MPNs

Naveen Pemmaraju, MD, discussed potential combination regimens with ruxolitinib (Jakafi) being explored to improve outcomes for patients with myelofibrosis at the 2019 SOHO Annual Meeting. 

In an interview with&nbsp;<em>Targeted Oncology</em>,&nbsp;Naveen Pemmaraju, MD, discussed the results from the phase I/II trial of single-agent tagraxofusp used to treat patients with R/R myelofibrosis and&nbsp;examined novel agents and combination regimens that are being studied to potentially treat this patient population.<br /> <br /> &nbsp;

Here&#39;s a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

Naveen Pemmaraju, MD, discusses the current understandings of how myelofibrosis presents in patients.

A dose-finding phase Ib study successfully evaluated a combined regimen of oral ruxolitinib and buparlisib in adult patients with intermediate- or high-risk primary or secondary myelofibrosis for safety and efficacy.&nbsp;

In an interview with <em>Targeted Oncology</em>, McCloskey discussed current treatment options for patients with myelofibrosis as well as further options in development in clinical trials. McCloskey recommended that community oncologists partner with specialists to improve the prognosis for these patients until new agents are approved, and for referrals to clinical trials for further research for this patient population.

In an interview with&nbsp;<em>Targeted Oncology</em>, Ruben Mesa, MD, discussed the results from the reanalysis of the JAKARTA-2 trial that led to the approval of fedratinib in patients with MF. He also highlighted the role of the FREEDOM study that is currently enrolling patients with MF for treatment with fedratinib.

The FDA has approved the treatment of fedratinib for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis, including post-polycythemia vera or post-essential thrombocythemia myelofibrosis.

Marina Kremyanskaya, MD, PhD, discusses unique findings from the phase II trial investigating the effect of CPI-0610, a bromodomain and extra-terminal protein inhibitor, as treatment for patients with myelofibrosis who previously progressed on ruxolitinib.

Srdan Verstovsek, MD, PhD, discussed the treatment decisions he makes when treating a patient with a myeloproliferative neoplasm.

In an interview with&nbsp;Targeted Oncology, Naveen Pemmaraju, MD, an associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discussed the safety of SL-401 as a treatment in patients with MF following relapse or intolerance to JAK inhibition, based on data from an ongoing phase I/II clinical trial. He highlighted other research that also appear promising for this subgroup of patients with a poor prognosis.

The MDM2 antagonist idasanutlin was found to be clinically active and well tolerated in patients with previously treated polycythemia vera. Additionally, on-target <em>TP53 </em>pathway activation was observed in treatment-refractory patients with PV who were treated with idasanutlin, according to the results of a phase I clinical trial.<br /> &nbsp;

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for&nbsp;bevacizumab across several indications.

Ruben Mesa, MD, discusses the results from a reanalysis of the phase II JAKARTA-2 study in patients with myelofibrosis (MF) who received a previous treatment of ruxolitinib (Jakafi) and failed treatment.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Marina Kremyanskaya, MD, PhD, discussed the results from the phase II trial investigating the effects of CPI-0610 with or without ruxolitinib in patients with MF. Overall, the drug was well tolerated and effective in patients who had previously progressed on ruxolitinib or received inadequate responses to treatment.

A new meta-analysis quantifying the risks and benefits of using hydroxyurea to treat polycythemia vera found that while the incidence of thrombosis and acute myeloid leukemia were stable over time, mortality and transformation to myelofibrosis varied depending on follow-up duration.

Polatuzumab vedotin in combination with&nbsp;bendamustine and rituximab has been granted an accelerated approval from the FDA for the&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.<br /> &nbsp;

The FDA has granted a fast track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.<br /> &nbsp;

Aziz Nazha, MD, discusses the different agents being explored for patients who have progressed on ruxolitinib, and why this is a significant unmet need. He also highlights the role of genetics in patients with MF and how a better understanding can help guide treatment decisions.

Robyn M. Scherber, MD, MPH, discusses her advice for treating patients with myelofibrosis that become refractory or resistant to ruxolitinib.

Rami S. Komrokji, MD, explains the diagnostic and molecular workup behind myeloproliferative neoplasm diagnoses and discusses treatment options based on the case scenario of a patient with myelofibrosis.

Raajit K. Rampal, MD, PhD,&nbsp;discusses a retrospective analysis of pre-transplant samples from patients with MF to determine the value of mutational profiling in predicting outcomes after transplant.

A new report published in<em> Leukemia Research</em> found that results from the lead-in cohort of an open-label phase lb/II trial of glasdegib in patients with primary or secondary myelofibrosis previously treated with at least 1 JAK inhibitor indicated acceptable safety and tolerability.