Seagen Survival Data Offer New Hope for Hodgkin Lymphoma Patients

 On Thursday, Seagen shared that its Phase III trial of ADCETRIS (brentuximab vedotin) has demonstrated significant improvements in the overall survival (OS) of patients diagnosed with advanced classical Hodgkin lymphoma (cHL).

Data from Phase III ECHELON-1, an open-label, randomized clinical study conducted with 1,334 adult participants with either stage III or stage IV cHL, showed consistent improvement in OS across each of the six 28-day cycles completed. OS is the trial's key secondary endpoint, while its primary endpoint is modified progression-free survival. 

CHL is a type of blood cancer that begins when lymphocytes grow out of control. According to the American Cancer Society, about 8,450 new cases of HL will surface in 2022 and estimated that some 920 will die from the disease in the U.S. alone. 

The participants received ADCETRIS with chemotherapy for the study and were followed up after around six years. 

Seagen researchers found that those who were given ADCETRIS plus doxorubicin, vinblastine and dacarbazine (A+AVD) saw a 41% drop in their risk for death compared to the patient group that had doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). Patients were randomly assigned to each group and were given the drugs intravenously on day 1 and day 15 in a 28-day cycle. The entire study was comprised of six cycles. 

"These groundbreaking results are important for patients with advanced classical Hodgkin lymphoma given that an improvement in overall survival has rarely been shown in frontline treatment of this disease," commented Dr. Roger Dansey, the chief medical officer at Seagen, in a statement. 

ADCETRIS is an antibody-drug conjugate approved for use in some types of relapsed or refractory Hodgkin lymphoma, as well as previously untreated stage III/IV cHL and peripheral T-cell lymphoma (PTCL). It is also approved for previously untreated systemic anaplastic large cell lymphoma (sALCL), other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma, and sALCL after failing at least one prior multi-agent chemotherapy regimen, among others. 

The drug is being developed by Seagen and Takeda, who are funding joint development costs on a 50:50 basis worldwide, with the exception of Japan where only Takeda has the responsibility for the development expenses. ADCETRIS has marketing authorization in over 75 countries and is currently the subject of at least 70 clinical trials across various indications in lymphoma and other diseases. 

Details of the latest results will be shared at the company's upcoming medical meeting.

https://www.biospace.com/article/seagen-drug-for-hodgkin-lymphoma-demonstrates-high-overall-survival-in-phase-iii-trial/

China accused of ignoring hockey player’s human rights as isolation complaints grow

 The coach of the Finland men's ice hockey team accused China of not respecting a player's human rights on Sunday as complaints about Covid-19 isolation protocols piled up at the Winter Games.

Finland head coach Jukka Jalonen said Marko Anttila, a ninth round pick of the Chicago Blackhawks in the 2004 NHL draft, was "not getting good food" and under tremendous mental stress.

"We know that he's fully healthy and ready to go and that's why we think that China, for some reason, they won't respect his human rights and that's not a great situation," Jalonen said on a Zoom call with media.

Anttila was no longer infectious but continued to be kept in Covid-19 isolation after testing positive 18 days ago, according to the team doctor.

More than 350 Games participants, including dozens of athletes, have tested positive on arrival in the Chinese capital since January 23. They can only leave special quarantine hotels once they are free of symptoms and test negative in two PCR tests 24 hours apart.

Several Games participants have complained about the isolation conditions, as well as the confusing procedures around being allowed to leave. Organisers said on Sunday that they were trying to address complaints.

"We are in a process of addressing these problems," said Zhao Weidong, Beijing Games spokesperson, adding that they would now allow an athlete to order in food from the village.

On Saturday, Germany's team chief Dirk Schimmelpfennig called conditions for triple Olympic gold medalist Eric Frenzel and two other German athletes "unacceptable".

He demanded a complete overhaul including bigger and cleaner rooms, a working internet connection, sports equipment and better food.

Schimmelpfennig said on Sunday that organisers had acted after being contacted by the team, the ski federation and the International Olympic Committee.

"We have succeeded since yesterday in achieving a marked improvement in conditions for the athletes," he told reporters.

"Now the athletes have a satisfying framework of conditions. They have bigger rooms now, working wifi, an exercise bike in the room so we have appropriate and satisfying conditions in a very difficult situation for the athletes," he said.

HORROR STORY

Polish short track speed skater Natalia Maliszewska posted on Twitter that her Beijing Olympics had turned into a 'horror' story after she tested positive on Jan 30. She claimed she had received several positive and negative tests

Finally, on the day of the start (on Saturday) at 3:00 am, people pull me out of solitary ... That night was a horror.

"I slept with my clothes on because I was afraid that someone would take me to solitary in a moment again. I only looked a little through the curtains. With one eye, because I was afraid someone would see me."

Hours later, Maliszewska said she packed for the ice rink to take part in the 500 metres heats.

"And suddenly the news that they have made a mistake! That they shouldn't let me out of solitary confinement! That I am a threat after all! That I can't compete. I have to get back to the village asap."

Maliszewska's status at the Games was not immediately clear. A Polish Olympic Committee representative said he would clarify the situation later on Sunday.

Swedish journalist Philip Gadd, who was whisked off to isolation in an ambulance when he arrived in Beijing on Wednesday, described his confusion and fear in a diary he is writing for his newspaper.

"It was a really terrifying experience and it just felt like ... it didn't feel real. It felt like as if I was in a movie, a sci-fi movie or something," he told Reuters in a Zoom interview from his quarantine hotel.

https://www.independent.ie/news/china-accused-of-ignoring-hockey-players-human-rights-as-isolation-complaints-grow-41318534.html

U.S. School Shootings Spike Amid Pandemic Stress

 A 19-year-old former student was shot and killed after a high school basketball game a week ago in Beloit, Wisconsin. On Monday, a shooting outside Chaparral High School in Las Vegas left three teens hospitalized.

On Tuesday, five teenage girls were shot and injured outside Rufus King High School in Milwaukee. Also Tuesday, a student was killed and another shot outside the South Education Center in Minneapolis, the only of these cases in which suspects were arrested. Two students from the school have been charged.

Signs are emerging that the stresses and challenges of the pandemic are worsening gun violence in American schools. Researchers who are studying the phenomenon worry it will only get worse.

Already, campuses have been the site of 141 shootings so far during the 2021-22 school year - more than at any point in the previous decade, according to Everytown for Gun Safety.

Problems that predated the pandemic - such as inequality and inadequate resources - have grown worse even as COVID-19 has introduced new challenges, like creating such stress that half of teachers say they want to quit or retire early, according to recent surveys by the National Education Association.

What that means is there are now and will continue to be fewer adults connected to students who can see warning signs that a child may be heading toward violent behavior.

"Kids are walking into a system that has been massively weakened," said Ron Avi Astor, a school violence expert at UCLA. "We're going to see a variety of different forms of gun violence and violence in general. We're in a situation where things are going to get worse."

Astor said there are myriad factors behind the violence, among them the pandemic, increases in overall community violence and breakdowns in family structures. All those issues have created a "tsunami of mental health needs" in schools, he said. And the problems are cresting as teachers and administrators are ill-equipped to deal with them because of burnout, lack of staff and illness.

The problem is not necessarily too little funding, Astor said, but the missing human capital -- teachers, specialists and staff who could help tackle the crisis of violence.

BROKEN ROUTINES, MANY GUNS

Katherine Schweit, a retired FBI special agent who focused on active shooters and author of the book "Stop the Killing" published last year, said another key factor in the violence has been parents' erratic schedules in the pandemic. This means less oversight and less predictable routines for kids, making it even more difficult for parents, teachers and others to see warning signs.

"One of the things that we focus on when we talk about preventing shootings … is what is different in someone's routine that might indicate to us that this person is on a trajectory towards violence," she said. "But who has a routine these days? Nobody."

The availability of guns is another factor, according to Jillian Peterson, a criminology professor at Hamline University and co-creator of the Violence Project research center. The past year saw consistent monthly record gun sales, though purchases have begun to ebb. Peterson said far too many of those guns are not secured in homes, allowing teens access.

One of the most important things schools can do right now, Peterson said, is create crisis response systems and teams so that students and teachers can report their concerns about specific students. This information can be funneled to people trained to evaluate the threats.

Peterson said that while it is impossible to know exactly what is driving increases in violence, researchers agree the decimation of school services is a big contributor.

"We know that a lot of things that prevented violence, like after-school programs and sports, are still not up and functioning in many places," she said.

"The pandemic," Peterson added, "has shown us that schools are so much more than schools. They really hold our society together and hold our kids together in many ways, from mental health to physical health to food security. And we lost that."

https://www.usnews.com/news/top-news/articles/2022-02-06/tsunami-of-woes-u-s-school-shootings-spike-amid-pandemic-stress

UCB preps filings for another challenger to AZ’s Soliris

 Belgian drugmaker UCB says it will be able to file not one but two new drug therapies for autoimmune disease generalised myasthenia gravis (gMG) this year, after its C5 inhibitor zilucoplan hit the mark in a phase 3 trial.

Zilucoplan achieved a significant improvement in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score compared to placebo at week 12 in the RAISE trial, which UCB said was a “clinically meaningful” result.

Regulatory filings for the drug will now take place later this year, alongside anti-neonatal FC receptor (FcRn) antibody rozanolixizumab which met its objectives in the phase 3 MycarinG trial in December.

If approved, the two drugs will place pressure on AstraZeneca’s $4 billion blockbuster gMG therapy Soliris (eculizumab), which it acquired as part of its $39 billion takeover of Alexion.

Soliris and AZ’s follow-up drug Ultomiris (ravulizumab) are also C5-inhibiting antibodies, but need to be dosed by intravenous infusion once every two or eight weeks, respectively. In contrast, zilucoplan is a peptide that can be taken once-daily as a subcutaneous injection, so can be self-administered by patients at home.

UCB acquired rights to the drug when it bought US biotech Ra Pharma in a deal worth around $2.1 billion in 2019, and is also developing the drug for paroxysmal nocturnal haemoglobinuria (PNH), another of Soliris and Ultomiris’ FDA-approved indications.

Ultomiris isn’t approved for gMG yet, but AZ filed for approval in the disease – which causes severe weakness and fatigue in muscle – last December, and could have a verdict from the FDA in the second quarter of this year.

Analysts at Evaluate have predicted that zilucoplan and rozanolixizumab could struggle to make headway in an increasingly competitive market, estimating 2026 sales of $376 million and $349 million, respectively.

One factor is the fast growth of Ultomiris, which breached the $1 billion sales threshold in 2020 and has been growing at a healthy lick during 2021, but there are a number of other rival therapies looming.

That includes Argenx’ anti-FcRn drug Vyvgard (efgartigimod alfa) – another IV drug which was approved for gMG by the FDA in December – and Apellis Pharma’s C3 inhibitor Empaveli (pegcetacoplan) which is given by subcutaneous infusion twice-weekly using a pump device but currently cleared by the FDA only for PNH.

UCB said it will file zilucoplan and rozanolixizumab in the US, Europe and Japan, starting in the coming months, and reckons it is currently the only company investigating two potential treatments with different mechanisms of action in gMG.

https://pharmaphorum.com/news/ucb-preps-filings-for-another-challenger-to-azs-soliris/

Novavax COVID jab ‘could save UK money on boosters’

 The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future booster campaigns, according to the former chair of UK Vaccine Taskforce.

Dr Clive Dix said that Nuvaxovid has excellent clinical data and – as a it has good stability at fridge temperatures – could be easily rolled out with the flu vaccine next winter, and should “replace the need to buy more Pfizer and Moderna vaccine.”

Nuvaxovid was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) yesterday, becoming the fifth COVID-19 vaccine to be authorised in the UK. In August 2020, the UK government agreed a deal with Novavax to purchase 60 million doses of the vaccine.

It is being manufactured at a facility in Teesside owned by FUJIFILM Diosynth Biotechnologies, although a report in The Times suggests that any initial supplies will be imported from India, where it is made under license by Serum Institute.

The two-shot vaccine uses a conventional recombinant protein technology, making it more temperature stable than Pfizer and Moderna’s mRNA-based shots which have to be kept in a deep freeze.

It was shown to be 89% effective in preventing symptomatic COVID-19 in phase 3 trials carried out in the US and Mexico, in the same ballpark as its mRNA rivals.

Along with the UK, Nuvaxovid has also been approved in the EU and by the World Health Organisation (WHO), as well as other countries including Australia, New Zealand, South Korea, India and Indonesia. It was also filed in the US earlier this month after development and manufacturing setbacks.

Health Secretary Sajid Javid said the Joint Committee on Vaccination and Immunisation (JCVI) will now consider its use, and could be added to the vaccination strategy immediately if the outcome is positive.

The initial approval is in adults, but Novavax has said it will file Nuvaxovid for the over 12s in the coming weeks, as well as data on use as a booster. The shot has also been included in a UK ‘mix and match’ study to see if it can be used as third dose in people who have already received the AstraZeneca or Pfizer vaccines.

While Nuvaxovid was developed based on the spike protein of the original Wuhan strain of SARS-CoV-2, cross protection also seems to be high against variants of concern, including the new Omicron strain, according to its developer, which has also started working on a version specific to the new variant.

“We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the UK tackles this next phase of the pandemic,” said Stanley Erck, Novavax’ chief executive.

“We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the UK, as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this programme.”

https://pharmaphorum.com/news/novavax-covid-jab-could-save-uk-money-on-boosters/

Humana To Invest $1B In Medicare Advantage Business As Enrollment Falls Short

 Humana said it will spend $1 billion to “fund growth and investment” in its Medicare Advantage business following a disclosure the health insurer would add fewer seniors to such plans than expected for 2022.

The announcement came Wednesday as part of the health insurer’s fourth quarter 2021 earnings report that showed a $60 million loss, which was narrower than the year-ago period’s $458 million loss. Revenues grew 10% to $21 billion compared to $19 billion in the year-ago period.

Humana is a big player in Medicare Advantage plans that contract with the federal government to provide extra benefits and services to seniors, such as disease management and nurse help hotlines with some also offering vision, dental care and wellness programs.

But Humana last month surprised investors and the industry by disclosing it was “decreasing its net membership growth estimate for its individual Medicare Advantage products for the year ended December 31, 2022 to a range of 150,000 to 200,000 members from the previous range of 325,000 to 375,000 members.” That revised estimate was attributed to “higher than anticipated terminations” during the annual open enrollment period.

To return to growth, Humana said it will commit to “performing a critical review of ongoing strategic initiatives across the company” including evaluation of its real estate portfolio.

“This will create capacity to fund growth,” Humana chief executive Bruce Broussard told analysts Wednesday morning during a call to discuss earnings. “We are pushing the organization to be more efficient.”

Humana’s slower-than-expected growth in its Medicare Advantage business comes during perhaps the most competitive time in the history of the program due to new plans entering the business offering seniors an unprecedented number of choices. Established rivals like UnitedHealth Group, CVS Health’s Aetna health insurance unit are expanding into new markets while a flurry of startups and smaller health insurers have entered the business, seeing a market of more than 10,000 Americans a day turning 65 years old and becoming eligible for Medicare and Medicare Advantage in particular.

Broussard also said it is taking steps to make Humana’s Medicare Advantage offerings more attractive to seniors by enhancing healthcare services the plans offer. Humana last month disclosed plans to expand its physician-staffed primary care clinics into three more states, increasing to more than 240 the number of such centers the health insurer operates by the end of this year.

https://www.forbes.com/sites/brucejapsen/2022/02/02/humana-to-invest-1-billion-in-medicare-advantage-business-after-enrollment-comes-up-short/

Bobsledder Elana Meyers Taylor has 2 negative tests for COVID-19, can compete in Beijing

 Elana Meyers Taylor, the only woman to win three Olympic bobsled medals for the U.S., on Saturday said she has had two negative tests after testing positive for COVID-19 and has been cleared to compete in the Winter Games in Beijing.

Meyers Taylor, who ranks No. 1 in the world in two-man and monobob, was chosen to be a flag-bearer for the U.S. Olympic team but was unable to attend the opening ceremony after she tested positive two days after arriving in Beijing on Jan. 27.

Since testing positive, she has been in isolation at a hotel but had continued to work out. She told NBC's "Weekend TODAY" that she will move to another hotel "so I can start the process of getting back into training and getting everything ready to race" in her bobsled events.

Women's monobob official training begins Thursday, with competition beginning Feb. 13. Training for the two-woman event starts Feb. 15, with competition beginning Feb. 18.

Meyers Taylor told NBC that she has been working out in her room at the isolation hotel and that her friends and coaches have also continued to help her prepare for competition.

"They've been sending me notes on the track and doing different things like that," Meyers Taylor told NBC. "I also have tons and tons of video from our coaches who've just been doing everything they can to keep me engaged and keep me involved. So I've just been going over that as much as I can and watching video and doing whatever I can to stay ready."

Meyers Taylor, competing in her fourth Winter Olympics, has two silver medals and one bronze. She won the season-long points title in the women's World Cup in January.

https://www.espn.com/olympics/story/_/id/33222359/team-usa-bobsledder-elana-meyers-taylor-two-negative-tests-covid-19-compete-beijing-winter-olympics