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www.smartpatients.com/trials/NCT03831776

Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

Condition chronic myeloid leukemia

Treatments bosutinib, ropeginterferon

Phase phase 2

Targets BCR-ABL, SRC

Sponsor St. Olavs Hospital

Collaborator Haukeland University Hospital

Start date March 2019

End date March 2023

Trial size 212 participants

Trial identifier NCT03831776, 2018-001044-54, BosuPeg TRIAL

Summary

To study the efficacy and safety of combination of Ro-Peg-interferon-£\2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)

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2019.11.03

...

Jarno Nurminen David Wallace , not really. For example in Finland Besremi is not approved (not covered by insurances or public healt system). Also Pegasys is not approved. Only Roferon was available, but since it is no longer manufactured, we currently have no interf¡K¡K¬d¬Ý§ó¦h

David Wallace¡A¨Æ¹ê¨Ã«D¦p¦¹¡C(6446)ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀBESREMi® ¦bªâÄõ¥¼³Q§å­ã¡]«OÀI¤£µ¹¥I¡^¡Aù¤ó¤zÂZ¯ÀPegasys¤]¥¼³Q§å­ã¡A [¶È´£¨Ñ¶Ç²Î¤zÂZ¯ÀRoferon¨Ï¥Î¡A¦ý¥Ñ©ó¸ÓÃĤ£¦A¥Í²£¡A¦]¦¹§Ú­Ì¥Ø«e¤£¦A´£¨Ñ¤zÂZ¯ÀªvÀø¡C]

...

Jarno Nurminen I have an appointment with the hematologist next Thursday and he¡¦ll probably tell me what happens next. I¡¦m afraid he¡¦ll just drop me to hydroxurea despite the fact that my platelets have now been around 380-400 for a long time with 3MU Roferon twice w¡K¡K¬d¬Ý§ó¦h

¤U¶g¥|§Ú­n©M¦å²G¾Ç®a¸I­±¡A¥L¥i¯à·|§i¶D§Ú±µ¤U¨Óªºª¬ªp¡C§Ú«Ü©È¥L·|¥s§Ú¥ÎHUªvÀø¡A¾¨ºÞ§Úªº¦å¤pªO¨Ï¥Î¶Ç²Î¤zÂZ¯ÀRoferon¨C¶g¥ÎÃĨ⦸¤w¸gºû«ù380-400«Üªø¤@¬q®É¶¡¡C§Ú·Q»sÃĤ½¥q¬Æ¦Ü¨S¦³¦Ò¶q¨ì¦b³o¥Ó½Ðªø®Ä«¬¤zÂZ¯À¡A¦]¬°¥«³õ¤Ó¤p¡A³o¨Ç°Ó¤H»Ý­n§Q¼í¡C

Ida Idic I¡¦m on Besremi since 05.08. ...I live in Austria.My diagnosis is PMF CALR 1

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Ida Idic I feel better with Ropeginterferion - Besremi but my blood platelets are still high.Besremi need time for effect.

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F. Hoffmann-La Roche Ltd§iª¾¡A¥¦¤w¨M©w¦b¥þ²y½d³ò¤º³v¨B²^¨O©Ò¦³±j«×ªºRoferon-A¹w¶ñ¥Rª`®g¾¹ªº¥Í²£©M¤À¾P¡A¨Ã¥Ñ©óÁ{§É«ü«nªºÅܧó¦ÓºM¾P¨äµù¥U¡C³oºØ±¡ªp»PÃÄ«~ªº¦w¥þ©Ê©Î½è¶qµLÃö¡CRoferon-A 300¸U°ê»Ú³æ¦ì¡]IU¡^¸Ñ¨M¤è®×ªº³Ì·s¥æ¥I­p¹º©ó2020¦~ªì¦b¹w¸Ëª`®g¾¹¤¤¶i¦æª`®g¡A¸Óª`®g¾¹¤w¦b©Ô²æºû¨Èµù¥U¡]µù¥U¸¹05-0211¡^¡C

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www.zva.gov.lv/lv/jaunumi-un-publikacijas/jaunumi/zales-roferon-partrauks-izplatit-un-registraciju-anules-2020-gada-sakuma

..............................................................................................................................................................................................

Types of interferon alpha

....

Roferon is a short-acting interferon alpha available on the PBS for patients with a MPN associated with a high platelet count. It is usually given 3-5 times per week. It is available as a single dose syringe containing the exact amount of drug (3,6 or 9 MIU) required for one injection.

Pegasys is a longer-acting formulation (pegylated-interferon) which is injected only once a week and sometimes less often. This may have the advantage of fewer side effects, but a clinical study directly comparing the side effects of the two types of interferon has not been performed.

...............................................................................................

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mpnasia.com/site/mypage.aspx?pid=169&lang=en&sid=1284

2020 MPN Asia Sat.11.April.W Hotel,Taipei

Program

The 5th Annual International Symposium on Myeloproliferative Neoplasms

15:00 ¡V 15:25

Impact of Interferon on Mutational Status in Polycythemia Vera

Dr. Robert Kralovics

15:25 ¡V 16:00

Compassionate Use of Ropeginterferon Alfa-2b to Treat MPN Patients in Taiwan

Dr. Chih-Cheng Chen

Dr. Hsin-An Hou

16:00 ¡V 16:30

Updates in the Management of Polycythemia Vera, Essential Thrombocythemia and Prefibrotic Myelofibrosis

Dr. Heinz Gisslinger

16:30 ¡V 17:00

Thromboembolic Risk Reduction and High Rate of Complete Molecular Response with Long-Term Use of Ropeginterferon Alfa-2b in Polycythemia Vera

Dr. Jean-Jacques Kiladjian

17:00 ¡V 17:30

Panel Discussion: Interferon Renaissance

TBC

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www.nice.org.uk/guidance/indevelopment/gid-ta10497

Ropeginterferon alfa-2b for treating polycythaemia vera without symptomatic splenomegaly ID1596

In development [GID-TA10497]Expected publication date: 11 November 2020

Ropeginterferon alfa-2b¥Î©óªvÀøµL¯gª¬µÊ¸~¤jªº¯u©Ê¬õ²Ó­M¼W¦h¯gID1596

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Suggested remit - To appraise the clinical and cost effectiveness of ropeginterferon alfa-2b within its marketing authorisation for treating polycythaemia vera without symptomatic splenomegaly

«ØijªºÂ¾Åv½d³ò-µû¦ôropeginterferon alfa-2b¦b¨ä¾P°â³\¥i½d³ò¤ºªvÀøµL¯gª¬©ÊµÊ¸~¤jªº¯u©Ê¬õ²Ó­M¼W¦h¯gªºÁ{§É©M¦¨¥»®Ä¯q

As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of ropeginterferon alfa-2b for treating polycythaemia vera without symptomatic splenomegaly. Please note that following on from advice received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late January 2020. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust evidence submission

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www.onclive.com/onclive-tv/dr-rampal-on-treatment-options-in-polycythemia-vera

Dr. Rampal on Treatment Options in Polycythemia Vera

Raajit K. Rampal, MD, PhD

Published: Tuesday, Jan 07, 2020

Raajit K. Rampal, MD, PhD, hematologic oncologist, Memorial Sloan Kettering Cancer Center, discusses treatment options in polycythemia vera.

Initially, a patient should be evaluated to determine if they require pharmacologic treatment, explains Rampal.

Upfront treatment for patients who require therapy includes hydroxyurea and interferon. Long-term data suggests both agents are active in this space, says Rampal. Additionally, there is emerging data that ropeginterferon alfa-2b is another active agent in the frontline setting.

Patients who fail treatment with hydroxyurea should be considered for second-line therapywith the JAK1/2 inhibitor ruxolitinib (Jakafi). In later-line settings, investigational therapies are currently being explored, concludes Rampal.

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Spivak on PV

¡§How I Treat Polycythemia Vera¡¨

Jerry Spivak (Johns Hopkins University School of Medicine) Blood First Edition Paper, prepublished online May 31, 2019; DOI 10.1182/blood.2018834044

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Isn¡¦t hydroxyurea the front line drug for PV?

.... Importantly, in a PV RTC, with long term follow up, 24 % of hydroxyurea-treated patients developed AML by 20 years .

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AOP¦b2019.12.9¦å²G¯fÂå¾Ç¦~·|¡]ASH¡^¡A¥H¤fÀY³ø§i§Î¦¡µ²ªG¤§»¡©ú:...¦bRopeginterferon alfa-2b²Õ¡A²Ä48­Ó¤ë¦³13¦W±wªÌªºJAK2V617Fµ¥¦ì°ò¦]­t¾á§C©ó1¢H¡A¦Ó³o13¦W±wªÌ¤¤¦³11¦W¹F¨ì§¹¥þ¦å²G¾Ç¤ÏÀ³¡F¥t¥~34¦W±wªÌ¦b48­Ó¤ë®É¡A¨äµ¥¦ì°ò¦]­t²ü<10¢H....

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Impressive data presented by @jjkiladjian showing superior efficacy of ropeginterferon versus control arm in PROUD-PV with long term follow up. Compelling molecular data. Incredibly low incidence of vascular events in both arms

ª½Ä±Kevin¬O¥xÆW¤H?«Ü²M·¡¬ü°ê¬Æ®É­Ô·|¤W¥«!

1.Nicholas White 02/01/2020 06:58

Interesting, I¡¦ll look into the Ropeginterferon. Disappointing to hear that the Jakafi

doesn¡¦t work. As an update on the gene therapy brainstorming, I¡¦m talking to a few experts on

feasibility. Someone pointed out that the reason CAR-T therapy is so expensive...

2.Kevin 02/01/2020 12:09

Docs not sure why Interferon works so well, but it can put a patient into molecular remission

where the Jak2 is undetectable. Patient should start early. Ropeginterferon should be

available in US in Oct 2020. Jakafi is not really new and usually does nothing to stop

progression.

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David Wallace:

Alright. And that leads me into my next question. So, with Pegasys we have seen good results, showing hematological and molecular remission. As a patient that¡¦s on Pegasys and doing well, is there a benefit to switch into Ropeg? Or would you just keep the patient on the same medication?

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Dr. Kiladjian:

That is an important practical question, because a lot of patients on interferon, they currently are on Pegasys. Obviously, for Europe, the drug is now approved. The Ropeg has been approved for PV. So it would be natural to switch to this drug, because of regulatory reasons. Otherwise, I don¡¦t know if the patient is well on Pegasys. Is there a benefit to switch? I think the only possibility probably would be to achieve better molecular response and stop treatment. So if the patient on Pegasys still has a high amount of JAK2 mutation, maybe it could be nice to try the

other one. And also, the mode of administration is also easier. We have Ropeg pens that you can do for self-injection and doing one injection per month instead of weekly is also maybe an advantage for the patient.

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David Wallace:

Yes. And I can see that as a patient who takes Pegasys infrequently. But at one point, I was taking it every week. And to be able to push to once a month is a big deal, I think, for patients. Well, I¡¦d like to thank you for talking with me again this year. And I look forward to your studies in the future. You¡¦re always one of the world experts I like to keep an eye.

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Kairos

dim. déc. 22, 2019 1:33 pm

Apparemment le Besremi est disponible en Allemagne et en Autriche au prix de 2880 euro la seringue de 250mcg. Etant donné l¡¦énorme différence de prix actuellement par rapport au traitement mensuel avec Pegasys, il semble naturel que les autorités trainent un peu les pieds pour le remboursement du Besremi :) C¡¦est même à se demander si on trouvera un jour du Besremi en France :?:

.....................................................................................

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....Kairos:

sam. nov. 02, 2019 8:01 pm

A ma connaissance le Besremi est disponible en Allemagne depuis le mois de septembre et devrait l¡¦être logiquement en France au premier trimestre 2020.

m.apotheke-adhoc.de/nachrichten ... fertigpen/

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2.Subject:

Active Substance: Ropeginterferon alfa-2b

Name: Besremi®

Therapeutic area: Polycythaemia vera

Pharmaceutical company: AOP Orphan Pharmaceuticals AG

Time table:

Start: 15.09.2019

Publication of assessment: 16.12.2019

End of public hearing: 06.01.2020

Final decision by G-BA: expected for the beginning of March 2020

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www.practiceupdate.com/content/ash-2019-interferon-alfa-treatment-offers-best-outcomes-in-polycythemia-vera/94020/45

ASH 2019: Interferon-Alfa Treatment Offers Best Outcomes in Polycythemia Vera

December 8, 2019......

.....¡§This is the first time that interferon has been shown to improve survival in patients with polycythemia vera, compared with phlebotomy only or [hydroxyurea], as well as significantly increasing the time to develop myelofibrosis,¡¨ said Dr. Silver.......

This study received funding from Celgene and Novartis.

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www.pvreporter.com/ropeginterferon-effective-treatment-for-polycythemia-vera/?fbclid=IwAR0Xoe9VwVRdAtb0btM_DNWlRd_7no5EmCuDxoAT-O2kjKOxyjrmfG1awsM

Ropeginterferon for PV, Answers to questions you want to know ¡V

www.youtube.com/watch?v=Hpp2JUXiW1s

ASH 2019 MPN Updates, Ruben Mesa, MD.

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Avatar:

jeu. oct. 31, 2019 6:00 pm

A ma connaissance, le BESREMI est disponible. Il n¡¦est pas encore disponible en officine en raison d¡¦une négociation en cours sur le prix avec la HAS. Je vous tiens informés.

Je suis le président de ALTE-ASSO.

n¡¦hésitez pas à me questionner par mail, par message privé ou par téléphone au 0981377212

Kairos:

sam. nov. 02, 2019 8:01 pm

A ma connaissance le Besremi est disponible en Allemagne depuis le mois de septembre et devrait l¡¦être logiquement en France au premier trimestre 2020.

m.apotheke-adhoc.de/nachrichten ... fertigpen/

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·|­û¡GROGER588910148151  µoªí®É¶¡:2019/12/16 ¤W¤È 07:58:14²Ä 7679 ½g¦^À³
January 2019

¤TÁpÀøªk:link.springer.com/article/10.1007/s00281-018-0700-2

...triple therapy¡¨ is proposed as a novel treatment modality to be tested in clinical trials combining IFN-alpha2, DNA-hypomethylator, and ruxolitinib.

..[The cornerstone treatment of MPNs in the future is foreseen to be IFN-alpha2]...³o¬q³Ì§l¤Þ¥Ø¥ú!

...it is intriguing to consider if ¡§triple therapy¡¨ (IFN-alpha2 + DNA-hypomethylator + ruxolitinib) may be even more efficacious.

IFN-alpha2(ÃĵØBesremi) + DNA-hypomethylator(ImagoªºLSD1)+ ruxolitinib(IncyteªºJakafi)???

µ²ªG´N¬O¦Y¨ì¤j»æªº¼µ¦º,¦Ó¦Y¨ì»æ¤pªº¾j¤£¦º½G¤Ú¤Ú.¥t¥~«OÀI¤½¥q¤£·|¼Ö¨£¤TÃÄÁpªvªº¤Ñ»ùÃĶO!

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Elina lun. janv. 28, 2019 1:35 pm

Je reviens vers vous pour vous demander si quelqu¡¦un à le nouvel interferon comme traitement ? mon hématologue voulant que j¡¦arrête le Jacavi en échange de ce nouvel interferon. je dois avouer que je suis inquiete.

merci

Elina

jana lun. janv. 28, 2019 2:00 pm

Bonjour Elina , pourquoi inquiete? Votre hématologue ne vous a pas expliqué son idée pour vouloir passer au Besremi?

Il semblerait que ce nouvel interferon ne sera diffusé qu ¡¦en pharmacie d¡¦ hopitaux si j ¡¦ai bien compris.

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