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·PÁ¤pªL «e½úªº¤À¨É, ¯÷½Ķ¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò, ÁÂÁ¡C

Less Frequent Treatment Schedule Feasible for Patients With PV

¸û¤ÖªºªvÀø¶g´Á¦¸¼Æ¹ïPV¯f±w¬O¥i¦æ¤è®×

2017.11.08

Giving ropeginterferon alfa-2b to patients with polycythemia vera (PV) every four weeks instead of every two weeks yielded similar efficacy and was more convenient for patients during a small European study.

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Investigators from Austria, Germany and the Czech Republic conducted the PEGINVERA phase 1/2, prospective, open-label, multicenter study to investigate the safety and efficacy of ropeginterferon alfa-2b (AOP Orphan) in the long-term treatment of patients with confirmed PV.

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The PEGINVERA study includes data from PV patients treated with ropeginterferon alfa-2b for up to six years (median, four years). Patients were included whether or not they had received previous hydroxyurea therapy. The investigators evaluated patients older than 18 years of age, giving those responding well to every-two-week administration of ropeginterferon alfa-2b the option to switch to an every-four-week regimen, with a reduction in the monthly dose from approximately 300 to 165 mcg. All 29 patients switched to the less-frequent regimen, and no patients discontinued treatment.

PEGINVERA¬ã¨s¥]§t¥ÎP1101ªvÀøªø¹F¤»¦~ªº¼Æ¾Ú(ªvÀø¤¤¦ì¼Æ¥­§¡¬°4¦~)¡C¥]§t¥ý«e¬O§_¥Î¹LHUªvÀøªº¯f±w¡C¬ã¨sªÌµû¦ô¤F¶W¹L18·³ªº¯f±w¡A±N¨C¨â©P¤@°wªvÀø¦¨®Ä¨}¦nªº¯f±wÂà´«¦Ü¨C¥|©P¤@°wªº¾¯¶q, ¨C¤ëªº¾¯¶q¤]±q300 mcg­°¦Ü165 mcg¡CÁ`¼Æ29¦W¯f±w§¡¦b¤Á´«¦ÜªvÀøÀW²v­°§Cªº¾¯¶q«á, ¥þ¼Æ«ùÄòªvÀøµL°h¥X¡C

All the patients who switched to the every-four-week schedule were able to continue therapy for at least an additional two years, with high rates of hematologic and molecular responses and stable disease. Some have reached six years of treatment in this ongoing trial.

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The percentage of patients maintaining their best hematologic response before and six months after switching to the once-monthly regimen was consistent with the two dosing regimens (51.7%). Similarly, the percentage of patients maintaining their best molecular response before and six months after switching to the every-four-week regimen was not significantly different (62.1% vs. 58.6%).

¯f±w¦bÂà´«¦Ü¨C¤ë¤@°wªºÀøµ{¤»­Ó¤ë«á©M¨C¤ë¨â°wªºÆ[¹î¤ñ¸ûµo²{, ³Ì¨Î¦å²G¾Ç¤ÏÀ³¼Æ¾Ú¤@­P(51.7%)¡C¦P¼Ëªº, ¦b³Ì¨Îªº¤À¤l¤ÏÀ³¤W, ¯f±wÂà´«¦¨¨C¥|©P¤@°w¤»­Ó¤ë«á¼Æ¾Ú¤]µLÅãµÛ¤£¦P (62.1% vs. 58.6%)¡C

In addition, the investigators reported that the majority of PV patients being treated long term with ropeginterferon alfa-2b developed a sustained reduction of mutant JAK2 allele burden to below 10%, and no progression to myelofibrosis or leukemic transformation, which was maintained before and after switching to the less-frequent dosing regimen. They suggest that this demonstrates ¡§the unique disease modification by ropeginterferon alfa-2b treatment.¡¨

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The investigators concluded that ¡§long-term maintenance treatment of PV patients using monthly injections of ropeginterferon alfa-2b is feasible, efficacious and well tolerated,¡¨ suggesting that the treatment ¡§holds the promise of disease modification and delay of disease progression.¡¨

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¡XSarah Tilyou

Based on a study presented at the European Hematology Association 2017 Congress (abstract

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Clinical Oncology News

NOVEMBER 8, 2017

Less Frequent Treatment Schedule Feasible for Patients With PV

www.clinicaloncology.com/Hematologic-Malignancies/Article/11-17/Less-Frequent-Treatment-Schedule-Feasible-for-Patients-With-PV-/45233

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9th INTERNATIONAL PATIENT SYMPOSIUM ON MYELOPROLIFERATIVE NEOPLASMS

When: Wednesday, November 1, 2017

Where: Griffis Faculty Club, Weill Cornell Medical College

521 East 68th Street, New York, NY 10065

10:00 AM - Current Management of Polycythemia Vera

Richard T. Silver, MD, Weill Cornell Medical College, New York, NY

11:00 AM - Current Management of Essential Thrombocythemia

Carles Besses Raebel, MD, Hospital del Mar, Barcelona, Spain

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most likely unrelated to IFNa treatment - were reported.¡¨

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­Ó¤H»{¬°­«ÂI¬Owere reported...¬J¤w¦V¥DºÞ·í§½¥Ó³ø¡A·í§½µL·N¨£§Y¥i¡C

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Anyway,¥Î¦r»ºµü¤]¤£¬O¨º»ò­«­n¡A¬Ý¨ì¤½¥¬ªº¼Æ¾Ú¡AµØ¤Í­ÌÀ³¸Ó³£«Ü¶}¤ß¤~¬O¡C

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ÃĵØÃÄP1101,¤µ¤Ñ¦¨¥æ¶q1101±i,¯u¥©!
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¤ñ¸û­È±oÃöª`ªº¬O¥~¸ê©M§ë«H³£¨S¶R...

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·|­û¡G¤pªL10142678  µoªí®É¶¡:2017/11/3 ¤U¤È 08:06:10²Ä 3003 ½g¦^À³
Àù¯g³¡¤À¡AªÅ¤]ªÅªÅ¤j¸ÑÄÀ±o«Ü²M·¡¥B¤¤ªÖ¡C

¸É¥R¤£¨}¤ÏÀ³¤ñ²vªº³¡¤À¡A²Ä12­Ó¤ëP1101²Õ59.6%¡BHU²Õ75.6%¡A²Ä24­Ó¤ëP1101²Õ70.1%¡BHU²Õ77.2%¡A¬°¯f¤H¼Æ¤ñ²v¡C¥Ñ©ó¦UÃþ¤j¤pªº°Æ§@¥Î³£»Ý¬ö¿ý¡Aªø´ÁÁ{§É¸ÕÅç®É¶¡·U¤[¡A²Ö¿n´¿¦³¤£¨}¤ÏÀ³ªº¯f¤H¼Æ·|«ùÄò¼W¥[¡C¦]¦¹¶i¤@¨B¤ÀªRÁ`¤£¨}¨Æ¥ó¼Æ(event)¡B¤£¨}¨Æ¥óµ¥¯Å(grade)¡B¦]¤£¨}¨Æ¥ó­°§C¾¯¶q...µ¥¡A¤~¯àºî¦X¤ñ¸û¦w¥þ©Ê¡C

ºK­nµLªk§e²{³o»ò¦h¤º®e¡AÀ³·|¦b¦~·|®É¦A²³ø¡A°Ñ¦ÒProud-PV²Ä12­Ó¤ëªº¦w¥þ©Ê¼Æ¾Ú¦p¤U¡C

Any AE: P1101 81.9% vs HU 87.4%

Treatment-related AE: P1101 59.6% vs HU 75.6%

Grade 3 AE: P1101 16.5% (29 events in 21 patients) vs HU 20.5% (45 events in 26 patients)

Discontinuation at Mo 12: P1101 16.5% vs HU 12.6%

Dose reduction for AEs: P1101 25.2% vs HU 51.2%

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¡§¨ä¹ê¬O¤¤¤å­n½¦¨­^¤å¡A¨S½ºë·Ç¦Ó¤w¡C¡¨

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·d¤£¦n¡K

¤H®a¨ä¹ê¬O¤¤¤å­n½¦¨­^¤å¡A¨S½ºë·Ç¦Ó¤w¡C

«¢¡K¤£³£¬O¦Û¤v·Qªº¡K

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¡§whereas in the Ropeg cohort 3 malignancies (glioblastoma, seminoma, adrenal neoplasm) ¡V most likely unrelated to IFNa treatment - were reported.¡¨

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¤½¥qªºÂ½Ä¶¡§±©®Ú¾Ú³ø§iµ²ªGÅã¥Ü»P¤zÂZ¯ÀªvÀøµLÃö¡¨¬O¦³ÂI¨«ÄÁ¡A¹ê¦b¨S¦³¥²­n¡C

§Æ±æ³o¥u¬O¤@®É²¨©¿¡A¤£¬O¬G·Nªº¦æ¬°¡C

¦b­^½¤¤ªº¹Lµ{¡A°¾¦V¹ï¦Û¤v¦³§Qªº¤è¦V¡A¦b³o­Ó¤j®a³£À´ªº­^¤åªº®É¥N¡A¥u¯à»¡½Þ¶¤¤Í¡A·l®`¦Û¤vªº¤½«H¤O¡C

·sÃĬãµo³Ì­«­nªº¬O¤½«H¤O¡A¤p²Ó¸`²¨©¿¡AÅý¤H¯d¤UÃa¦L¶H¡A±N¨Ó¥i¯à¦Y¤jÁ«¡C

¥xÆW³o­ÓªÀ·|¡AªêµøÏàÏà¡A·QÄA­Ë¬O«Dªº¤H¤£¤Ö¡A©¹¦Û¤v¼âÁT¡A¤£ºÞ¦³·NµL·N¡A³£¬OÄø¡C

¤½¥q¦p¯à¶i¤@¨B¼á²M¦¹°ÝÃD¡A§ó¦n¡C

´N¥Ø«e¼Æ¾Ú¬Ý¨Ó¡AÀù¯g¤£¬O°ÝÃD¡C

´Nºâ¬OHU¡A¥é³æ¤W¤]¥u¦³»¡ªø´Á¨Ï¥Î¦³¦¸µo©Ê¦åÀù¤Î¥Ö½§Àù³ø§i¡C

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¡¨In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported.

Skin cancer has also been reported in patients receiving long-term hydroxyurea.

Advise protection from sun exposure and monitor for the development of secondary malignancies.¡¨

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±q¾ÇªÌµoªí½×¤åªº¥ß³õ¡A°£¤F´y­z«ÈÆ[ªº¼Æ¾Ú¥~¡A¤]­n»¡»¡¦Û¤vªº·Qªk¡C

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¤£¦Pªº§@ªÌ¹ï¬Û¦Pªº¼Æ¾Ú¡A·|¦³¤£¦Pªº½×ÂI¡Aťť´N¦n¡C

ªk³W³æ¦ì¹ï¼Æ¾Úªº¸ÑŪ¤]¦³¦Û¤vªº¤@®M¼Ð·Ç¡C

¦Ü©ó¡¨¤£¨}¤ÏÀ³²v¡¨(¤£¨}¨Æ¥ó²v¤ñ¸ûºë·Ç¡A¤£¨}¤ÏÀ³(adverse reaction)»P¤£¨}¨Æ¥ó(adverse event)µy¦³®t§O)¡A

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¥H²{¦b³o»òº}«Gªº¼Æ¾Ú§Q¦h,ªÑ»ù¦­¤wöt¨ì¤Ñ¤W¥h¤F!

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¤W¶g¥«³õ¬ã½Õ¾÷ºcCoherent Market Insights¥Xª©¤F¤@¥÷MPN¯e¯fÂåÃÄ¥«³õªº¤ÀªR³ø§i¡A³ø§iºK­n¤¤¦³´£¨ì¸û¨Î¤zÂZ¯À»s¾¯»P¼ç¦bÃĪ«¡A¤]´x´¤¨ì¤F«e°}¤lMPNRF±N¶}±Ò¤zÂZ¯À±M®×¬ã¨sªº°T®§¡C

www.coherentmarketinsights.com/ongoing-insight/myeloproliferative-neoplasms-treatment-market-930

MYELOPROLIFERATIVE NEOPLASMS TREATMENT MARKET BY DRUG (JAKFI) - GLOBAL INDUSTRY INSIGHTS, TRENDS, OUTLOOK, AND OPPORTUNITY ANALYSIS, 2017-2025

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Incyte Tops Q3 Earnings & Sales

https://finance.yahoo.com/news/incyte-tops-q3-earnings-sales-190507738.html

Incyte Corporation

Quarterly revenues were $381.5 million, up 41.6% year over year and beat the Zacks Consensus Estimate of $360.2 million. The top line was driven by higher sales of Jakafi in the United States and Iclusig in Europe as well as royalties from sales of Jakavi and Olumiant outside the United States.

Quarter in Detail

Jakafi sales grew 36%, year over year to $304 million driven by strong patient demand for both indications. Net product revenue of Iclusig amounted to $18 million, up from $13 million in the year-ago quarter. Product royalty revenues from Novartis AG NVS for the commercialization of Jakafi in ex-U.S. markets grew 36.7% to $41 million.

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More Than 30 Abstracts Highlighting Data from Incyte¡¦s Portfolio Accepted for Presentation at the 59th Annual ASH Meeting

Jakafi (ruxolitinib)

Saturday, December 9, 2017, 12:00-1:30 PM, Building B, Level 3, B312-B314, Oral Session 637, Myelodysplastic Syndromes¡XClinical Studies: Predicting Drug Response Using Novel Genomic Algorithms

Examining The Treatment Patterns And Blood Counts Among Patients With Polycythemia Vera Treated With Hydroxyurea In The United States: An Analysis From The REVEAL Study (Abstract #1633)

Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,

Poster Session I

Results From The 208-Week (4-year) Follow-Up Of RESPONSE Trial, A Phase 3 Study Comparing Ruxolitinib (Rux) With Best Available Therapy (BAT) For The Treatment Of Polycythemia Vera (PV) (Abstract #322)

Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210,

Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs

Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924)

Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210,

Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs

Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924)

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Background: Interferon-alpha (IFNa) based therapies have been successfully used in myeloproliferative neoplasms (MPN) for over thirty years. Ropeginterferon alfa-2b (Ropeg) is a novel mono-pegylated IFNa, which is administered once every 2 weeks, or monthly during long-term maintenance. Ropeg is developed in polycythemia vera (PV), and 12-month data from the randomized controlled phase III PROUD-PV study comparing Ropeg with hydroxyurea (HU) have been presented. Here we report 2 years treatment data obtained from the follow-up phase III CONTI-PV study.

Study design: 254 PV patients (WHO2008 criteria, naïve to cytoreduction or HU pretreated but not resistant) had been randomized to receive Ropeg or HU in the PROUD-PV study. After 12 months of treatment patients were rolled over to the CONTI-PV study: 95 of 106 (89.6%) patients completing the 12-month Ropeg arm, and 76 of 111 (68.5%) patients completing the 12-month HU arm continued in the second year. The latter cohort was also allowed to switch from the HU regimen to best available therapy (BAT) at the investigators discretion; a cross-over between groups was not allowed. Efficacy assessment consisted of complete hematological response (CHR) rate according to ELN criteria, and the CHR rate plus symptom improvement (PV-related symptoms and signs including clinically significant splenomegaly). Secondary endpoints included the effect of treatment on mutant JAK2 allele burden assessed as rate of molecular response (modified ELN criteria) as surrogate for disease modification.

Results: 88 (Ropeg) and 73 (HU/BAT) patients completed the 24-month efficacy analysis time point, the mean treatment duration for safety analysis was 2.7 years (both after initial randomization in the PROUD study). Median drug doses in the second year remained at the same level as during the first year: 450 µg Ropeg every 2 weeks and 1000 mg HU per day. In the HU/BAT arm over 98% of patients remained treated with HU, a switch to other BAT was rare. Discontinuation rates during the second year were comparable with 8.4% in the Ropeg and 6.6% in the HU/BAT arm, respectively.

At 24 months, treatment with Ropeg achieved a high CHR rate of 70.5%. This was significantly better than a CHR of 49.3% with HU/BAT, (p=0.0101, full-analysis-set). Importantly, in contrast to HU/BAT, response rates increased steadily in the Ropeg-treated group throughout the two-year treatment period. The composite endpoint CHR plus symptom improvement also favored Ropeg with 49.5% vs. 36.6% for HU/BAT (p=0.1183) at 24 months. The advantage of Ropeg was most pronounced in the effect on mutant JAK2 allele burden: at 24 months 69.6% of patients in the Ropeg arm but only 28.6% in the HU/BAT arm had achieved partial molecular response (p=0.0046).

Regarding safety, a comparable number of patients (70.1% for Ropeg, 77.2% for HU) experienced treatment-related adverse events. Anemia, thrombocytopenia and leukopenia occurred more frequently with HU, whereas GGT increase was observed only with Ropeg in some patients. Events of special interest for the class of IFNa (in particular thyroid disorders and depression) were below 5% in the Ropeg arm. Disease- or treatment-related secondary malignancies occurred only in the HU cohort, including 2 cases of acute leukemia, 1 melanoma and 2 basaliomas, whereas in the Ropeg cohort 3 malignancies (glioblastoma, seminoma, adrenal neoplasm) - most likely unrelated to IFNa treatment - were reported.

Conclusions: These data confirm a) the high and durable hematologic response and symptom improvement achieved with Ropeg, b) the excellent safety and tolerability profile of Ropeg, and c) the disease modification capability of Ropeg suggested by its ability to significantly reduce the mutant JAK2 allelic burden. Ropeginterferon alfa-2b will provide a valuable and safe new long-term treatment option for PV patients.

Disclosures: Gisslinger: AOP Orphan Pharmaceutic

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* Paul :

§A­ÌPegasysªº¹L´Á¤é¬°¦ó? ±q§Ú6¤ë¶}©l¥hÃħ½¶RªºPegasys¦³®Ä´Á­­³£¦b2019¦~3¤ë, ³oÅý§Ú¾á¤ß¬O§_ Genetech ¶}©l­pµe¦bªñ¦~´î²£©Î¬O°±²£, ¬O§_¦]¬°2019¦~ Ropeginterferon (P1101)¦b2019¦~­n¤W¥«, ÁÙ¬O³o¥u¬O§Ú¦h¼{¤F, ÁÂÁ¡C

* Ann: §Úªº¦³®Ä´Á­­¦b2019/09, ©Ò¥H¥Ø«e¬Ý°_¨Ó, §Ú¬Oı±o¨S°ÝÃD

* Courtney: §Úªº¦³®Ä´Á­­¤]¬O 2019/09

* Jill: §Úªº¤]¬O2019/09

* Angie: 2018/07

* Debra: ³oºØ¾á¤ß¦ü¥G¸g±`¥X²{, ¦ý³Ìªñ±o¨ì¤½¥q«OÃÒªñ9-12­Ó¤ë¥H¨Ó, ¤½¥q¥Ø«e¤´¨S¦³´î²£­pµe¡C

* Jill: §Ú¤W¦¸¦³¥´¹q¸Üµ¹¤½¥q, ¥L­Ì»¡¨S¦³¥ô¦ó´î°±²£­pµe, ¦Ó§Ú¦³¸ò¥L­Ì´£¨ì±µ¤U¨Ó¦³­Ó·sÃÄ·|¨ú¥N§A­Ì, ¥L­Ì¸ò§Ú»¡ Pegasys ¦b¦å²G¯e¯f(MPN)¥H¥~ªº»â°ì¤´¦³³\¦h¯e¯f»Ý­n¨Ï¥Î¡C

* Barbara: §Úªº¤]¬O2019/09

* Win: ªñ¤T­Ó¤ë®³¨ìªºPegasys ¦³®Ä´Á­­³£¬O2019/09, ¦ý§Ú¦í¼Ú¬w, ¤ñ¸û±µªñ¨ú±oP1101

* Melissa : §Úªº¤]¬O 2019/06, ù¤ó¥Í²£

* Paul: ¨º¬Ý¨ÓÃħ½®³®w¦s«~µ¹§Ú, §Ú¨ì¤W©P¥h®³ªº³£ÁÙ¬O2019/03

* Susana: ¦³½ìªº°ÝÃD, §Ú³Ì·sªº¦³®Ä¤é´Á¤]¬O¦b2019/10¤ë, 90mcg¥Ñù¤ó¥Í²£ªºª`®g¾¹¡C

* Cori: ¨â©P«e®³¨ìªº¨ì´Á¤é¬O2019¦~3¤ë, ¥ÑBriovaÁʶR¡C

* Lourdes : §Ú¤W­Ó¤ë®³¨ìªº¨ì´Á¤é¬O2019/09, ¥Ñ Acreddo Pharmacy¨ú±o¡C

* Bonnie: ©Ò¥H¥Ø«e§A­Ì»{¬°Pegasys ¦b2019¦~¤£¦A´£¨Ñ?

* Jill: ¹w¦ô¬O2019/2020¦~

* Elena: 2019/09

* Veronica: 2018/09

* Renate: §Úªº¬O2020/05, ¶Ç»DRocheªºPegasys±N·|¦b2023¦~³Q²^¨O, ©¡®É©Ò¦³¬ÛÃö°ê®a±N´£¨Ñ·s¤@¥Nªº¤zÂZ¯À, ¼w°ê¹w´Á2018¦~¥i¥H®³¨ìP1101¡C

* Barbara: Paul, ©êºp§Ú¿ù¤F, §Úªº¨ì´Á¤é¬O2018/10¤ë, ¥Ø«e§Ú¨C­Ó¤ë²£«~¨ì´Á¤é³£¦b¦¬¨ì²£«~«á¤@¦~¡C

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Dr. Jean-Jacques Kiladjian explained the difference between HU and Interferon:

youtu.be/UyKhws7pMFI

Proud-PV was the first randomized trial comparing interferon [ropeginterferon] to hydroxyurea in patients with PV as a first line therapy. We had the opportunity to study the hematogenic progenitors before and after 1 year of treatment in both the ropeginterferon and hydroxyurea arms. We picked up [sampled] the bone marrow cells before and after starting the one year treatment, then grew colonies in vitro [in the lab] and looked at which colonies had the Jak2 mutation or not.

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What we could see in this trial was that patients receiving ropeginterferon had a very important decrease in the proportion of colonies with the [Jak2] mutation after 12 months of treatment. This proportion was reduced by more than 60% and in comparison patients who received hydroxyurea in this trial reduced only by only 10-20%. So we could confirm in vivo [in real life] the two drugs have a different impact although they reduce blood counts similarly, interferon could act on the bone marrow progenitors by reducing the malignant cells and promoting the restoration of normal hematopoiesis.

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So we hope this will on longer term translate into an operational cure on the patients taking interferon. Although hydroxyurea can allow the good control of counts if you stop the drug the malignant cells are still there and the disease can proliferate again.

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2017/10/21 ¤U¤È 04:29:14²Ä 2890 ½g¦^À³
New drug trial for Polycythemia Vera initiated by Roche

MPN News | October 18, 2017

http://www.mpnresearchfoundation.org/

Hoffman-La Roche has a new trial they have initiated for Polycythemia Vera, for those who are either resistant to or intolerant of Hydroxyurea. The drug - NP39761 or Idasanutlin - is being tested in a Phase 1, single arm trial. The drug is taken orally by patients, and disrupts certain cancer causing pathways relevant to the JAK2 mutation. Outcomes for this trial vary based on the patient criteria going in, such as spleen size, hematocrit level and other variables. More information about this tria, including expected outcomes, is available on ClinicalTrials.gov by clicking here. Genentech Roche also has an information page about this ttrial available here. 

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°Ñ·Óhttps://www.aasld.org/events-professional-development/liver-meeting/program-0/late-breaking-abstracts?utm_source=homepage&utm_medium=latebreakingsessions&utm_campaign=rotator

Poster Sessions

Monday, October 23, 8 am-5:30 pm

LB-29:Every-two-week ropeginterferon alfa-2b is safe with better efficacy in interferon naïve patients with chronic hepatitis B virus infection: A phase 2, open-label, randomized, active control, dose finding study

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Mesa Highlights Guideline Updates in Myeloproliferative Neoplasms

MesaÂå¥Í§ó·s°©Åè¼W¥Í©Ê¸~½F(MPN)ªvÀø«ü«n

Angelica Welch

Published Online: Tuesday, Oct 10, 2017

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Ruben Mesa, MD

The National Comprehensive Cancer Network (NCCN) guidelines for the management of polycythemia vera (PV) and essential thrombocythemia (ET) have been updated to create a more uniform system of management for healthcare providers to follow in clinical practice.

¬ü°ê°ê®aÀù¯g¸ê°Tºô(NCCN) §ó·sÃö©ó¯u©Ê¬õ¦å²y¯u¦h¯g(PV)©M­ìµo©Ê¦å¤pªO¼W¦h¯g¡]ET¡^ªººÞ²z«ü«n, ³o®M²Î¤@ªººÞ²z¨t²Î¯à¬°ÂåÀø«O°·´£¨ÑªÌ´£¨Ñ¤@­ÓÁ{§É¤W¨Ì´`ªº¨Ì¾Ú¡C

Specifically in the guidelines, the needs of patients who progress on these myeloproliferative neoplasms (MPNs) are addressed. Although many patients with PV or ET can be treated with phlebotomy and aspirin, physicians must be aware that there is a population who will progress, says Ruben A. Mesa, MD.

Ruben A. Mesa³Õ¤h´£¨ì¡G³o®M«ü«n¸Ñ¨M¤F¹ï°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^´c¤Æ¯f±wªº»Ý¨D¡CÁöµM³\¦h±w¦³PV©ÎETªº¯f±w¥i¥H¨Ï¥ÎÀR¯ßª`®g©Mªü¥q¤ÇªL¶i¦æªvÀø¡A¦ýÂå¥Í¥²¶·¤F¸Ñ¦³¤@³¡¤Àªº¤H·|´c¤Æ¡C

¡§It is a big advance for these patients to finally have both the standardization, as well as the establishment of a standard of care with guidelines for therapy in the United States,¡¨ says Mesa. ¡§I would say that their management in the past has sometimes been more heterogeneous than would be ideal.¡¨

Mesa»¡¡G¡§§Ú­Ì¦b¬ü°ê«Ø¥ß¤F¤@­ÓªvÀø¼Ð·Çªº«ü«n¡AÅý³o¸s¯f±w²×©ó¯à°÷¥Î¼Ð·Ç¤Æªº¤è¦¡ªvÀø¡A³o¬O¤@¤j¶i¨B¡C ¡§§Ú»{¬°, ³o¸s¯f±w¹L¥h¦bªvÀø¤WªººÞ²z¦³®É¤ñ§Ú­Ì²z·Q»{ª¾ªº¤è¦¡§ó¬°½ÆÂø¡C¡¨

Additionally, the updated guidelines clarify the role of ruxolitinib (Jakafi), a JAK2 inhibitor used in the second-line setting for patients with PV.

¦¹¥~¡A³o¶µ«ü«n§ó·s³¡¤À§óÄÄ©ú¤Fruxolitinib (JAKAFi)ªº§@¥Î¡A¥¦¬O¤@ºØ¥Î©óPV¯f±w¤G½u¥ÎÃĪºJAK2§í¨î¾¯¡C

In an interview with OncLive during the NCCN 12th Annual Congress on Hematologic Malignancies, Mesa, director, UT Health San Antonio Cancer Center, shed light on these recent updates in PV and ET, and discussed the proper therapeutic management of these diseases.

¦bNCCN²Ä¤Q¤G©¡¦å²G´c©Ê¸~½F¦~·|´Á¶¡, OncLive±Ä³X¤F¸t¦wªF¥§¶øÀù¯g¤¤¤ß°õ¦æªøMesa, ¥LÄÄ­z¤FPV©METªñ´ÁªºªvÀø§ó·s±¡§Î, ¨Ã¹ï©ó³o¨Ç¯e¯fªº¾A·íªvÀø¤è¦¡¶i¦æ¤F°Q½×¡C

OncLive: What are the important updates in PV and ET?

OncLive¡GPV & ET ¦³¬Æ»ò­«­nªº§ó·s¡H

Mesa: These are the inaugural guidelines for the management of PV and ET coming out of the NCCN this summer. I am very excited, as the MPN panel chair, to be able to bring these to providers in the United States and elsewhere who are managing these patients. We are trying to bring some uniformity¡Xto set some standards in terms of care.

MesaÂå¥Í¡G³o¬O¤µ¦~®L¤Ñ¬ü°ê°ê®aÀù¯g¸ê°Tºô(NCCN)¥Xª©ªºPV©METªººÞ²z«ü«n¡C§@¬°°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^¥D®u¡A§Ú«Ü°ª¿³¯à°÷¦¨¬°¬ü°ê©M¨ä¥L¦a°Ï¥¿¦bºÞ²z³o¨Ç¯f±w©Ò´£¨Ñ¸ê°Tªº¤H¡C§Ú­Ì¥¿¦b§V¤O¨î©w¤@¨Ç¼Ð·ÇÅýªvÀø¤W¯à°µ¨ì²Î¤@©Ê¡C

Diseases such as PV and ET are unique in many ways. They are malignancies, but they are very chronic malignancies. Patients have a very long survival, and some patients may even have near-normal survival. All of that said, the diseases can progress and can really inflict morbidity on patients afflicted through risk of thrombosis, risk of hemorrhage, and risk of progression.

¹³PV©MET¬O«Ü¿W¯Sªº¯e¯f, ¥¦­Ì¬O¤@ºØ´c©Ê¸~½F, ÄÝ©ó«D±`ºC©Êªº´c©Ê¸~½F¡C¯f±w¯à«ùÄò¦s¬¡«Ü¤[, ¬Y¨Ç¯f±w¬Æ¦Ü±µªñ¥¿±`¥Í¦s¡CºØºØ¸ñ¶HÅã¥Ü, ³oÃþ¯e¯f·|´c¤Æ¨Ã¥B³z¹L¦å®ê¡B¥X¦å©Î¬O´c¤Æ±aµ¹¯f¤H¹ê»Ú¯gª¬¡C

Fundamentally, the guidelines try to first establish risks for a given patient such as thrombosis and bleeding¡Xthe morbidities that are suffering from. Additionally, they should be mindful of risk of progression. In both sets of diseases, our primary goals are the avoidance of thrombosis and bleeding in a risk-based fashion. Irrespective of risk, individuals likely start on baby aspirin. For individuals with PV, we try to control the hematocrit through phlebotomy.

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The quest to prevent cancer: Ko-Chung Lin, Founder & MD of PharmaEssentia

Àù¯g¹w¨¾ªº°l¨D¡GÃĵØÂåÃÄ PharmaEssentia ³Ð¿ì¤H­ÝÂå¾Ç¾ÇªÌªL°êÄÁ

Dr Ko-Chung Lin heads a cohort of scientists at PharmaEssentia that has made a major

breakthrough in the prevention of cancer.

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Elite executives are often asked, ¡¥What¡¦s the most rewarding aspect of your job?¡¦ It¡¦s a simple question, but due to the diverse nature of industries, it¡¦s not totally unheard of to be met with dead-air. Of course, that wasn¡¦t the case with Dr Ko-Chung Lin. How could it be, when the corporation he co-founded is on the verge of saving many, many lives?

³Ç¥XªººÞ²zªÌ³Ì±`³Q°Ý¨ìªº¬O¡G§Aªº¤u§@³Ì¦³»ù­Èªº³¡¤À¬°¦ó? ³o¬O­Ó«Ü²³æªº°ÝÃD, ¦ý¦]¬°¦U¦æ¦U·~ªº»â°ì¤£¦P, ¾É­P¦³®É·|¹J¨ì®ðª^«Ü»øªº®É­Ô¡C·íµM, ³o¥ó¨Æ¨Ã¤£·|µo¥Í¦bªL°êÄÁ³Õ¤h¨­¤W, ¦]¬°¥L³Ð¿ìªº¤½¥q¥¿»Ý­n¬@±Ï³\¦h¡B³\¦hªº¥Í©R¡C

PharmaEssentia was established in 2003 by Ko-Chung and a group of Taiwanese-American executives and scientists, aiming to develop effective, safe and cost-effective pharmaceutical products for the treatment of human diseases. Fourteen years and countless clinical tests later, and in cooperation with Austrian multinational pharmaceutical company AOP Orphan, the team is using a game-changing drug candidate called Ropeginterferon alfa-2b (P1101) to prevent cancer.

ÃĵØÂåÃÄ©ó 2003 ¦~¥ÑªL°êÄÁ©M¤@¸s¥xÆW-¬ü°êªººÞ²zªÌ©M¬ì¾Ç®a©Ò¦¨¥ß, ¦¨¥ß©v¦®¦b©ó¬ãµo¥X¦³®Ä¡B¦w¥þ©M¨ã¦³¦¨¥»®Ä¯qªºÃĪ«¥HªvÀø¤HÃþ¯e¯f¡C¦b 14 ¦~¶¡»P¶ø¦a§Qªº¸ó°ê»sÃĤ½¥q AOP Orphan ¦X§@¶i¦æµL¼ÆªºÁ{§É¸ÕÅç«á¡A³o­Ó¹Î¶¤¬ãµo¥X¥O¤H¦Õ¥Ø¤@·sªº·sÃĺ٧@ Ropeginterferon alfa-2b (P1101)¥Î¨Ó¹w¨¾Àù¯g¡C

Ko-Chung Lin is living a scientist¡¦s dream

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The diseases PharmaEssentia are targeting with P1101 are rare blood cancers, such as Polycythemia Vera. And after years of intensive trials, only a final sign-off from the governing medical bodies in Europe and the US stands between patients and the drug.

ÃĵØÃÄ©Ò¬ãµoªº P1101 ¥D­n¥Î¨ÓªvÀø¨u¨£ªº¦åÀù¯e¯f¡A¦p¯u©Ê¬õ¦å²y¼W¦h¯g(PV)¡C¸g¹L¦h¦~ªº±K¶°ªºÁ{§ÉÁ{§É¡A²{¦b¥u»Ý­n¼Ú·ù¥H¤Î¬ü°ê³Ì²×ªºÃÄÃÒ³\¥i§Y¥iÅý¯f±w¥ÎÃÄ¡C

¡§We have conceptualised an idea, and now we¡¦re making it a reality through Ropeginterferon alfa-2b,¡¨ Ko-Chung smiles. ¡§We found out it works in the treatment of Polycythemia Vera, and now we¡¦re just waiting on the final approval to save patients¡¦ lives. I¡¦ve been a scientist for 40 years, and it¡¦s the dream of any scientist to be in this position. It¡¦s very rewarding.¡¨

ªL°êÄÁ¯ºµÛ»¡ §Ú­ÌÂÇ¥Ñ Ropeginterferon alfa-2b ±N­ì¥ýªº·§©À¨ãÅé¤Æ, §Ú­Ìµo²{ P1101 ¦b PV ªºªvÀø¤W«Ü¦³®Ä, ¦Ó§Ú­Ì²{¦b¦bµ¥«Ý³Ì«áªº§å­ã§Y¥i¥Î¨Ó¬@±Ï¯f±wªº©Ê©R¡C§Ú¾á¥ô¬ì¾Ç®a¤w 40 ¦~, ³o¬O¥ô¦ó¤@­Ó¬ì¾Ç®a¦b¦¹¹Ú´K¥H¨Dªº, ³o¤@¤Á¬O¦³·N¸qªº¡C

I¡¦ve been a scientist for 40 years, and it¡¦s the dream of any scientist to be in this position. It¡¦s very rewarding. Testing has revealed that P1101 delays disease progression, has limited side effects, and has the potential to deliver a curative response. Patients can also self-administer at home, and on a monthly rather than fortnightly basis ¡V a significant improvement in both convenience and comfort from current treatment options.

Á{§É¸ÕÅçÅã¥Ü¥X P1101 ¥i´î½w¯e¯f´c¤Æ¡B°Æ§@¥Î·¥§C¡A¥B¦³ªv¡ªº¥i¯à¡C¯f±w¥i¥H¦b®a¦Û¦æ¬I¥´, ©P´Á¬°¨C­Ó¤ë¤@°w¡A¦Ó«D¨C¨â¶g¤@°w, ©M²{¦³ªvÀø¤è®×¬Û¤ñ, ³o­ÓÅãµÛªº§ï¨}¤£¶ÈÅý¯f±w·P¨ì§ó«K§Q¥B§óµÎ¾A¡C

Most excitingly, PharmaEssentia¡¦s potential is limitless. It has received another US$125 million in funding after being listed last year, has set up subsidiaries in the US, Japan and China, has more than 150 employees, and carried out its own manufacturing at the Central Taiwan Science Park.

³Ì¥O¤H¿³¾Äªº¬O¡AÃĵØÂåÃÄ PharmaEssentia ªº¼ç¤OµL­­¡C¦Û¥h¦~±¾µP¤WÂd«á, ÃB¥~¶Ò¶°¤F 1.25 »õ¬ü¤¸ªº¸êª÷¡AÃĵئb¬ü°ê¡B¤é¥»©M¤¤°ê³]¦³¤l¤½¥q¡A¾Ö¦³¶W¹L 150 ¦W­û¤u¡A¨Ã¦b¥xÆW¤¤³¡¬ì§Þ¶é°Ï¾Ö¦³¦Û¤vªº»s³y¤u¼t¡C

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