Category Archives: Clinical Trials

AbbVie trial backs chemo-free Imbruvica combo regimen

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The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news

Prothena guts workforce by more than half, after trial failure

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Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials for its lead candidate.

The company subsequently ditched NEOD001, when trials revealed that placebo treatment outperformed the drug candidate in the treatment of AL amyloidosis.

The reorganisation sees 63 positions cut away from the Dublin-based company, representing a shedding of 57% of the entire staff at the company.

As is usually the case, the process was necessitated to stymie cash losses during 2018 – it projected its estimated net cash burn for the year to be $40 million to $50 million, driven by a net loss of $170 million to $185 million.

Luckily for the biotech, it’s had some backers that were betting that its work would produce results and so estimates that it still have a relatively healthy $421 million in cash to end the year on.

One notable backer is renowned UK investor, Neil Woodford, who had to defend his investment in biotech in a blog post immediately after the trial failures were announced – pointing out strengths from within the Prothena’s pipeline and suggesting its partnership with Roche was one reason to keep faith with the biotech.

In the announcement regarding its restructuring, Prothena followed suit, with Gene Kinney, President and Chief Executive Officer of Prothena, saying: “As we move forward, we have the resources to support the advancement of our pipeline through meaningful milestones and we will focus on developing neuroscience programs that we believe have a potential to offer significant benefit to patients. This includes our two clinical-stage programs PRX002/RG7935, currently in Phase 2 development in the PASADENA study in patients with early Parkinson’s disease, and PRX004, which recently initiated a Phase 1 study in patients with ATTR amyloidosis.”

PRX002/RG7935 is both being developed in collaboration with Roche and there will be significant hopes placed on this candidate to pull the biotech out of a tricky spot; however, with the treatment being for patients with Parkinson’s disease, it’s a fairly risky bet given the dearth of disease-modifying treatments for the condition.

SOURCE: www.pharmafile.com/news/517476

Eczema drug effective against severe asthma

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Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies.

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies. Dupilumab, an injectable anti-inflammatory drug, was approved in 2017 by the Food and Drug Administration as a treatment for eczema, a chronic skin disease.

The more than 2,000 patients enrolled in the studies suffered from moderate to severe asthma. All used standard asthma inhalers, and some also took oral steroids to control their severe asthma symptoms.

In one study, the rate of asthma exacerbations was almost cut in half for those taking dupilumab compared with those taking a placebo. On average, patients taking a placebo had close to one exacerbation per day during the year of the study. Exacerbations are periods of sudden worsening of asthma symptoms such as wheezing, coughing, shortness of breath and tightness in the chest.

Although the drug significantly reduced asthma symptoms for all patients, dupilumab worked particularly well in patients with high numbers of a specific type of white blood cell, called eosinophils, circulating in the bloodstream. For those patients, asthma exacerbations were cut by two-thirds.

“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” said Dr Mario Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine. “That’s important because these patients have a chronic disabling disease that worsens over time with the loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they don’t improve lung function.”

The first study included about 1,900 patients of at least 12 years of age and with moderate to severe asthma requiring they use at least three different inhalers to control their symptoms. One inhaler contained a corticosteroid that reduces inflammation, another contained a long-acting bronchodilator that relaxes airway muscles, and the third was a “rescue” inhaler filled with albuterol, a short-acting bronchodilator that quickly opens up the airway in the event of a more severe asthma attack.

Patients taking these inhaled medications then were randomly assigned to receive either dupilumab or a placebo for one year. Patients receiving dupilumab — an injectable antibody — also were randomly assigned to a higher or lower dose of the drug. Neither patients nor their doctors knew whether they were receiving the drug or the placebo.

In addition to reduced symptoms, the patients receiving dupilumab showed improved lung function in a test of “forced expiratory volume.” This test measures the amount of air a person can force from the lungs during a deep exhale. Patients receiving dupilumab, regardless of dose, improved their lung function by approximately 130-200 millilitres greater than those receiving the placebo. In general, there were no significant differences between the patients receiving high and low doses of dupilumab.

Rates of emergency room (ER) visits and hospitalisations also were improved for patients receiving the drug. In the placebo group (with 638 patients), on average, 6.5 percent of the patients required an emergency room visit or hospitalisation due to asthma during the study. In the dupilumab group (with 1,264 patients), on average, 3.5 percent of patients needed emergency care or hospitalisation due to asthma.

Based on the second study, Dr Castro said another benefit of the drug could be the ability to wean severe asthma patients off of chronic oral steroids, which can cause debilitating long-term side effects, including stunted growth, diabetes, cataracts and osteoporosis. The second study included about 200 patients using the same inhaled asthma medications as patients in the larger trial, plus additional oral steroids — usually prednisone — to control their more severe symptoms. Half of the patients receiving dupilumab in this study were able to completely eliminate prednisone use. And 80 percent of dupilumab-treated patients were able to at least cut their doses in half. Patients on placebo also reduced prednisone use but to a lesser degree, likely because the protocols of participating in a clinical trial help asthma control generally.

Dr Castro said doctors would like to help patients rely less on steroids for asthma control because those with severe asthma can be forced to take these drugs for decades to enable them to breathe.

“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe they can no longer function in the workplace,” Dr Castro said. “I’m excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies and they still can’t breathe. It can become a very disabling disease.”

Patients receiving dupilumab did experience known side effects of the drug, including pain and swelling at the injection site and a short-term bump in the number of eosinophil cells in the blood. Five patients who received dupilumab and three patients who received placebo died during the study period. According to the investigators and descriptions of these patients’ medical histories, all suffered from multiple severe medical conditions, and none of the deaths was deemed related to the study protocol.

The studies will be published online in The New England Journal of Medicine.

SOURCE: www.europeanpharmaceuticalreview.com/news/75890

ABPI expert urges to find new ‘blockbuster treatments’ for brain tumors

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With the Government set to invest an additional £20 million into the research, diagnosis and development of treatments for brain tumours, we need to talk more about how we are going to find the next blockbuster treatments for these devastating diseases.

Nearly 11,500 people are diagnosed with a brain tumour every year in the UK with fewer than 15% surviving beyond 10 years. This week’s announcement from the from the Department of Health and Social Care – following the death of Dame Tessa Jowell – that they would be doubling investment for brain cancer research to £40 million is a welcome commitment to helping achieve a goal our industry shares: finding innovative new treatments and cures for these diseases.

The science is advancing in laboratories here in the UK and around the world, funded and supported by charities, universities and the pharmaceutical industry, collectively we are working to fight back against this terrible disease.

Among the 7,000 medicines currently being developed by the global pharmaceutical industry, there are 58 medicines in the pipeline for brain tumours, including gliomas. Companies are actively working to find better ways to speed up medicines development to get treatments to patients sooner.

In her speech to the House of Lords in January, Dame Tessa Jowell talked candidly about her glioblastoma diagnosis and called for greater collaboration in the fight against cancer. She also talked about the speeding up of drug trials by testing more than one at a time, saying: “I am not afraid, but I am fearful that this new and important approach may be put into the ‘too difficult’ box.”

The type of clinical trials Tessa Jowell talked about have many different names: adaptive randomisation, drop-the-loser, adaptive dose-finding, adaptive seamless and the list goes on.

The one thing they all have in common is flexibility. In trials like this – that we call adaptive design clinical trials – researchers can see how patients are responding to treatments and then change or stop parts of the trial in real time.

When used appropriately, trials like this may improve efficiency, reduce cost, maximize information gained and minimize risk to the patients and sponsors. Ultimately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients. The UK is seen as a pioneer of innovative clinical trials and this involves collaboration between academia, the NHS, industry and medical research charities –  we must ensure we keep it that way in the future.

The issue is that these clinical trial types are not easy to design, plan or execute. An adaptive design will not rescue a poorly planned trial or ineffective treatment.

We need to make sure the regulatory authorities in the UK are not seen as a barrier to innovation; the MHRA and HRA are open to discussion and we need to encourage researchers and pharmaceutical companies to start conversations with them early in the process of planning an innovative clinical trial.

We think that adaptive design clinical trials could be the solution to speeding up the research and development of not only brain tumor treatments, but for all sorts of diseases. Research into small or rare patient populations could really benefit from these trials since they help us quickly rule out the drugs or drug combinations that aren’t working and give more patients the option to contribute to research and clinical trials.

We’re not alone. In February, the Department of Health and Social Care published their brain tumor research report which stated that, because brain tumors are one of the areas that have small patient populations, we need to think differently about how we conduct clinical trials and incorporate innovative trial designs.

The report provided practical recommendations for how we can work collaboratively to make quicker progress in this area. The next steps are to build on the UK’s existing strengths, ensure we have access to researchers with the right skills, and make sure that the right infrastructure is in place for us to make really make progress in this area.

Alongside their funding announcement, we welcome the Government’s commitment this week to accelerate the use of adaptive design trials. When used appropriately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients – and that’s where the real benefit lies.

As we look to the future of cutting-edge research and development for blockbuster treatments, we know we need to make the case for innovative clinical trial design, talk more about the amazing science our researchers, companies and NHS are pioneering and encourage them to have open conversations with the UK regulators to ensure that innovative clinical research is safe and effective.

Together, we won’t rest until devastating brain tumours are a thing of the past.

SOURCE: www.news-medical.net/news

Ipsen receives European first-line approval for Cabometyx

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Ipsen has revealed that it has received approval for the use of Cabometyx for first-line use in patients with advanced renal cell carcinoma (RCC).

The approval builds on the second line approval it had previously received in 2016, although negotiations with numerous European countries over the price of medicine have delayed access for many nations until recently.

NICE gave approval for the use of the treatment in July 2017, close to a year after its EC approval.

Though sales so far have not been blistering, recording European sales of only £25 million in the first quarter, it is expected that this first-line approval and with numerous funding agreements falling into place with payers that the drug sales will grow quickly.

Part of the reason for this is the advantage it holds over a main competitor, in BMS’ Opdivo; Cabometyx is differentiated by being available in oral form, which makes it far more convenient than having to visit a hospital for IV infusion.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”

The approval is based on results from a Phase 3 trial that hit primary endpoint of extending progression-free survival (PFS). The data revealed that PFS was improved by 8.6 months, compared with 5.3 months of patients taking Pfizer’s Sutent. In terms of overall survival (OS), the company reported that it showed a favourable, though not statistically significant, trend – as OS with Cabometyx stood at 26.6 months against 21.2 months on Sutent.

In terms of further development, Ipsen is developing the treatment as an adjunct alongside immunotherapy.

SOURCE: www.pharmafile.com/news/517387

Emergex wins Innovate UK grant to advance universal flu vaccine

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A UK biotech developing a pioneering a new approach to developing vaccines for infectious diseases has been awarded a grant of £979,318 by Innovate UK.

Emergex Vaccines says the funds will help fuel progress of its universal flu vaccine programme through preclinical development.

The vaccine is designed to target components of the influenza virus that are common to all strains, and will therefore also be suitable to target the outbreak of a new flu pandemic caused by the emergence of a novel form of the virus at the time it moves from an animal species into humans, according to the firm.

The vaccine is 100 percent synthetic and delivers “highly conserved immunogenic peptide fragments from the flu virus to antigen presenting cells in the skin, eliciting a strong and long-lasting T-cell immune response,” it said.

The grant should cover 70 percent of the cost of developing the flu vaccine programme over a period of two years, and will be used to complete preclinical toxicology and validation studies and the manufacturing of the vaccine, so that clinical batches are ready for Phase I clinical testing in the first half of 2020.

“This Innovate UK grant provides endorsement of our flu vaccine programme and reinforces our belief that an innovative approach, using the very latest technologies, could help protect the public from this inevitable epidemic or pandemic health threat,” noted Professor Thomas Rademacher, co-founder, chief executive and chief scientific officer at Emergex.

SOURCE: www.pharmatimes.com/news

Risankizumab approval could strengthen AbbVie’s market position

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According to GlobalData, if approved, risankizumab would further strengthen AbbVie’s position in the psoriasis market.

If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, according to GlobalData, a leading data and analytics company.

In 2017, AbbVie reported that Humira (adalimumab), an anti-tumour necrosis factor (TNF) biologic indicated for multiple immunological disorders including psoriasis, generated global sales of $18.42 billion, accounting for 65% of AbbVie’s total net revenue.

Risankizumab is an investigational compound that has been designed by AbbVie to selectively inhibit IL-23 by binding to its subunit p19. AbbVie has submitted a marketing authorisation application (MAA) for risankizumab to the European Medicines Agency (EMA).

Vikesh Devlia, Pharma Analyst at GlobalData, said: “With the anticipated launch of Humira biosimilars in the EU starting from October 2018, AbbVie’s position is threatened in the psoriasis market by both biosimilar erosion and other major pharma companies gaining approval for their IL-17 and IL-23 biologics.”

“This may not affect AbbVie immediately, since physicians will likely continue to prescribe Humira as one of their first-line biologic therapies for moderate-to-severe psoriatic patients. However, the less frequent dosing of IL-17 and IL-23 biologics could shift physicians to opt for these therapeutics eventually.”

“Despite these challenges, AbbVie intends to remain a player within the changing field of psoriasis treatment. With the submission of an MAA for risankizumab, the company could be closer to retaining a strong position in the psoriasis space.”

The currently approved IL-23 inhibitors for psoriasis include Johnson and Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Both Tremfya and Ilumya have been shown to have high efficacy in moderate-to-severe psoriasis.

Devlia added: “Although there are not yet any head-to-head trials comparing the efficacy of these drugs to one another, it is clear from Phase III trials that risankizumab and Tremfya will compete for best-in-class status, as both IL-23 drugs deliver high efficacy for moderate-to-severe psoriasis patients.”

SOURCE: www.manufacturingchemist.com/news

FDA approves new drug to treat MS in pediatric patients

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The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis.”

Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people with MS experience their first symptoms, like vision problems or muscle weakness, between the ages of 20 to 40. Two to five percent of people with MS have symptom onset before age 18 and estimates suggest that 8,000 to 10,000 children and adolescents in the U.S. have MS.

The clinical trial evaluating the effectiveness of Gilenya in treating pediatric patients with MS included 214 evaluated patients aged 10 to 17 and compared Gilenya to another MS drug, interferon beta-1a. In the study, 86 percent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46 percent of those receiving interferon beta-1a.

The side effects of Gilenya in pediatric trial participants were similar to those seen in adults. The most common side effects were headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.

Gilenya must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Serious risks include slowing of the heart rate, especially after the first dose. Gilenya may increase the risk of serious infections. Patients should be monitored for infection during treatment and for two months after discontinuation of treatment. A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with Gilenya. PML cases usually occur in patients with weakened immune systems. Gilenya can cause vision problems. Gilenya may increase the risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome). Other serious risks include respiratory problems, liver injury, increased blood pressure and skin cancer. Gilenya can cause harm to a developing fetus; women of child-bearing age should be advised of the potential risk to the fetus and to use effective contraception.

The FDA granted Priority Review and Breakthrough Therapy designation for this indication.

The FDA granted the approval of Gilenya to Novartis.

SOURCE: www.news-medical.net/news/20180514

SMC approves licence for liver cancer treatment

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Stivarga® (regorafenib) has been accepted by the Scottish Medicines Consortium (SMC) as a monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib).1

Regorafenib is the first medicine to be specifically licensed for second-line use in patients with HCC who had formerly been treated with sorafenib, the German multinational pharmaceutical company Bayer has announced.

The medicine is taken orally and works by slowing down the growth and spread of cancer cells by cutting off the blood supply that keeps cancer cells growing.2

Judi Rhys, chief executive of the British Liver Trustsaid: “A diagnosis of hepatocellular carcinoma (HCC) is truly devastating – it is a horrendous type of liver cancer that is often diagnosed very late with few treatment options.

“We are delighted that the Scottish Medicines Consortium (SMC) has accepted the Trust’s evidence on behalf of patients and agreed to the use of this drug for patients in Scotland.

Evidence shows that outcomes for people with advanced liver cancer are particularly poor, so this is an important step.”

She added the decision “highlights a two tier system where patients in other parts of the UK are denied access to this new treatment that can improve outcomes”.

The positive SMC announcement follows the recent decision from the National Institute for Health and Care Excellence (NICE) to not recommend the use of regorafenib on the NHS in England.3

Amanda Cunnington, head of patient access, Bayer UK said regorafenib was “the first advancement in licensed treatment for liver cancer patients in nearly a decade”and that it offers “the first and only approved second-line systemic treatment option which could significantly improve patients’ overall survival”.

Regorafenib is licensed based on data from the international, multicentre, placebo controlled Phase III RESORCE [Regorafenib after Sorafenib in patients with hepatocellular carcinoma; NCT 01774344] trial. The trial investigated patients with HCC whose disease had progressed during treatment with sorafenib.4

In the trial, regorafenib plus best supportive care (BSC) was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo plus BSC (10.6 vs. 7.8 months, respectively, (HR 0.62; 95% CI 0.50-0.79; p=0.000017)) which translates to a 37% reduction in the risk of death over the trial period.4

Adverse events observed in the RESORCE trial were generally consistent with the known safety profile of regorafenib.4 The most common (>=30%) treatment-emergent adverse events were hand–foot skin reaction, diarrhoea, fatigue and hypertension.4

HCC is the most common type of primary liver cancer.5 Liver cancer is a difficult-to-treat cancer with an annual mortality rate of 48,000 in the EU.6 Globally, it is the second leading cause of cancer-related deaths.6In the UK, there are over 5500 new cases of primary liver cancer diagnosed each year, which is around 15 patients each day.7

References

  1. SMC. regorafenib 40mg film-coated tablets (Stivarga®). SMC No 1316/18. Bayer plc. April 2018. Available at: http://www.scottishmedicines.org.uk/files/advice/regorafenib__Stivarga__FINAL_March_2015Revised_250315_for_website.pdf (Last accessed May 2018).
  2. European Medicines Consortium (EMC) Stivarga® Patient Leaflet. Available at: https://www.medicines.org.uk/emc/files/pil.1263.pdf (Last accessed April 2018).
  3. National Institute for Health and Care Excellence (NICE) Regorafenib for previously treated advanced hepatocellular carcinoma. Technology appraisal guidance [TA514] Published date: 21 March 2018.  Available at: https://www.nice.org.uk/guidance/ta514/chapter/1-Recommendations  (Last accessed April 2018).
  4. Stivarga® (regorafenib) Summary of product characteristics. Bayer HealthCare. September 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info… (Last accessed April 2018).
  5. Cancer Research UK. Liver Cancer Types. Available at: http://www.cancerresearchuk.org/aboutcancer/liver-cancer/types. (Last accessed April 2018).
  6. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (Last accessed April 2018).
  7. Cancer Research UK. Liver Cancer Incidence Statistics. Available at http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/livercancer/incidence#heading-Zero  (Last accessed April 2018).

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

AZ’s Fasenra stumbles in P3 for COPD

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AstraZeneca’s Fasenra arrived later on the scene than GSK rival med, Nucala, and so it needed to quickly rack up indications to mount a serious challenge – in COPD, at least, that looks more unlikely after the treatment wasn’t able to meet its primary endpoints in a Phase 3 trial.

Fasenra is already approved to treat severe eosinophilic asthma in major markets around the world but was hoping to add to this with an expansion into treating exacerbations in those with moderate to very severe COPD.

Had it succeeded to hit its endpoints, it would have joined GSK in submitting for regulatory approval but now looks set to fall behind, should its rival receive approval.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of Terranova and a full evaluation of both trials to determine next steps for Fasenra in COPD.”

GSK did not have a smooth path to acquire the data needed it to submit for approval; in its Metreo study, the drug demonstrated a reduction in exacerbations but not to a level that were statistically significant.

However, it managed to scrape successful results in another trial that was on-going concurrently (Metrex) in reducing exacerbations. It shows that these types of monoclonal antibody treatments can be hit-and-miss in trials for COPD.

Full details were not revealed by AstraZeneca about how far its drug missed the mark but, as mentioned by Bohen, the company has another trial running. If this trial succeeds and the drug only just missed the mark, it could still be emboldened to attempt to file for approval – in a similar manner to GSK.

Fasenra entered the market two years after Nucala but has some advantages that could see it leech GSK’s sales in the area; the product is administered by subcutaneous injection but is delivered every eight weeks (compared to four weeks for Nucala), after a lead-in dosing schedule and is priced at a lower level.

SOURCE: www.pharmafile.com/news/517342