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healthunlocked.com/mpnvoice/posts/140104508/inf-trial-for-early-mf-impact-of-mutations

INF trial for early MF - impact of mutations

1.Not seen the full version before. Some interesting info albeit a couple of years old

onlinelibrary.wiley.com/doi...

I believe that Ropeg now approved for EU? Anyone know when it will become available?

2.BESREMi (Ropeginterferon) was granted marketing Authorization by the EU today the 21st February.

See aoporphan.at/news-medien/st...

I guess that AOP has now got to negotiate prices with the various national health services before it will become available. How long that will take is anyone¡¦s guess.

3.Another more recent update re Peg v HU and Ropeg v HU

onclive.com/publications/mi...

4.Thanks for posting -now that Besremi has got European approval, I think it use will then be determined at national level and by each Trust

5.My haematologist has told me it¡¦s unlikely that Ropeginterferon will initially be approved for general use by most NHS trusts as it is massively more expensive than Pegasys, regular interferon and other treatments such as HU.

Given that many trusts won¡¦t even approve Pegasys on cost grounds it sounds like Ropeginterferon could be an uphill struggle at first.

The situation might change in due course if Pegasys is discontinued by Roche due to declining sales in its original hepatitis field but my haem doesn¡¦t think that¡¦s likely to happen till the mid 2020¡¦s.

It¡¦s great that Ropeginterferon has been approved but we may be in for a long wait till those of us in the UK can access it on the NHS..!

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¥ý¤F¸Ñ¤@¤U³o¦ì³Õ¤h(Kambhampati) ©ÒÄݾ÷ºc Sarah Cannon Research Institute, HCA Midwest Health ¬°¦ó?

Sarah Cannon Research Institute¦¹¬ã¨s¾÷ºcªþÄÝ©ó¬ü°êÂå°|¤½¥q(HCA, Health Care Inc)

(Note: en.wikipedia.org/wiki/HCA_Healthcare)

¬ü°êÂå°|¤½¥qHCA ºX¤U¦b¥þ¬ü¦³178­ÓÂå°|, ¥Ø«e¦bNYSE¤W¥«¤§ªÑ»ù¬° $138 USD

¤À¨É¨â½g MD Suman Kambhampati¤å³¹...

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@ www.onclive.com/publications/milestones-in-medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/dr-kambhampati-on-ropeginterferon-alfa2b-in-myeloproliferative-neoplasms

@ youtu.be/sZODflQwYaI

Topic #: Ropeginterferon Alfa-2b in Myeloproliferative Neoplasms

Suman Kambhampati, MD, co-director of the Blood Cancer Center at Sarah Cannon Research Institute, HCA Midwest Health

Published: Thursday, Feb 28, 2019

Ropeginterferon alfa-2b is a pegylated form of interferon that is being investigated in MPNs. At the 2018 ASCO Annual Meeting, data were presented on the agent, although physicians are anticipating more mature data by the end of 2020, says Kambhampati. Based on the trial, interferon was found to be noninferior to hydroxyurea as a frontline therapy. Pending more data, this agent may bring a more tolerable and newer generation interferon to patients, he adds.

Currently, interferon can be used as frontline or second-line therapy in patients with MPNs, explains Kambhampati. In the first-line setting, interferon is comparable to hydroxyurea. In patients who are intolerant to hydroxyurea, interferon can also be used as an appropriate therapy. Interferon is a disease-modifying agent which shows efficacy in inducing molecular remissions across mutational burden.

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www.onclive.com/publications/Milestones-in-Medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/dr-kambhampati-discusses-role-of-interferon-in-mpns

Topic #: Role of Interferon in MPNs

Suman Kambhampati, MD

Published: Monday, Feb 25, 2019

Suman Kambhampati, MD, co-director of the Blood Cancer Center at Sarah Cannon Research Institute, HCA Midwest Health, discusses the role of interferon in the treatment of patients with myeloproliferative neoplasms (MPNs).

Interferon is a naturally occurring cytokine, Kambhampati says, and everyone has interferons in their system endogenously. As a treatment option for MPNs, interferon is supposed to regulate hematopoiesis. Dating back to the 1980s, the role of this drug has been studied vigorously by investigators in the United States and Europe. While newer drugs like hydroxyurea have shown efficacy and become part of routine practice in polycythemia vera (PV) and other MPNs subsets, investigators still believe that there is a use for interferon.

For example, in PV, patients typically develop symptomatic iron deficiency and thrombotic events. Interferon, which inhibits critical pathways, reduces the risk of these events. Kambhampati adds that interferon can act as a disease-modifying agent and reduce the tumor mutational burden associated with myelofibrosis and other disease subtypes of MPNs, leading to deep responses.

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Two more interesting papers are shared here....

www.onclive.com/onclive-tv/dr-verstovsek-on-toxicity-profile-of-ruxolitinib-in-mpns

Dr. Verstovsek on Toxicity Profile of Ruxolitinib in MPNs

Srdan Verstovsek, MD, PhD

Published: Thursday, Feb 21, 2019

Srdan Verstovsek, MD, PhD, director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms at The University of Texas MD Anderson Cancer Center, discusses the toxicity profile of ruxolitinib (Jakafi) in the treatment of patients with myeloproliferative neoplasms (MPNs).

¡¦¡¦One of the biggest challenges with ruxolitinib is the safety of the drug, Verstovsek says. In patients with myelofibrosis, exposure to the drug in clinical trials is 3 years; however, in clinical practice it may not be that long. Researchers have identified some adverse events (AEs) that are of concern, among these events is immunosuppression§K¬Ì§í¨î. As a result, viral infections can be an issue, particularly hepatic ¨xinfections, which are seen in 5% to 6% of patients. There are other forms of infection like fungal ¯uµßinfections that do not appear in clinical trial data, but Verstovsek notes that oncologists should still be cognizant of them.

In addition, there have been incidences of squamous cell carcinomaÅ쪬²Ó­MÀù, a nonmelanoma skin cancer«D¦â¯À½F¥Ö½§Àù, developing in these patients. These patients are treated with frontline hydroxyurea, which is well-known to cause these skin issues; second-line ruxolitinib can make it worse.

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www.onclive.com/publications/milestones-in-medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/pegylated-interferon-formulations-shake-up-mpn-treatment

Pegylated Interferon Formulations Shake Up MPN Treatment

Caroline Seymour

Published: Monday, Feb 25, 2019

Abdulraheem Yacoub, MD

Due to the lack of comparative data between interferon and standard therapies, interferon has historically been reserved as a second-line therapy for patients with myeloproliferative neoplasms (MPNs). However, pegylated formulations, such as peginterferon alfa-2a (Pegasys) and ropeginterferon alfa-2b (PEG-Intron), have demonstrated higher safety, efficacy, and tolerability profiles, explained Abdulraheem Yacoub, MD.

Interferon is one of the earlier therapies that we¡¦ve had for this indication. Over the past 50 years, we have been using interferon with variable success. There has been a lot of progress since [it was first introduced to the landscape].

Q: How do you decide between interferon and hydroxyurea?

¡¦¡¦There are advantages with both options. Hydroxyurea is readily available and very inexpensive. All doctors are very comfortable prescribing it and managing it. It¡¦s an active drug¡X70% of patients who receive hydroxyurea will not need any additional therapy. Interferon is also a very good first- or second-line treatment option for patients, but there are some challenges associated with it. Two challenges are the availability and the cost. Since the medication is not FDA-approved for this indication, acquiring it through insurance takes multiple attempts and may not always be approved. However, we have made a lot of progress recently; a lot of insurance providers are now approving interferon for patients.¡¦¡¦

Q: Where is future research with interferon headed?

We¡¦re always trying to achieve disease control in our patients with the least amount of side effects. [We hope clinical trials will guide us] in our choice of therapy. The most recent molecule, ropeginterferon alfa-2b is a candidate for future clinical trials. It has a significant half- life that allows for administration every 14 days or every month¡Xthat¡¦s a significant improvement in QoL and convenience for patients. This particular medication was studied in international clinical trials and was also found to be noninferior to hydroxyurea, and potentially superior as long-term therapy. This molecule is being investigated in an international clinical trial for first- or second-line therapy for patients with ET and PV.

There has also been data with the use of interferon for patients with newly diagnosed myelofibrosis who don¡¦t have advanced disease features or advanced scarring of the bone marrow.

These data show that interferon might result in a slowing or modifying of the disease behavior. In addition, interferon combinations are now emerging to try to boost its activity and result in a deeper, faster, or safer response.

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