelial carcinoma. Further, the analyst believes the receipt of a Complete Response Letter for the Biologics License Application for lead product candidate IMMU-132 for breast cancer may be resolved following an inspection by the FDA in second half 2019.
03/28/19
PIPR
03/28/19
NO CHANGE
PIPR
Neutral
Seattle Genetics' ORR 'impressive' for third-line UBC, says Piper Jaffray
After Seattle Genetics (SGEN) reported topline results from the first cohort of patients in a phase 2 trial evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received two prior lines of treatment, Piper Jaffray analyst Joseph Catanzaro said the 44% objective response rate, or ORR, was "impressive" in this population of patients. While he thinks there may be room for upward revisions to his assumptions, he prefers to wait for the full data set before making any changes. Catanzaro keeps a Neutral rating on Seattle Genetics, citing his concerns about the growth of Adcetris.
04/10/19
STFL
04/10/19
INITIATION
Target $70
STFL
Hold
Seattle Genetics initiated with a Hold at Stifel
Stifel analyst Stephen Willey initiated Seattle Genetics with a Hold rating and a price target of $70, saying that while the company "commands a leadership position in the development of antibody-drug conjugate technology", the current ADCETRIS estimates as "much-too-optimistic" in suggesting trajectory to sales of over $1B. The analyst adds that although the "recently-announced phase data for enfortumab vedotin will initiate Seattle Genetics' transition to a multi-product commercial company", he sees the "presumption of clinical/commercial success to be appropriately risk-adjusted in the stock at these levels."
04/25/19
PIPR
04/25/19
NO CHANGE
Target $64
PIPR
Neutral
Seattle Genetics Q1 marks third quarter of 'sluggish growth', says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro is keeping his Neutral rating and $64 price target on Seattle Genetics after its Q1 results that saw Adcetris sales of $135M missing consensus of $141M. The analyst notes that this marks the 3rd consecutive quarter of "sluggish growth", also lowering his FY19 EPS outlook to ($1.05) from (94c) and FY20 outlook to (14c) from 12c. Catanzaro lowers his FY19 Adcetris sales forecast to $611M from $633M, adding that the company's Adcentris revenue outlook of $610M-$640M for this year may "prove difficult."
ALPMY Astellas Pharma
$0.00

(0.00%)

06/08/18
GSCO
06/08/18
DOWNGRADE
GSCO
Neutral
Astellas Pharma downgraded to Neutral from Buy at Goldman Sachs
06/08/18
GSCO
06/08/18
DOWNGRADE
GSCO
Neutral
Goldman downgrades Astellas to Neutral with Xtandi growth priced in
Goldman Sachs analyst Akinori Ueda downgraded Astellas Pharma (ALPMY) to Neutral from Buy. Renewed appreciation for Xtandi's growth potential as well as Astellas' "proactive stance" on shareholder returns are largely priced into the stock, Ueda tells investors in a research note. With Japan Healthcare, the analyst prefers Santen Pharmaceutical, Shionogi and Sawai Pharmaceutical.
09/13/18
DBAB
09/13/18
DOWNGRADE
DBAB
Hold
Astellas Pharma downgraded to Hold from Buy at Deutsche Bank
Deutsche Bank analyst Joseph Cairnes downgraded Astellas Pharma to Hold with an unchanged price target of JPY 2,020. The analyst sees a more balanced risk/reward at current valuation levels.
11/05/18
JPMS
11/05/18
DOWNGRADE
JPMS
Underweight
Astellas Pharma downgraded to Underweight from Neutral at JPMorgan
JPMorgan analyst Naomi Kumagai downgraded Astellas Pharma to Underweight and lowered her price target for the shares to 1,400 yen from 1,600 yen. The analyst sees "many causes for concern."

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