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Study Design
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Dupilumab in Patients With Moderate-to-severe COPD ,924¤H, ¤T´ÁÁ{§É
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS)
Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 924 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation Actual Study Start Date ƒÊ : April 15, 2019 Estimated Primary Completion Date ƒÊ : January 2022 Estimated Study Completion Date ƒÊ : April 2022
clinicaltrials.gov/ct2/show/NCT03930732?term=Dupilumab&draw=2&rank=23 |
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COPD(¤£¬O®ð³Ý/ý³Ý)¥«³õ¨S¦³¯«ÃĤ]ÁÙ¨S¦³§ÜÅéÃĪ«Àò§å¤W¥«!(Y¦³§ÜÅéÃĪ«Àò§å½Ð¤£§[§ó¥¿) ¾Ú¦ôp¡A¸Ó¯f¼vÅT¥þ²y¬ù3.84»õ¤H¡A¹wp¨ì2020±N¦¨¬°²Ä¤T¤jP¦º¦]¯À¡Cªì¦¸¶EÂ_®É¡A¬ù1/3¬°ÄY«©Î«D±`ÄY«ªºCOPDÃþ«¬¡C¥t¥~¡A¬ù¦³30-40%ªº¤¤«×¦Ü««×COPD±wªÌ§Y«K±µ¨ü¤TÁp§l¤JÀøªk¡]ICS/LAMA/LABA¡^¯f±¡¤´¤£¨ü±±¨î¨ÃÄ~Äò´c¤Æ¡C
2016ªº¤å³¹ www.nature.com/articles/mi201556 ....IL-13 receptor (R) £\1 and are key pharmacological targets in fibrotic diseases. However, the roles of IL-13R£\1 in mediating lung injury/repair are unclear........ |
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Dupixent¤W¥«²Ä5¦~¬D¾Ô100»õ¬ü¤¸ªº¾P°â¤£¬O¹Ú
¨C©u¼W¥[1.7»õ¬ü¤¸ªº¥þ²y¾P°â. ¦ô¥¼¨Ó¾P°â (2019 Q1 3.7(2019,3¤ë¨Ó·Ç¤W¥«) 2019 Q2 5.6 2019 Q3 7.3 2019 Q4 9.0 ¦Xp 25.3(³æ¦ì:»õ¬ü¤¸)
2020 Q1~Q4= 10.7+12.4+14.1+15.8=53(»õ¬ü¤¸)
2021 Q1~Q4= 17.5+19.2+20.9+22.6=80(»õ¬ü¤¸)
2022 Q1~Q4= 24.3+26+27.7+29.4+41.1=106(»õ¬ü¤¸)
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--------------------------------- investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2019-financial-and-operating
TABLE 5
REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions)
Six Months Ended June 30,(2019,«e6¤ë¾P°â) --------------------------------- Net product sales recorded by Sanofi*:
Dupixent
$(¦Ê¸U¬ü¤¸)
757.7(¬ü°ê¾P°â)¦~¼W²v254%
173.3(¹Ò¥~¾P°â)¦~¼W²v408%
931.0(¥þ²y¾P°â) ¦~¼W²v273% -----------------------------
2018¦~(«e6¤ë¾P°â)
298.1(¬ü°ê¾P°â)
42.5(¹Ò¥~¾P°â)
340.6(¥þ²y¾P°â)
------------------------------------------------- Three Months Ended June 30,(4-6¤ë¾P°â)
Net product sales recorded by Sanofi*:
Dupixent
$
454.7(¬ü°ê¾P°â)
$
102.6(¹Ò¥~¾P°â)
$
557.3(¥þ²y¾P°â),
-------- 2018¦~4-6¤ë $
180.9(¬ü°ê¾P°â)
$
28.3(¹Ò¥~¾P°â)
$
209.2(¥þ²y¾P°â)
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Secondary Outcome Measures ƒÊ : 1.PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)] [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)
2.PK parameters: Estimate of volume of distribution at steady state (Vss) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)
3.PK parameters: Subcutaneous bioavailability (F) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via SC route only (16 timepoints)
4.PK parameters: Dose-normalized Cmax (Cmax/dose) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)
5.PK parameters: AUC (AUC(0-inf)/dose) [ Time Frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months ] To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints) -------------------------------------------------------
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Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema
investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2019-financial-and-operating
TABLE 5 REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) Six Months Ended June 30,(2019,«e6¤ë¾P°â) --------------------------------- Net product sales recorded by Sanofi*: Dupixent $(¦Ê¸U¬ü¤¸) 757.7(¬ü°ê¾P°â)¦~¼W²v254% 173.3(¹Ò¥~¾P°â)¦~¼W²v408%
931.0(¥þ²y¾P°â) ¦~¼W²v273% ----------------------------- 2018¦~(«e6¤ë¾P°â) 298.1(¬ü°ê¾P°â) 42.5(¹Ò¥~¾P°â)
340.6(¥þ²y¾P°â)
------------------------------------------------- Three Months Ended June 30,(4-6¤ë¾P°â)
Net product sales recorded by Sanofi*: Dupixent $ 454.7(¬ü°ê¾P°â)
$ 102.6(¹Ò¥~¾P°â) $ 557.3(¥þ²y¾P°â),
-------- 2018¦~4-6¤ë $ 180.9(¬ü°ê¾P°â) $ 28.3(¹Ò¥~¾P°â)
$ 209.2(¥þ²y¾P°â)
Development History and FDA Approval Process for Dupixent
Date
Article
Jun 26, 2019 Approval FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis Mar 11, 2019 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents Oct 19, 2018 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema
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1.¨Æ¹êµo¥Í¤é:108/07/31 2.¤½¥q¦WºÙ:¨È·à±dªÑ¥÷¦³¤½¥q 3.»P¤½¥qÃö«Y(½Ð¿é¤J¥»¤½¥q©Î¤l¤½¥q):¥»¤½¥q 4.¬Û¤¬«ùªÑ¤ñ¨Ò:¤£¾A¥Î 5.µo¥Í½t¥Ñ:¥»¤½¥q±N©ó2019¼Ú¬w¸~½FÂå¾Ç·|(ESMO)¦~·|¶i¦æ¤@½gvarlitinib¾À³øµoªí¡C¥»¦¸¦~·|±N©ó9¤ë27¤é¦Ü10¤ë1¤é¦b¦è¯Z¤ú¤Ú¶ë¶©¯ÇÁ|¦æ¡C ¥»¦¸®i¥Xªº¾À³ø±Nµoªí¦³Ãövarlitinib¤@´ÁÁ{§É¸ÕÅ窺·s¼Æ¾Ú¡A¦¹¶µ¸ÕÅç«Y±´°Qvarlitinib¦X¨Ömodified irinotecan»Pinfusional 5-fluorouracil (mFOLFIRI)¨Ï¥Î¤EÓ¶g´Á«á±Ä¨úVarlitinib³æ¤@Àøªk©ó±ß´Á¹êÅé½F¤§¦w¥þ©Ê»P¨ä³Ì¤j@¨ü¾¯¶q(MTD)¡C ºKn¸ê°T¥i©ó9¤ë23¤é¼Ú¬w¤¤³¡®L¥O®É¶¡00:05¥i©ó¦¹¬d¬Ý: www.esmo.org/ 6.¦]À³±¹¬I:µL 7.¨ä¥LÀ³±Ô©ú¨Æ¶µ: (1)·sÃĶ}µo®Éµ{ªø¡B§ë¤J¸g¶O°ª¥B¥¼«OÃÒ¤@©w¯à¦¨¥\¡A¦¹µ¥¥i¯à¨Ï§ë¸ê±Á{·ÀI¡A§ë¸ê¤HÀ³¼f·V§PÂ_ÂÔ·V§ë¸ê¡C (2)¸Ô²Ó¤º®e½Ð¸Ô¤½¥q©xºôµo¥¬¤§·s»D½Z¡C
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µoªí®É¶¡:2019/7/31 ¤W¤È 10:37:11
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B mPFS: ¹êÅç²Õ 3.1 Ó¤ë ¹ï·Ó²Õ 1.5Ó¤ë ¨â²Õ®t1.6Ó¤ë ·ÀI¤ñ (95% CI) 0.55 (0.41, 0.75)
C «ÈÆ[¤ÏÀ³²v: ¹êÅç²Õ 7.7% (9/117) ¹ï·Ó²Õ 0.8% (1/119)
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·à¤l¤G½uÁx¹DÀù¥þ²y¼Ï¯Ã¬OÅç¸Ñª¼¨Ì¾ÚÁ{§É¸ÕÅç¹êÅç³]p±ø¥ó¦p¤U ( ³Ì«á¤@¦ì¦¬®×«á3Ó¤ë ©Î 70% ¨ü¸Õ PD ) ORR : Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1
PFS :Progression-free survival (PFS) - Time Frame: The later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ]
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µoªí®É¶¡:2019/7/31 ¤W¤È 09:18:46
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µoªí®É¶¡:2019/7/31 ¤W¤È 12:16:47
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mPFS ¹êÅç²Õ 3.1 Ó¤ë «ÈÆ[¤ÏÀ³²v 0.8% ( 1/119 )
¹ï·Ó²Õ 1.5Ó¤ë ¨â²Õ®t1.6Ó¤ë ·ÀI¤ñ (95% CI) 0.55 (0.41, 0.75)
www.ktgh.com.tw/Public/tbDrug/201808160842057055.pdf
·à¤l¤G½uÁx¹DÀù¥þ²y¼Ï¯Ã¬OÅç¸Ñª¼¨Ì¾ÚÁ{§É¸ÕÅç¹êÅç³]p±ø¥ó¦p¤U ( ³Ì«á¤@¦ì¦¬®×«á3Ó¤ë ©Î 70% ¨ü¸Õ PD ) ORR : Time Frame: the later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1
PFS :Progression-free survival (PFS) - Time Frame: The later of 3 months after last subject in or when 70% of the subjects (84 subjects) have experienced a PFS event in Part 1 ]
Ó¤H±À¦ô¹êÅç²Õ ¤§ mPFS ¤ñ¹ï·Ó²Õ mPFS ¦n ¤@ ¿´N¦³¹LÃö¾÷·|
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µoªí®É¶¡:2019/7/30 ¤U¤È 11:22:59
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HER®a±ÚªºPFS¦±½u¦³¾÷·|¬Û¦ü©óFIGHT-202,(¦¬®×14Ó¤ë+8Ó¤ë=22¤ë) FGHER2 47 ¤H¡A22¤HPD,25¤H¨ü¡AMPFS 9.2¤ë¡C
·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2019/7/11 ¤W¤È 09:42:59²Ä 1115 ½g¦^À³ Inctye (FIGHT-202) 87¤H¤G´ÁÁ{§É
2016/OCT²Ä¤@¦ì¦¬®×ªº¨ü¸Õ¨ì2018/JULY ¤w¸g¾ú22Ó¤ë ³Ì«á¤@¦ì¦¬®×¨ü¸Õ¨ì 2018/JULY (data cut as of July 24, 2018)¤w¸g¾ú8Ó¤ë¡C
*************************** ¤@.Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
clinicaltrials.gov/ct2/show/NCT02924376
****Study Start Date �� : October 2016
¤G.Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma
investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib
******Key Findings from FIGHT-202 Updated, longer-term follow-up data from the interim analysis presentedtoday at ESMO (data cut as of July 24, 2018) ****** show that in patients withadvanced/metastatic or surgically unresectable iCCA with FGFR2translocations treated with pemigatinib who had at least eight months offollow up (Cohort A, n=47),
¡X¡X¡X¡X¡X¡X ***** Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations
Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer)
ESMO 2018: Incyte Posters ---October 22, 2018
investor.incyte.com/events-and-presentations/presentations?field_nir_tags_target_id=All&promote=All&field_nir_asset_type_target_id%5B26%5D=26&items_per_page=10&page=1 |
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µoªí®É¶¡:2019/7/29 ¤W¤È 08:42:18
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µoªí®É¶¡:2019/7/27 ¤U¤È 01:33:32
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To:¸¤H¤j Carl°õ¦æªø»¡ªº¦~©³¼Æ¾Ú¥XÄl~~~²ö«D³o´N¬O¥ý«e©Ò´£ªº¡§¦³¤H¥ýª¾¹D¡¨~~~~ |
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µoªí®É¶¡:2019/7/26 ¤U¤È 06:24:02
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Commenting on the appointment, Dr Carl Firth said: ¡§With the upcoming pivotal readout later this year for varlitinib and the continued advance of our other programs, Andrew¡¦s commercial experience will be invaluable in taking the company to the next stage. This decision to separate the roles of Chairman and CEO allows us to maintain the high standards of corporate governance we have set ourselves and I look forward to working closely with Andrew in the months and years ahead.¡¨
Media and IR contacts
Emma Thompson Spurwing Communications Tel: +65 6571 2021 Email: ASLAN@spurwingcomms.com
Robert Uhl Westwicke Partners Tel: +1 858 356 5932 Email: robert.uhl@westwicke.com
About ASLAN Pharmaceuticals |
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µoªí®É¶¡:2019/7/26 ¤U¤È 04:40:07
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¨È·à±d-KY ¥ô©R·~¬É¸ê²`¤§²{¥ô¸³¨Æ·|¦¨û ANDREW HOWDEN ¬°¸³¨Æªø
2019 ¦~ 7 ¤ë 26 ¤é,·s¥[©Y ¡V »EµJ©óÁ{§É¶¥¬q¸~½F¤Î§K¬Ì¾Ç¤§Á{§É¶¥¬q¥Íª«»sÃĤ½¥q¨È·à±d- KY(NASDAQ:ASLN, TPEx:6497)¤µ¤é«Å¥¬¿ï¥ô Andrew Howden ¬°¸³¨Æªø¡C¦Û¤½¥q 2010 ¦~³Ð¥ß¥H¨Ó¾á¥ô¸³¨Æªøº[
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µoªí®É¶¡:2019/7/24 ¤U¤È 05:09:37
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Log-Rank Test www.real-statistics.com/survival-analysis/kaplan-meier-procedure/log-rank-test/
incyte fight 202 PFS K-M¹Ï
1¥þ³¡(87 ¤H) vs. other (40¤H)
x^2 4.746000186 p 2.94%
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2.¥þ³¡(87 ¤H) vs. FGFER22 (47¤H) x^2 3.925298477 p 4.76%
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3. FGFER22 (47¤H) vs. other (40¤H) x^2 21.48105417 p 0.0004%
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µoªí®É¶¡:2019/7/23 ¤W¤È 11:33:24
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µoªí®É¶¡:2019/7/23 ¤W¤È 11:17:40
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µoªí®É¶¡:2019/7/23 ¤W¤È 09:45:50
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*************************** ¤@.Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
clinicaltrials.gov/ct2/show/NCT02924376
****Study Start Date ƒÊ : October 2016
¤G.Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma
investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-interim-data-phase-2-trial-pemigatinib
******Key Findings from FIGHT-202 Updated, longer-term follow-up data from the interim analysis presentedtoday at ESMO (data cut as of July 24, 2018) ****** show that in patients withadvanced/metastatic or surgically unresectable iCCA with FGFR2translocations treated with pemigatinib who had at least eight months offollow up (Cohort A, n=47),
¡X¡X¡X¡X¡X¡X ***** Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations
Median PFS was 9.2 months in cohort A (Figure 5) ¡V¡V Median PFS in cohorts B and C were 2.1 and 1.7 months, respectively ¡´¡´ Median OS was 15.8 months in cohort A ¡V¡V Median OS in cohorts B and C were 6.8 and 4.0 months, respectively Figure 5. Kaplan-Meier Estimates of PFS (Assessed by Independent Reviewer)
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TREETOPP: A phase 2/3 study of varlitinib plus capecitabine versus placebo plus capecitabine as second-line treatment in patients with advanced or metastatic biliary tract cancers (BTCs).
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Interim Results of fight-202, A Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients With Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) With/Without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations
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