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RESPONSE Trial¨Ã¤£¬OJakafi vs. HUªº¤@½u¥ÎÃÄPK¡A¦Ó¬O°w¹ïHU¤£­@¨ü/§ÜÃĪº¯f¤H¡A¶i¦æjakafi vs. BATªº¤G½u¥ÎÃÄPK¡CIncyte¬O¥ý©ó2010¦~ºË·ÇJakafi¤G½u¥ÎÃĶi¦æRESPONSE Trial¡A«á¨Ó¤~©ó2012¦~¦P¨B¼W¥[Jakafi vs. HUªºRelief¸ÕÅç(«á¨Ó¨S¹F¨ì¸ÕÅç¥Ø¼Ð)¡C

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1. One observational prospective study ¡]§Ú·QµØ¤Í­Ì³£ª¾¹D¡^

- overall hematologic response rate was similar for the IFN group and the HU group (70.3% and 70.8%, respectively).

- A molecular response¡]decreased JAK2 V617F allele burden¡^¡GIFN group vs HU group ¡]54.7% vs 19.4%¡^

- IFN group demonstrated

decreased phlebotomy needs

greater improvement in systemic symptoms (vasomotor symptoms, distal

paresthesia, and erythromelalgia)

- In patients with a JAK2 mutation, better 5-year progression-free survival (PFS) in the IFN group (75.9% vs 47.6%).

2. Treatment with HU was associated with a greater risk of secondary malignancies¡X including acute myeloid leukemia, myelodysplastic syndrome, and skin cancers¡Xcompared with IFN (25% vs 8%); HUªº­PÀù­·ÀI¡A¤Ñ¤jªº¦n®ø®§ ; P

3. the European LeukemiaNet (ELN) to caution against using HU in young patients (< 40 years)and has led others to advocate for prioritizing IFN as the treatment of choice for effecting cytoreduction in polycythemia vera. ELN¥D±i¦~«C±Ú¸s¥ý¦Ò¼{IFNªvÀø

4. The Myeloproliferative Disorders Research Consortium phase III trial ¡]high-risk newly diagnosed PV or ET) °w¹ï°ª­·ÀI¡A·s¶EÂ_PV or ET¡A´Á¤¤¤ÀªR¡G

- Overall response rate was 69% in the HU group and 81% in the PEG group (P = .6).

- Reduction in palpable splenomegaly at 12 months was more common in the PEG group (71%, compared with 29% in the HU group), µÊ¸~¤jªº¤U­°IFN²Õ¸ûÀu

- phlebotomy independence was more common in the HU group (0% phlebotomy use, compared with 20% in the PEG group).

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5¡ASince the current evidence does not reveal the ideal frontline cytoreductive therapy for polycythemia vera or essential thrombocythemia, we endorse HU or IFN based on patient preference with regard to toxicity profile and ease of administration. We do recommend adherence to the ELN guidelines that advise caution with regard to HU use in younger patients (< 40 years). µ²½×¡GHU, IFN¦U¦³ÀuÂI¡A¯f¤H¦Û¤v¨M©w¡H¡H§O§Ñ¤FHU¦³­PÀù¥i¯à

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Incyte Corporation Announces Top-Line Results From RELIEF Trial Of Ruxolitinib In Patients With Polycythemia Vera

* Statistical significance not achieved for the primary endpoint of symptom control; positive trends in favor of ruxolitinib versus hydroxyurea observed

* RELIEF trial conducted in patients who were generally well-controlled on hydroxyurea but reporting continued disease-related symptoms, a different population than the pivotal Phase III RESPONSE trial

* RELIEF not included in, nor required for, polycythemia vera (PV) sNDA submission; data expected to be presented at an upcoming scientific meeting

* sNDA submitted to FDA for PV in June 2014 based on the pivotal Phase III RESPONSE trial demonstrating superior clinical benefit of ruxolitinib over best available therapy in patients resistant to, or intolerant of, hydroxyurea

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today announced top-line results from RELIEF, a randomized, double-blind clinical trial designed to compare symptom improvement in 110 patients with polycythemia vera (PV) treated with ruxolitinib versus patients treated with hydroxyurea (HU). While positive trends were observed in favor of ruxolitinib, the trial did not achieve statistical significance for the primary endpoint as measured by the proportion of patients with = 50% reduction in a defined cluster of symptoms that included tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 compared to baseline. Topline results showed a 43.4% symptom response rate in the ruxolitinib arm and a 29.6% symptom response rate in the hydroxyurea arm (p=0.139). Full data from the RELIEF trial are expected to be presented at an upcoming scientific meeting.

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MPNforum Magazine Summer, 2017

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Silver ¡V When to treat with Interferon¡Kmolecular study yields compelling data.

(¤zÂZ¯À¥ýÅX) Silver Âå¥Í- ¦b¦ó®É¥Î¤zÂZ¯À¶i¦æªvÀø¤W, ¨ä¤À¤l¤ÏÀ³¬ã¨sÅã¥Ü¥O¤Hª`¥Øªº¦¨ªG¡C

It was a small trial, 16 women and 14 men, but it will have a big impact. The result of the study,¡§The Effect of Initial Molecular Profile on Response to Recombinant Interferon-a Treatment in Early Myelofibrosis will be published in the upcoming American Cancer Society¡¦s journal, Cancer. Lead author is interferon pioneer Dr. Richard T. Silver with an international crew of co-investigators. (Dr. Hans Hasselbalch appended a detailed analysis of the report in the issue, Dr. Nick Cross is one of the co-authors.)

³o¬O¤@¶µ¤p«¬¸ÕÅç, ¥]§t 14 ¦ì¨k©Ê»P 16 ¦ì¤k©Ê, ¦ýµ²ªG«o¦³Åå¤Hªº¼vÅT¡C¹ï©ó°©ÅèÅÖºû¤Æ(MF)ªì´Á¹B¥Î­«²Õ¤zÂZ¯ÀªvÀø©Ò²£¥Í¤À¤l«¬ºAªº¼vÅT±N·|¦b±µ¤U¨Óªº¬ü°êÀù¯g¨ó·|´Á¥Z¤¤µoªí¡C¥D­n§@ªÌ¬O¤zÂZ¯Àªº¥ýÅX Silver Âå¥Í¥H¤Î¥Lªº°ê»ÚÁp¦X¬ã¨s¹Î¶¤ (Hans Hasselbalch Âå¥Í¦b³o­ÓijÃD¤Wªþ¤W¤F¸Ô²Óªº³ø§i¤ÀªR, Nick Cross Âå¥Í¤]¬O¦@¦P§@ªÌ¤§¤@¡C)

Data from the study adds another strong molecular-based argument in favor of early use of interferon in treating MPN patients. ¡§The use of low-dose rIFNa in ¡§early¡¨ PMF, post-ET MF,and post-PV MF¡Kresulted in bone marrow reversion, regression of splenomegaly, and disease stabilization with tolerable toxicity in 73% of patients.¡¨ The cohort ¡X median treatment duration 5.6 years ¡X reflected the early MPN population: median age, 58 years, 22 were classified as low risk, and 8 were classified as intermediate-1 risk. The takeaway message: Molecular profiling at the time of diagnosis may predict prognosis and treatment response.

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¨Ó·½¡GMPNforum Magazine (Summer, 2017)

Silver ¡V When to treat with Interferon¡Kmolecular study yields compelling data.

It was a small trial, 16 women and 14 men, but it will have a big impact. The result of the study, ¡§The Effect of Initial Molecular Profile on Response to Recombinant Interferon-a Treatment in Early Myelofibrosis will be published in the upcoming American Cancer Society¡¦s journal, Cancer. Lead author is interferon pioneer Dr. Richard T. Silver with an international crew of co-investigators. (Dr. Hans Hasselbalch appended a detailed analysis of the report in the issue, Dr. Nick Cross is one of the co-authors.)

Data from the study adds another strong molecular-based argument in favor of early use of interferon in treating MPN patients. ¡§The use of low-dose rIFNa in ¡§early¡¨ PMF, post-ET MF,and post-PV MF¡Kresulted in bone marrow reversion, regression of splenomegaly, and disease stabilization with tolerable toxicity in 73% of patients.¡¨ The cohort ¡X median treatment duration 5.6 years ¡X reflected the early MPN population: median age, 58 years, 22 were classified as low risk, and 8 were classified as intermediate-1 risk. The takeaway message: Molecular profiling at the time of diagnosis may predict prognosis and treatment response.

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AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid

AOP ©t¨àÃĤ½¥q©MÃĵØÂåÃĤ½§i¦b°¨¼w¨½ªº²Ä22©¡¼Ú¬w¦å²G¦~·|¤¤3½gP1101 ¦bPV¾AÀ³¯gªº³Ì·sÁ{§Éµ²ªG

- Long-term maintenance treatment of Polycythemia Vera (PV) patients with Ropeginterferon alfa-2b administered every 4 weeks is feasible, efficacious and well tolerated.

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- Home self-administration of individual doses with a pen is well accepted and expected to support adherence in the long-term treatment of PV-patients

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- Disease modifying capability of Ropeginterferon alfa-2b and delay of disease progression in PV-patients is supported by latest clinical and molecular data

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- Ropeginterferon alfa-2b is currently under EMA review for marketing authorization in the EU by AOP Orphan, PharmaEssentia intends to seek FDA approval for Ropeginterferon alfa-2b in the U.S.

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VIENNA and TAIPEI, Taiwan, June 25, 2017 /PRNewswire/ -- AOP Orphan Pharmaceuticals AG (AOP Orphan) and PharmaEssentia Corporation (Taipei Exchange: 6446) announced latest results from 3 clinical studies on Ropeginterferon alfa-2b for patients with Polycythemia Vera (PV) presented at EHA 2017.

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Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon expected to be the first interferon approved for PV worldwide. It is currently under EMA review for marketing authorization in the EU by AOP Orphan, PharmaEssentia intends to seek its approval by the FDA in the U.S.

Ropeginterferon alfa-2b¬O¤@­Ó³Ð·sªº¡Bªø®Äªº¡B³æ¤@»E¤A¤G¾Jªº²ãÓi»Ä(Proline)¤zÂZ¯À¡A¹w­p±N¦¨¬°¥þ²y²Ä¤@­Ó³Q®Ö­ã¥Î©óªvÀøPV¯f±w¤§¤zÂZ¯À¡A¥Ø«e¤w¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡AÃĵØÂåÃĤ]³Wµe±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Ö­ã¡A¥H¦æ¾P©ó¬ü°ê¡C

Abstract EHA-3520: An update from the PEGINVERA study (NCT: 2010-018768-18) on long-term maintenance treatment of up to 6 years (median of 4 years) with Ropeginterferon alfa-2b was provided. Patients were successfully switched from the once every 2 weeks to the more convenient once every 4 weeks¡¦ long-term maintenance dosing schedule after a median of approximately 2 years.

EHA-3520ºK­n¡GPEGINVERA Á{§É¸ÕÅç(NCT¡G2010-018768-18)¡A´£¨Ñ¥HRopeginterferon alfa-2bªø´Áºû«ùªvÀø³Ìªø¹F6¦~(¤¤¦ì¼Æ¬°4¦~)¤§³Ì·sµ²ªG¡C¯f±w¦¨¥\¦a©ó¥­§¡¬ù2¦~ªº®É¶¡¥Ñ¨â¶g¤@¾¯Âà´«¨ì§ó¤è«Kªº4¶g¤@¾¯ªø´Áºû«ù¥ÎÃĮɵ{¡C

All 29 patients could be maintained on this schedule for another 2 years, representing 100% treatment adherence. The high rates of hematological (over 80% of the patients achieved partial or complete hematologic response) and molecular responses (up to 80% of the patients achieved partial or complete molecular response) were maintained after the switch to the 4 weeks¡¦ schedule and remain stable (trial still ongoing).

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After 4 years on Ropeginterferon alfa-2b, the majority of patients showed a sustained reduction of the mutant JAK2V617F allelic burden to below 10%, demonstrating the disease modifying capability of Ropeginterferon alfa-2b treatment.

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AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid

www.prnewswire.com/news-releases/aop-orphan-and-pharmaessentia-announce-latest-clinical-results-for-ropeginterferon-alfa-2b-in-polycythemia-vera-from-3-abstracts-presented-at-the-22nd-congress-of-the-european-hematology-association-eha-in-madrid-300479279.html

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