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Sunday, December 2, 2018

Some state lawmakers aim to ease child vaccine rules, but legal barriers persist


Despite an uptick in anti-vaccine legislation proposed by state lawmakers in recent years, pro-vaccine bills were more likely to be enacted into law, according to a new study by researchers at Drexel University. The results were published this week in the American Journal of Public Health.
“It is reassuring to know that the legislative process is working in favor of public health. It is concerning that there are so many anti-vaccination bills introduced, but our study shows that those bills are rarely signed into law,” said study principal investigator Neal D. Goldstein, PhD, an assistant research professor in Drexel’s Dornsife School of Public Health.
The use of nonmedical exemptions from vaccination requirements increased nationwide by 19 percent from 2009 to 2013, which has led to a disease resurgence in communities across the United States. However, both pro- and anti-vaccination policies vary widely state-by-state. The Drexel study, which analyzed all proposed and enacted vaccine legislation at the state level between 2011 and 2017, offers one of the first in-depth pictures of the country’s vaccination policy climate.
“If you only look at current laws, that’s history. But analyzing proposed bills gives us a flavor for what’s happening now, and perhaps for what’s to come. Are we seeing trends that may be concerning for the future?” Goldstein said.
During the seven-year study period, 175 bills related to immunization exemptions were introduced in state legislatures, with the volume increasing significantly over time. In 2011, there were 14 total bills proposed, compared to 41 in 2017.
The researchers found that the majority of vaccination legislation activity between 2011 and 2017 was consolidated to four states: New Jersey (29 total bills), New York (28), West Virginia (15) and Mississippi (12). New Jersey introduced the highest number of anti-vaccination bills (24), while New York and West Virginia introduced 14.
Of the 175 vaccination bills introduced, 92 (53 percent) were classified as anti-vaccine, and 83 (47 percent) were classified as pro-vaccine. Thirteen of the total number of bills (7 percent) were signed into law.
Although the majority of proposed legislation would have expanded access to vaccine exemptions, bills that limited exemptions — meaning they eliminated or made it more difficult for parents to opt their children out of mandatory school immunization requirements — were overwhelmingly more likely to be enacted into law. Only one anti-vaccination bill, 2011 Washington bill SB5005, ultimately became law. The law broadened the types of health care providers, beyond licensed physicians, who could sign a vaccination exemption form.
Pro-vaccine laws are an important protector for the public’s health, according to Goldstein, because such a high proportion of the population needs to be vaccinated to prevent an outbreak of contagious diseases. Measles, for example, require about 95 percent of the population to be immunized. Those who choose not to vaccinate their children for non-medical reasons are putting communities at risk, evidenced by states across the country experiencing record-high disease outbreaks this year, Goldstein said.
The recent anti-vaccination movement gained momentum after a study published in The Lancet in 1997, which suggested a link between the MMR (measles, mumps and rubella) vaccine and autism spectrum disorder. The study was subsequently debunked and retracted, and its author, Andrew Wakefield, lost his medical license.
However, that has not stopped a small, vocal minority of Americans from continuing to spread misinformation about the perceived health risks of vaccines. And Goldstein’s recent study shows that the dangerous rhetoric has found its way into state legislatures.
New Jersey Assembly Bill 497, for example, would have exempted children under six years of age from the hepatitis B vaccine requirement if the child’s mother tested negative for hepatitis B during her pregnancy. The bill explicitly linked “multiple sclerosis, chronic arthritis, autism spectrum disorder, and diabetes” as a “diseases or adverse unintended consequences associated with receipt of the hepatitis B vaccine.” There is no scientific evidence to support the bill’s claims, Goldstein said.
“Several of the bills we saw were clearly not evidenced-based,” he added. “This serves as an opportunity for pro-vaccination constituents to become involved in the legislative process and ensure that state laws reflect the state of science.”
Jonathan Purtle, DrPH, an assistant professor at Drexel’s Dornsife School of Public Health, and Joanna S. Suder, JD, deputy attorney general at the Delaware Department of Justice, co-authored this paper.
Story Source:
Materials provided by Drexel University. Note: Content may be edited for style and length.
Journal Reference:
  1. Neal D. Goldstein, Joanna S. Suder, Jonathan Purtle. Trends and Characteristics of Proposed and Enacted State Legislation on Childhood Vaccination Exemption, 2011–2017. American Journal of Public Health, 2018; e1 DOI: 10.2105/AJPH.2018.304765
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Cancer drug may help treat human papillomavirus infections


Preclinical experiments by University of Alabama at Birmingham researchers suggest the cancer drugs vorinostat, belinostat and panobinostat might be repurposed to treat infections caused by human papillomaviruses, or HPVs.
HPV infections caused an estimated 266,000 deaths from cervical cancer worldwide in 2012, according to the World Health Organization. Routine screening by Pap smears or HPV DNA tests has reduced death rates in developed countries compared to less developed regions of the globe. Still, an estimated 12,200 United States women are diagnosed with cervical cancer each year.
Highly efficacious vaccines against HPV infection exist — including the recently approved Gardasil 9, which immunizes against nine genotypes of HPV known to cause cervical, vulvar, vaginal and anal cancers, and genital warts. But the vaccine needs to be given before a person becomes sexually active, since it has no therapeutic efficacy against existing HPV infections.
“Safe, effective and inexpensive therapeutic agents are urgently needed,” said N. Sanjib Banerjee, Ph.D., assistant professor of Biochemistry and Molecular Genetics at UAB and lead author of the vorinostat study.
Epithelium of anogenital sites — the cervix, penis and anus — or epithelium of the mouth and throat are sites of HPV infection. But HPVs cannot be propagated in conventional cell culture, hampering the investigation into their pathogenic effects. The laboratory of Louise Chow, Ph.D., and Thomas Broker, Ph.D., in the UAB Department Biochemistry and Molecular Genetics has investigated HPV-host interactions for decades. They discovered that the productive program of HPV depends on differentiation of the epithelium into a full-thickness, squamous epithelium. Furthermore, HPV reactivates host DNA replication in these differentiated cells, such that the replication proteins and substrates become available to support viral DNA amplification.
The Chow and Broker lab re-produced a fully differentiated human squamous epithelium by culturing primary human keratinocytes at an air-media interphase for two to three weeks, a growth they call raft culture. In 2009, their lab developed a breakthrough model for a raft culture of HPV-18-infected primary human keratinocytes, allowing a robust amplification of HPV-18 DNA and production of infective viral progeny. This productive raft culture is an ideal model for preclinical investigation of potential anti-HPV agents.
Banerjee and colleagues hypothesized that inhibitors of histone deacetylases, or HDACs, would inhibit HPV DNA amplification because of their known mechanism of disrupting chromosomal DNA replication. Chromosomal replication requires HDAC alterations of histone proteins, the proteins that act like spools that wind DNA to help package and condense chromosomes and the viral genome. Vorinostat inhibits many HDACs, so it might interrupt not only chromosomal replication but also viral DNA replication.
Using the HPV-18 model raft cultures, the researchers found that vorinostat effectively inhibited HPV-18 DNA amplification and virus production. Importantly, vorinostat also induced the programmed cell death called apoptosis in a fraction of the differentiated cells. Cell death could be attributable to DNA breakage when chromosomal DNA replication was interrupted. Similar results were obtained with two additional HDAC inhibitors, belinostat and panobinostat. In contrast, the differentiated cells of uninfected raft cultures, which do not replicate their DNA, were thus largely spared in the presence of the inhibitors.
The UAB team also examined how vorinostat affected levels and functions of viral oncoproteins, and they described the mechanisms that led to programmed cell death in HPV-18-infected cultures. “On the basis of these detailed studies,” Banerjee said, “we suggest that HDAC inhibitors are promising compounds for treating benign HPV infections, abrogating progeny production and hence interrupting infectious transmission.”
The UAB team also reported that vorinostat caused extensive cell death in raft cultures of dysplastic and cancer cell lines harboring HPV-16. HPV-16 and HPV-18 are the most prevalent, high-risk HPVs responsible for causing anogenital and oropharyngeal cancers. “But further investigation would be required to verify that these agents could also be useful in treating HPV associated dysplasias and cancers,” Banerjee said.
Story Source:
Materials provided by University of Alabama at Birmingham. Note: Content may be edited for style and length.
Journal Reference:
  1. N. Sanjib Banerjee, Dianne W. Moore, Thomas R. Broker, Louise T. Chow. Vorinostat, a pan-HDAC inhibitor, abrogates productive HPV-18 DNA amplification. Proceedings of the National Academy of Sciences, 2018; 115 (47): E11138 DOI: 10.1073/pnas.1801156115
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Zapping tumors in less than a second


Researchers at SLAC and Stanford are developing new accelerator-based technology that aims to speed up cancer radiation therapy by hundreds of times and make related medical devices more compact. The approach could reduce side effects in patients and possibly make radiation therapy more accessible around the world.
Credit: Greg Stewart/SLAC National Accelerator Laboratory
New accelerator-based technology being developed by the Department of Energy’s SLAC National Accelerator Laboratory and Stanford University aims to reduce the side effects of cancer radiation therapy by shrinking its duration from minutes to under a second. Built into future compact medical devices, technology developed for high-energy physics could also help make radiation therapy more accessible around the world.
Now, the SLAC/Stanford team has received crucial funding to proceed with two projects to develop possible treatments for tumors — one using X-rays, the other using protons. The idea behind both is to blast cancer cells so quickly that organs and other tissues don’t have time to move during the exposure — much like taking a single freeze frame from a video. This reduces the chance that radiation will hit and damage healthy tissue around tumors, making radiation therapy more precise.
“Delivering the radiation dose of an entire therapy session with a single flash lasting less than a second would be the ultimate way of managing the constant motion of organs and tissues, and a major advance compared with methods we’re using today,” said Billy Loo, an associate professor of radiation oncology at the Stanford School of Medicine.
Sami Tantawi, a professor of particle physics and astrophysics and the chief scientist for the RF Accelerator Research Division in SLAC’s Technology Innovation Directorate, who works with Loo on both projects, said, “In order to deliver high-intensity radiation efficiently enough, we need accelerator structures that are hundreds of times more powerful than today’s technology. The funding we received will help us build these structures.”
Blasting cancer with X-rays
The project called PHASER will develop a flash delivery system for X-rays.
In today’s medical devices, electrons fly through a tube-like accelerator structure that’s about a meter long, gaining energy from a radiofrequency field that travels through the tube at the same time and in the same direction. The energy of the electrons then gets converted into X-rays. Over the past few years, the PHASER team has developed and tested accelerator prototypes with special shapes and new ways of feeding radiofrequency fields into the tube. These components are already performing as predicted by simulations and pave the way for accelerator designs that support more power in a compact size.
“Next, we’ll build the accelerator structure and test the risks of the technology, which, in three to five years, could lead to a first actual device that can eventually be used in clinical trials,” Tantawi said.
The Stanford Department of Radiation Oncology will provide about $1 million over the next year for these efforts and support a campaign to raise more research funding. The Department of Radiation Oncology, in collaboration with the School of Medicine, has also established the Radiation Science Center focusing on precision radiation treatment. Its PHASER division, co-led by Loo and Tantawi, aims to turn the PHASER concept into a functional device.
Making proton therapy more agile
In principle, protons are less harmful to healthy tissue than X-rays because they deposit their tumor-killing energy in a more confined volume inside the body. However, proton therapy requires large facilities to accelerate protons and adjust their energy. It also uses magnets weighing hundreds of tons that slowly move around a patient’s body to guide the beam into the target.
“We want to come up with innovative ways to manipulate the proton beam that will make future devices simpler, more compact and much faster,” said Emilio Nanni, a staff scientist at SLAC, who leads the project with Tantawi and Loo.
That goal could soon be within reach, thanks to a recent $1.7 million grant from the DOE Office of Science Accelerator Stewardship program to develop the technology over the next three years.
“We can now move forward with designing, fabricating and testing an accelerator structure similar to the one in the PHASER project that will be capable of steering the proton beam, tuning its energy and delivering high radiation doses practically instantaneously,” Nanni said.
Quick, effective and accessible
In addition to making cancer therapy more precise, flash delivery of radiation also appears to have other benefits.
“We’ve seen in mice that healthy cells suffer less damage when we apply the radiation dose very quickly, and yet the tumor-killing effect is equal to or even a little bit better than that of a conventional longer exposure,” Loo said. “If the result holds for humans, it would be a whole new paradigm for the field of radiation therapy.”
Another key objective of the projects is to make radiation therapy more accessible for patients worldwide.
Today, millions of patients around the world receive only palliative care because they don’t have access to cancer therapy, Loo said. “We hope that our work will contribute to making the best possible treatment available to more patients in more places.”
That’s why the team is focusing on designing systems that are compact, power-efficient, economical, efficient to use in the clinical setting, and compatible with existing infrastructure around the world, Tantawi said: “The first broadly used medical linear accelerator design was invented and built at Stanford in the years leading up to the building of SLAC. The next generation could be a real game changer — in medicine and in other areas, such as accelerators for X-ray lasers, particle colliders and national security.”
Peter Maxim at Stanford (now director of radiation oncology physics at Indiana University) is a co-inventor of PHASER and made key contributions to both projects. Additional members on the proton therapy team are Reinhard Schulte at Loma Linda University and Matthew Murphy at Varian Medical Systems.
Story Source:
Materials provided by DOE/SLAC National Accelerator Laboratory. Original written by Manuel Gnida. Note: Content may be edited for style and length.
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Opioid Use Not Tied to Increase of In-Hospital Sickle Cell Mortality


The use of opioids was not associated with in-hospital mortality among U.S. patients with sickle cell disease (SCD), researchers said here.
Based on an evaluation of data from the National Inpatient Sample (1998-2013, hospitalizations for patients with SCD were identified and hospitalization and in-hospital mortality rates for the entire cohort of patients, as well as different age groups (0-17 years, 18 — 44, 45-64, and ≥65), were identified, explained Oladimeji Akinola Akinboro, MBBS, of Boston University School of Medicine and Boston Medical Center, and colleagues.
They also looked at in-hospital mortality hospitalization rates by U.S. Census Bureau regions, the authors reported at the American Society of Hematology annual meeting.
Akinboro’s group identified 1,775,2220 hospitalizations among SCD patients from 1998 to 2013. While hospitalization rates declined by an average of 9.9% annually from 1998 to 2002 — 39/100,000 persons in 1998 to 27/100,000 persons in 2002 — no significant temporal trends were seen between 2002 and 2013.
The researchers said the findings suggested that despite the ongoing opioid epidemic in the U.S., the number of opioid-related deaths among SCD patients was low, and that the use of opioids for pain control in SCD is safe.
However, the did find a significant increase in hospitalizations in patients ages 18-44 over that time, from 43/100,000 in 2002 to 71/100,000 in 2013. The elderly age group (≥65) also saw the number of hospitalizations increase by 6.5% annually, resulting in the number of hospitalizations doubling in that age group (2.7/100,000 in 1998 to 5.4/100,000 in 2013).
Akinboro pointed out the driver behind the majority of hospitalizations in patients with SCD is a vaso-occlusive crisis marketed by intermittent, unexpected episodes of excruciating pain.
Considering that opioids are the mainstay of chronic pain control in SCD, and that the country has seen a marked increase in opioid-related overdoses and deaths this century, the authors examined hospitalization trends and in-hospital mortality rates among SCD patients, and compared them with rates of opioid prescription-related deaths among the non-SCD population since the beginning of the opioid epidemic.
“Hospitals and physicians have generally been careful with opioid prescriptions, whether it’s with patients with sickle cell disease, or the general population,” Akinboro told MedPage Today. “In carrying out the study, one of our concerns was that sickle cell disease might become undertreated.”
As the for the increase in hospitalization rates in the 18-44 and ages ≥65 groups, Akinboro suggested one reason could be the lack of coordinated care among those age groups, particularly when compared with pediatric SCD patients. Another possible explanation could be that patients with SCD are now living longer and may be developing comorbidities that account for more hospitalizations, he added.
The only geographical region that saw a significant increase in SCD hospitalizations was the South, with an annual increase of 3.5% between 2001 and 2011.
Significantly, the in-hospital SCD mortality rate remained steady through 2013, while the number of non-SCD opioid prescription-related deaths increased by 350% over the same time.
“While we didn’t look directly at opioid prescription patterns for sickle cell disease, what our study uniquely shows is that, using this large nationwide database, that deaths in a hospital setting related to opioid toxicity or overdose almost never happen among those with sickle cell disease,” said Akinboro. “This suggests that current patterns of opioid use in this population is safe, assuming we continue the same risk-mitigation strategies.”
John J. Strouse, MD, PhD, of Duke University Medical School in Durham, N.C., said that a potential concern is that deaths from opioid overdose often occur outside of the hospital, “and therefore would not increase hospital mortality.” Strouse was not involved in the study.
In a 2016 article in Pain Medicine, researchers looked at data (1999-2013) from the CDC Multiple Cause of Death Database, and determined that in 2008, 14,795 individuals (not including SCD patients) died due to opioid pain relief overdose, compared to just five patients with SCD.
That same trend was seen every year between 1999 and 2013, with 10 being the highest number of deaths due to SCD and opioid overdose.
“The current national opioid phobia may, unwittingly, deny opioids to patients who really need them, especially those patients who experience recurrent episodes of acute pain such as patients with SCD,” the authors of the 2016 article noted.
Akinboro and co-authors disclosed no relevant relationships with industry.
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Zogenix Presents Positive Findings at American Epilepsy Society


Data Presented During Late-Breaker Session at 72nd American Epilepsy Society Annual Meeting
Additional New Analyses Underscore Psychosocial Burden on Family
Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare diseases, today announced results from a post-hoc analysis of its investigational drug, FINTEPLA® (ZX008), on caregiver-reported everyday executive function in children and young adults with Dravet syndrome, who participated in the Company’s first pivotal Phase 3 clinical trial, Study 1. These data, as well as results from two analyses assessing the impact of Dravet syndrome on patients’ siblings and caregivers, will be presented during the 72nd American Epilepsy Society (AES) Annual Meeting taking place in New Orleans. Full posters can be found on http://www.zogenix.com here.
In Study 1 (poster 2.406), of the 119 total patients in the trial, 77 patients, aged 5-18 years, were assessed using the Behavior Rating Inventory of Executive Function (BRIEF®) scale. The BRIEF scale was developed to assess everyday executive function in the home and school environments for children and young adults from 5-18 years of age. The data from Study 1 were mapped to the BRIEF®2 scale, which is a more current, validated version with more stable and sensitive scales for assessing changes related to everyday executive function. Patients were randomized to one of three treatment groups: FINTEPLA 0.8 mg/kg/day (30 mg maximum daily dose; n=28), FINTEPLA 0.2 mg/kg/day (n=24) or placebo (n=25). Using the BRIEF2 scale, Reliable Change Index scores (RCIs) were calculated to evaluate whether changes from baseline to end of study in individual scores were clinically meaningful or were changes greater than expected due to measurement error, practice effects, and other factors, such as age.
Following 14 weeks of treatment, patients treated with FINTEPLA experienced clinically meaningful improvement on the Behavior Regulation and Emotion Regulation Indexes compared with those in the placebo group (p=0.02). A significantly greater proportion of patients in the pooled FINTEPLA treatment group also showed benefit on the Plan/Organize scale of the Cognitive Regulation Index compared with the placebo group (p<0.04). No significant, clinically meaningful differences were observed among the treatment groups for worsening of everyday executive function.
“The clinically meaningful impact of FINTEPLA on behavioral and emotional regulation is encouraging, as these are considered the ‘building blocks’ necessary for higher-level cognitive function,” said Gerard A. Gioia, Ph.D., Division Chief, Neuropsychology, Children’s National Health System, Rockville, MD, co-author of the BRIEF and BRIEF2 scales. “Ongoing studies will be important for fully evaluating the longer-term impacts of FINTEPLA treatment on executive function.”
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Novartis: Revolade improves outcomes in ITP vs. other second-line therapies


* Revolade (eltrombopag) showed lower rate of bleeding-related episodes and similar rate of thrombotic events vs. romiplostim, rituximab and splenectomy, in a retrospective analysis of US electronic health records
* Patients who received splenectomy, as second-line regimen, showed highest platelet counts and most frequent thrombotic event rates among groups receiving other therapies
* Immune thrombocytopenia (ITP) is a rare blood disorder where there is an increased risk of bleeding due to a low number of platelets
Novartis announced results of a retrospective, real- world evidence study in patients with immune thrombocytopenia (ITP) treated with Revolade(® )(eltrombopag), compared to other second-line therapies. The data demonstrated that patients experienced better clinical outcomes with Revolade, in terms of fewer bleeding episodes. The data were presented during the 60(th) Annual Meeting of the American Society of Hematology (ASH) in San Diego.
“Despite advances in treating immune thrombocytopenia, many patients remain at risk for bleeding episodes,” said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. “With these kind of real-world data, we can reimagine care by more clearly understanding the outcomes of a range of treatments and, in turn, helping healthcare providers better navigate available options with their patients.”
Electronic health records (EHR) data from January 1, 2009 to September 30, 2016 from the Optum(®) EHR database were used to evaluate the effect of second-line agents for ITP. Identified patients had the following characteristics: 18 years or older, evidence of previous treatment with steroids or immune globulin products, and activity in the database for at least 6 months prior to and 12 months post initiation of a second-line agent. Treatment outcomes evaluated included platelet counts, bleeding related episodes (BREs), and thrombotic events (TEs) over the 12-month period following starting a second-line therapy.
Of the 2,526 adults that met the inclusion criteria, 110 (4.4%) received eltrombopag, 189 (7.5%) romiplostim, 1,488 (58.9%) rituximab, and 260 (10.3%) splenectomy, with the remaining 479 (18.9%) receiving a mix of other second-line agents. Compared to baseline, platelet counts increased in all treatment cohorts. The proportion of patients who experienced BREs ranged from 25.5% (eltrombopag) to 36.5% (romiplostim), while TEs were observed in all treatment cohorts ranging from 11.6% (eltrombopag) to 15.7% (splenectomy). An additional analysis demonstrated that patients with ITP who had a splenectomy as second- line treatment had the highest mean platelet counts during the first 12 months post treatment initiation, but were at greatest risk for TEs (15.7%) (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, and pulmonary embolism) compared to 11.6% (eltrombopag), 12.7% (romiplostim), and 13.9% (rituximab).
“These real-world data can help doctors as they weigh options for second-line therapy with their patients.” Adam Cuker, MD, Assistant Professor of Medicine at the University of Pennsylvania. “They may also help explain the long-term trend toward deferring splenectomies until after other lines of treatment have been tried.”
Immune thrombocytopenia is a rare and potentially serious blood disorder where there is an increased risk of bleeding due to a low number of platelets. As a result, patients with ITP experience bruising, bleeding and, in rare cases, serious hemorrhage that can be fatal.[1] The goal of treatment in chronic/persistent ITP is to maintain a safe platelet count that reduces the risk of bleeding.[1]
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Takeda: Positive Data in 1st Pivotal Phase 3 Trial of Proteasome Inhibitor at ASH


– Maintenance Therapy with NINLARO™ (ixazomib) Improved Progression-Free Survival in Adult Patients with Multiple Myeloma Following Autologous Stem Cell Transplant –
– Data will be presented at the 60th American Society of Hematology (ASH) Annual Meeting on December 2, 2018 –
Takeda Pharmaceutical Company Limited (TSE:4502) today announced that data from the Phase 3 randomized, TOURMALINE-MM3 study evaluating the effect of single-agent oral NINLARO™ (ixazomib) as a maintenance therapy in adult patients diagnosed with multiple myeloma who previously responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT) will be presented at the 60th American Society of Hematology (ASH) annual meeting on Sunday, December 2, 2018 in San Diego, California. NINLARO is currently not approved as a maintenance therapy for multiple myeloma following ASCT.
The trial achieved its primary endpoint with NINLARO resulting in a statistically significant improvement in progression-free survival (PFS) versus placebo in adult patients diagnosed with multiple myeloma who responded to HDT and ASCT as assessed by an Independent Review Committee (IRC) (HR 0.72; p-value=0.002). This corresponds to a 28 percent reduction in risk of progression or death and a 39 percent improvement in PFS with NINLARO compared with placebo. The safety profile of NINLARO in the maintenance setting is consistent with previously reported results of single-agent NINLARO use.
“A growing body of evidence has shown that maintenance therapy in multiple myeloma may prolong the duration of disease control,” said Meletios Dimopoulos, MD, Professor and Chairman of the Department of Clinical Therapeutics at the University Athens School of Medicine, Athens, Greece. “As currently approved options are limited and do not include a proteasome inhibitor, there is a need for additional maintenance treatments that can sustain response and have a tolerable safety profile. Data from the TOURMALINE-MM3 clinical trial supports single-agent NINLARO as a potential oral proteasome inhibitor maintenance therapy option post-ASCT.”
“The positive results from this pivotal study – the first and only Phase 3 placebo controlled study evaluating a proteasome inhibitor in this setting – support NINLARO as a potential maintenance therapy for patients who have undergone a stem cell transplant,” said Jesús Gómez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “It is crucial that we continue to support patients by developing treatment options aimed to maintain or deepen response and delay disease progression. According to the findings, patients treated with NINLARO had improved progression-free survival over those in the control arm, which corresponds to a reduced risk of progression or death of nearly one-third.”
“As a result of continued research, the multiple myeloma treatment landscape is constantly evolving. While this is encouraging news for the multiple myeloma community, there is still work to be done to further our goal of addressing the unmet needs of patients,” said Brian GM Durie, M.D., Chairman of the Board, International Myeloma Foundation. “To that end, the development of additional safe and effective maintenance therapies is essential.”
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