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Phase 2 randomized trial comparing ropeginterferon versus phlebotomy in low-risk patients with polycythemia vera. Results of the pre-planned interim analysis:

Ropeginterferon was safe and more effective than phlebotomy for keeping hematocrit on target in patients with low-risk PV. These findings suggest ropeginterferon is a viable option for PV patients, but ¡§old-fashioned phlebotomy can also be quite efficient,¡¨ Dr. Gribben said

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New Drugs Advance MPN Treatment Options

Published on June 18, 2020

patientpower.info/myeloproliferative-neoplasms/treatments/new-drugs-advance-mpn-treatment-options#read-transcript-anchor

¥D«ù¤HAndrew Schorr »P¨â¦ì MPN±M®aªº³X½Í:

Dr. Naveen Pemmaraju (from the University of Texas MD Anderson Cancer Center¼w¦{¤j¾Ç¦w¼w´ËÀù¯g¤¤¤ß)- »P¥t¤@KOL ºÙRopeg¬°¡¦¡¦super interferon¡¦¡¦ Dr. Srdan Verstovsek¦P¾÷ºc!

Dr. Jeanne Palmer (from the Mayo Clinic Arizona, about the status of clinical trials and research±ö¶ø¶E©ÒÂå¾Ç¤¤¤ß- ¥@¬ÉµÛ¦WÂåÀø¾÷ºc¤§¤@)

°Ý1: Andrew Schorr:

Okay. Dr. Pemmaraju let me ask you about another area. Some people are on interferons. So there¡¦s a drug that¡¦s been in trials for a while, ropeg. Where does that stand in the research for that?

µª1: Dr. Pemmaraju:

¡K¡K.Ropegylated interferon, or ropeg, which has a trade name in Europe, Besremi, has been one of the most important developments for me and for our groups in MPN. Especially the chronic earlier phases such as polycythemia vera. Importantly and maybe new to some of our viewers, this drug is actually just recently approved in Europe in patients with polycythemia vera with a very specific indication.

Importantly three facts I would give you.

One, it¡¦s an improvement over Pegasys, or pegylated interferon formulations that we know here in the US because it¡¦s really once every two weeks injection, rather than once every one week. That¡¦s already huge.

Two, it has less side effects it appears than our traditional pegylated interferon.

And three, Jean-Jacques [Inaudible] and our European colleagues have presented now four-year follow-up data. That¡¦s called the CONTINUATION-PV, out of the PROUD-PV studies. And the results really look very encouraging now at four years plus follow up that people can stay on this drug for a long period of time. Less side effects than we expected. And possibly a signal for less MPN events such as thrombosis, like blood clots. Of course, longer follow up needed.

°Ý2: Andrew Schorr:

¡K¡K¡KSo, the title of this program is The Future of MPN Research, hopefully after COVID-19. Do you see a direction for those of us living with these conditions, myelofibrosis, polycythemia vera, ET - essential thrombocythemia, where things will get better, we¡¦ll have more options?

µª2: Dr. Palmer:

Absolutely. It¡¦s never good to have an MPN, but if you¡¦re going to have one, you¡¦re in a good time to have it. Because we do, you already talked about the ropeginterferon, which I¡¦m really hoping gets approval. Having had some personal experience with the clinical trial here, that it¡¦s tolerated so much better. But I think right now we¡¦re not only coming with ways to alleviate symptoms, which is what we see with the JAK inhibitors, but there¡¦s also a lot of studies looking at ways to try to modify the disease. To try to perhaps even benefit the biology of the disease, rather than just making people feel better. (±j½ÕRoepg¤£¬O¹³¦³¨Ç§K¬Ì§í¨î¾¯¶È¶ÈÅý¤@¨Ç¯gª¬·Pı¦n¤@¨Ç¦Ó¤w, ¦Ó¬O¹ï¯e¯f¥Íª«¾Ç¥»¨­ªº¦n³B¡K¡K)

°Ý3: Andrew Schorr:

¡K¡K¡K.. Naveen, I want to ask you about¡K especially for people with ET.

Recently we had on a program my new best friend Ruth Fein who for over 25 years went from ET to PV, to then MF. But anybody with ET doesn¡¦t want to progress, or PV doesn¡¦t want to progress. So what about arresting the progression. Is the research going on there?

µª3: Dr. Pemmaraju:

I think the two breakthroughs in ET will be what you said. Is there a way to actually modify the disease at the level of the molecule? At the level of the biology, as Dr. Palmer was mentioning. So that¡¦s where your interferon, and this ropegylated interferon I think will be one of the most interesting programs to study.

°Ý4: Andrew Schorr:

¡K¡K.And Naveen, what about interferon related to having a positive effect in this time of the virus (COVID)?

µª4: Dr. Pemmaraju: (·Pı³o­Ó¦^µª¤ñ¸û°ûÂà, ¦P®ÉªÖ©wRopeg ¤Î Jakafi¹ï¯f¬rªº¬ã¨s¡K..¦^µª±o«Ü¤p¤ß,¡K¤j®a¦Û¤vºCºC«~¨ý¥h¡K)

Yes, essentially the same answer as Dr. Palmer nicely said. Our MPN therapies are interesting. They both have this predisposition towards creating an immune deficiency, an immune syndrome set up, both interferon and JAK inhibitors. And yet, some of their principles appear to be able to quell the cytokine storm, this natural host response to the virus. Same answer. You would not start or stop these drugs based on COVID alone. But your point is a good one. When you look at the research trials, some of these really do include and incorporate MPN-based therapies that are co-opted for COVID. It¡¦ll be very exciting and important to see that

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¦p6446©xºô½Ķ, ¦U¦ì¥i¥H¦A¬Ý¬Ý¦å²G±Ð¤÷¨º½g¦bEHAªº¥D­n¤º®e - «Ü¦³»ù­È! ¦Ó¦³½ìªº¬O Dr. Babui ¦bYoutube (Should ropeginterferon become SoC for all patients with low-risk PV? 2020¦~6¤ë16¤é) video at 2¡¦45¡¦¡¦ ¤¤´£¨ì:

ƒÜ#1 ¤p©ó60·³ªÌPV±wªÌ, ·í«e¼Ú¬wªº¥Õ¦å¯fGuideline¤¤«Øij°ß¤@ªº¤è°w¬O¥ý±Ä¥Î (©ñ¦å+ªü´µ¤ÇªL)

ƒÜ#2 ¦~ÄÖ¤j©ó60·³ªÌ, «h«e´ÁªvÀø¤è¦¡¬°HU/or interferon; ¦Ó·í¯f±w¹ï³o¨âªÌ²£¥Í¤£­@¨ü©Ê®É, Ruxolitinib§Y³Q¨Ï¥Î! ]

ªL°õ¦æªø¦b¤W¶g6/18¤¸´Iªk»¡·|®Éµyµy­z¤ÎÆg´­ Dr. Babui - ¦]¬°¾Ú»¡, ·í¦~©ñ¦å+ªü´µ¤ÇªL ³o¼ËªºªvÀø«ØijDr. Babui¦ü¥G¬OÃöÁä¤Hª«! ¦ý¬O¦p¤µ¥LµL¨pªº±N¬ì¾Çµ²ªG,º¥º¥´Â¦V±À½·í¤µªºGuideline¥D±i (©ñ¦å+ªü´µ¤ÇªL only for < 60·³ PV¯gª¬), µL¨pªº¬°¤F¯f±w§K©ó¯f±¡´c¤Æµoªí¤F³o­ÓRopeginterferon´Á¤¤¥O¤HÅåÆAªº¬ã¨sµ²ªG, ´£¥X¦b¥»¦~«×EHAªº³o­Ó¼ÐÃD (Should ropeginterferon become SoC all patients with low-risk PV)

¦U¦ì¤j¤jÀ³¤wª`·N¨ì, Babui¥»½g¬ã¨s¹ïRopegªºªÖ©w»P»ù­È:

²{¶¥¬qªº¼Ú¬wGuideline ¹ïRuxolitinib¦³§Q, ¦ÓDr. BabuiªºEHAµoªí¤å³¹½×ÂI«h¬Û¹ï­­ÁY¤Fruxolitinibªº¨Ï¥ÎªÅ¶¡- ²¦³º­Y¬ORopeg¦¨¬°<60·³ªºPV¼Ð·ÇÀøªk, ¦Ó«D (²{¶¥¬q: ©ñ¦å+ªü´µ¤ÇªL) ¡V ¥i¥H±À½×, ·íPV¯f±w¶V¬O¯à³Q±±¨î½w©M¯f±¡¤§´c¤Æ, ³B¤è¨Ï¥ÎRuxolitinibªº¾÷·|´N¬Û¹ï¤ñ¸û¤Ö!

±©, ¦³¨Ç¦æ·~Âå¥Í, ¦³·NµL·NµLµøRopeginterferon¥i¥H´î»´¯f±w¯f±¡´c¤Æªºªñ¦~¬ã¨sµoªí, ©¿²¤¯f¤H¬è¨D´M§ä¯f±¡®Úªvªº³B¤è¦P²z¤ß, ¤´´N«÷©Rªº¬°Ruxolitinib«Å´­, »{¬°Babui¬ã¨s»Ý­n²Ä¤G¦~©Î§óªøªº¼Æ¾Ú¤~±o¥H½×ÃÒ¨ä¥D±i¡K.

¦ý¬O, ©Z¥Õ»¡, ¨Ì·Ó.¼Ú¬üªº§ë²¼µ²ªG, ¥i¥H·Pı¥X¨Ó¦b¥«³õ¸ê°T³z©ú±¡ªp¤U, RopegÀ³¸Ó¬O¥i¥H³Q´Á«Ýªº¡K¡K(¤U¤@½g¦³ÃöPatient Power / MPN ¦U¦ì¥i¥H¦A¬Ý¬Ý New drugs advance MPN Treatment options «ç»ò´£¨ìRopeg ¦bPV / ET¡K¡K..)

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

¸É¥RR¤j ¦bDr. JJ Kilidjian Twitter ¦^À³¿ï²¼ªº¤@¨Çµû½×¦p¤U, (¦³½Ö¹³Dr. JJ Kilidjian ªí¥Õªº¦p¦¹ª½±µ»PÅåÆARopeg? ¨ä¾lªº¬Ý¬Ý´N¦n !)

Kevin

@Kevin173096936¤ë17¤é

¦^Âе¹ @jjkiladjian @MPN_Hub ©M@FimMpn

Dr. Silver, Dr. Hasselbalch, and many other European docs have preached(«ÅÁ¿/·¥¤O«Å´­) for years about the benefits of interferon. I¡¦m not surprised by these results and INF without question should be considered 1st line treatment as early as possible. Watch and wait and HU are not the answer.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Ruben A. Mesa, MD

@mpdrc 6¤ë22¤é

Looks like the majority are open to starting therapy for low risk PV. I agree and await the full results of the trial! #mpnsm

Adam Mead

@AdamMead_Oxford 6¤ë17¤é ¦^Âе¹ @jjkiladjian/@MPN_Hub/ ©M@FimMpn

Predictable that cytoreduction improves blood counts in low risk PV and endpoints primarily based on blood counts. Symptom data promising but prelim. Such a trial needs long term follow up and hard end-points in my view e.g. thrombotic events, transformation, molecular response.

Serge Rosenbaum

@serge_rosenbaum

6¤ë17¤é ¦^Âе¹ @jjkiladjian/ @MPN_Hub/ ©M@FimMpn

Is there a study comparing the benefits of Besremi versus Jakavi ?

@serge_rosenbaum

6¤ë17¤é

I should say Interferon versus Ruxolitinib

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@jjkiladjian

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Thanks for your votes and surprised to see that half of participants are ready to use #interferon in patients with low risk #PolycythemiaVera. Early treatment with careful exclusion of contraindications and monitoring is possibly the path to operational cure #mpnsm

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1.J.J. Kiladjian (¼Ú¬w)

And what is your opinion?

Should ropeginterferon become the standard of care for patients with low-risk PV?

Yes 48.5%

No 10.6%

Not enough evidence 37.9%

Already the case for me 3%

66 ²¼ ¡P

¤W¤È12:57 ¡P 2020¦~6¤ë17¤é¡PTwitter Web App

2.Ruben A. Mesa, MD (¬ü°ê)

Will Prof Barbuis trial at #EHA25Virtual (Ropeg INF better than Phleb alone) for low risk PV

change your approach? #mpnsm

. Poll: Would you consider using interferon (ie Ropeg) for low risk PV to improve symptoms,

prevent thrombosis decr phlebs?

Yes 66.7%

No 33.3%

36 ²¼

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And what is your opinion?

Should ropeginterferon become the standard of care for patients with low-risk PV?

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

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A very good question, let¡¦s listen to the opinion of Prof Barbui...

MPN_Hub@MPN_Hub ¡P 6¤ë16¤é

CONGRESS | #EHA25Virtual | At this year¡¦s EHA Meeting, the @MPN_Hub asked Tiziano Barbui, L¡¦ospedale Papa Giovanni XXIII: Should ropeginterferon become SoC for all patients with low-risk PV? Watch the interview here ➡️ mpn-hub.com/medical-information/should-ropeginterferon-become-soc-for-all-patients-with-low-risk-pv

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

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Ruben A. Mesa, MD

6¤ë15¤é

Will Prof Barbuis trial at #EHA25Virtual (Ropeg INF better than Phleb alone) for low risk PV change your approach? #mpnsm

@UTHealthSAMDA

@MPN_Hub

@MPN_RF

. Poll: Would you consider using interferon (ie Ropeg) for low risk PV to improve symptoms, prevent thrombosis decr phlebs?

33 ²¼ ¡P ³Ñ¤U 3 ¤Ñ

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

Tiziano Barbui:µ¥Á{§É¸ÕÅç²Ä¤G¦~ªº­«­n¼Æ¾ÚJak2 Allele Burden«á¤~¯à¦³µª®×¡A©Î¦³¾÷·|§áÂàPVªº[¯e¯f¦ÛµM¥v]!

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Novel approaches for MPNs

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Ruben Mesa, MD, of UT Health San Antonio MD Anderson Cancer Center, San Antonio, TX, describes novel developments in the treatment of myloproliferative neoplasms (MPNs) including the development of IMG-7289 for essential thrombocythemia (ET) and myelofibrosis as well as studies evaluating ropeginterferon alfa-2b for both ET and polycythemia vera. This interview was recorded via an online conference call with The Video Journal of Hematological Oncology (VJHemOnc).

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library.ehaweb.org/eha/2020/eha25th/293574/robert.kralovics.ropeginterferon.alpha-2b.is.efficacious.and.reduces.variant.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dropeginterferon

ROPEGINTERFERON ALPHA-2B IS EFFICACIOUS AND REDUCES VARIANT TET2 ALLELE BURDEN IN PATIENTS WITH POLYCYTHAEMIA VERA AND TET2 MUTATION: GENETIC ANALYSIS OF PHASE III PROUD-PV/CONTINUATION-PV STUDIES

EHA Library. Kralovics R. 06/12/20; 293574; EP1085

Conclusion

Ropeginterferon alpha-2b induces high haematological and molecular responses in patients with PV regardless of TET2 mutational status. Ropeginterferon significantly reduces the mutational burden of both JAK and TET2, thus reducing the mutated HSC pool, underscoring the disease-modifying capability of this stem-cell targeting agent.

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