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SGEN

Seattle Genetics

$65.03

-2.55 (-3.77%)

08:07
06/03/19
06/03
08:07
06/03/19
08:07

Seattle Genetics announces additional analyses of ECHELON-1, ECHELON-2 trials

Seattle Genetics announced additional analyses of results from ECHELON-1 and ECHELON-2, the frontline phase 3 trials of ADCETRIS, at the 2019 American Society of Clinical Oncology Annual Meeting. The ECHELON-1 analysis highlights a three-year update of this phase 3 clinical trial evaluating ADCETRIS in combination with AVD compared to ABVD in stage III or IV frontline classical Hodgkin lymphoma patients, including analyses by cycle 2 PET status and in patients less than 60 years old. In addition, two poster presentations evaluate CD30 expression and response to ADCETRIS treatment in the ECHELON-2 phase 3 clinical trial in peripheral T-cell lymphomas and an analysis of five additional trials in T-cell and B-cell non-Hodgkin lymphomas. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-year Update of the ECHELON-1 Study: This poster presentation examines progression-free survival outcomes per investigator assessment in the intent-to-treat population of 1,334 patients at three-years by PET status and in patients less than 60 years old. As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by independent review facility. Modified PFS was defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy. Key findings from these analyses include: The three-year PFS for all patients in the ADCETRIS plus AVD arm was 83.1 percent compared to 76 percent in the ABVD arm, a difference of 7.1 percent. PFS benefit at three-years for ADCETRIS plus AVD was observed for all patients independent of PET2 status, including in patients who are less than 60 years old. PET2-negative result was 85.8 percent in the ADCETRIS plus AVD arm compared to 79.5 percent in the ABVD arm, a difference of 6.3 percent. PET2-positive result was 67.7 percent in the ADCETRIS plus AVD arm compared to 51.5 percent in the ABVD arm, a difference of 16.2 percent. Consistent improvement in PFS was observed among patients treated with ADCETRIS plus AVD compared with ABVD across the majority of pre-specified subgroups, including disease stage, age and prognostic score. As previously reported at the primary analysis, on the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent in the ABVD arm. The three-year analysis shows that among patients with peripheral neuropathy, 78 percent of in the ADCETRIS plus AVD arm and 83 percent in the ABVD arm reported complete resolution or improvement at last follow-up. Response to A+CHP by CD30 Expression in the ECHELON-2 Trial: As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per Blinded Independent Central Review. In addition, overall survival in the ADCETRIS plus CHP arm was statistically significant compared to CHOP. Complete remission rate and objective response rate for the ADCETRIS plus CHP arm were also significantly increased. CD30 expression is a hallmark of systemic anaplastic large cell lymphoma, but it is variably expressed among non-sALCL PTCL subtypes. As a lack of correlation between CD30 expression and response to ADCETRIS has been previously reported, an analysis was conducted to examine response to ADCETRIS plus CHP by CD30 expression in 57 patients with angioimmunoblastic T-cell lymphoma and PTCL-not otherwise specified in the ECHELON-2 study, the two histologies with variable expression. Key findings of this exploratory analysis include: Among AITL and PTCL-NOS patients, the ORR in patients treated with ADCETRIS plus CHP was independent of the level of CD30 expression. CRs and PRs were observed in patients with all levels of CD30 expression, including those with the lowest level of 10 percent. The duration of complete response was not associated with CD30 expression level for patients with AITL or PTCL-NOS. Response to Brentuximab Vedotin by CD30 Expression: Results from Five Trials in PTCL, CTCL, and B-cell Lymphomas: Exploratory analyses were conducted to examine the correlation between pretreatment CD30 expression level and ORR for patients with CD30 expression greater than or equal to 10 percent, less than 10 percent, or undetectable by immunohistochemistry. This analysis examined CD30 expression levels of 275 patients across five clinical studies in relapsed or refractory PTCL, cutaneous T-cell lymphoma, and B-cell NHL. All patients in this analysis were treated with ADCETRIS monotherapy. The key findings include: Responses were observed with ADCETRIS treatment in patients with all levels of CD30 expression, including in patients with no detectable CD30 expression by IHC. Response to ADCETRIS was not associated with CD30 expression level. The U.S. Food and Drug Administration approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial. The FDA approved ADCETRIS in combination with CHP for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including AITL and PTCL-NOS based on the results of the ECHELON-2 phase 3 trial, in November 2018.

  • 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."

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  • 14

    Nov

  • 21

    Nov

  • 09

    Dec

FIBK

First Interstate

$43.01

0.34 (0.80%)

17:53
10/23/19
10/23
17:53
10/23/19
17:53
Earnings
First Interstate reports Q3 EPS 76c, consensus 79c »

Reports Q3 revenue…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

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  • 24

    Oct

  • 06

    Nov

MYGN

Myriad Genetics

$31.58

-0.71 (-2.20%)

, GSK

GlaxoSmithKline

$43.25

0.74 (1.74%)

17:43
10/23/19
10/23
17:43
10/23/19
17:43
Hot Stocks
Myriad Genetics announces FDA approval of myChoice CDx test »

Myriad Genetics (MYGN)…

MYGN

Myriad Genetics

$31.58

-0.71 (-2.20%)

GSK

GlaxoSmithKline

$43.25

0.74 (1.74%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

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  • 07

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