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Earlier this year, when the start-up where Danielle works decided to reopen its Philadelphia office, the project manager was so anxious at the prospect that she sought the help of a therapist for the first time.

I started to get really nervous and unsure, said Danielle, 39, who lives in the city and asked that her last name not be used over worries that it could impact her career. Ive been remote this whole year. . I just have this fear what if we reopen and we become the next India? referring to the devastating outbreak there.

Even though an end to the pandemic seems to be in sight as vaccinations increase and restrictions ease, many workers are anxious about returning to the office and in-person interactions after more than a year away. And that anxiety might be short-circuiting the brains ability to cope.

Weve seen one another as threats for a year, said Michelle Pearce, a clinical psychologist and director of the Integrative Health and Wellness Certificate Program at the University of Maryland. That doesnt disappear overnight, even after you get a shot in the arm. We need to retrain our brains.

A survey released last month of 500 U.S. human resource managers found that they think employees are struggling with returning to work, with 37% of managers saying that most of their workers felt stressed about reopening and 31% saying employees were anxious about it, according to Koa Health, a digital mental health-care provider.

Many workers, of course, have had little choice but to hold the front lines of hospitals, grocery stores, and other essential industries, stress or no stress. But for remote-laboring professionals, all this angst may well be in their heads. That is, literally, the result of potential pandemic-induced changes to brains, neuroscientists said.

Normally, the amygdala, the region that processes emotions, signals when a potential threat is present. Usually, the signal is tied to a negative emotion such as fear or anger, explained Crystal Reeck, an assistant professor at Temple Universitys Fox School of Business who specializes in the psychology and neurology of decision making. That triggers a fight-or-flight response. Think about it as an alarm system, she said. It helps draw your attention to a threat in the environment.

Meanwhile, the prefrontal cortex, which is involved in decision making and social behavior, assesses the threat for example, delivering a speech in public and turns down the alarm bell, Reeck said, by reminding you that you are prepared.

Research has shown that anxious people tend to have a more active amygdala and less well-developed prefrontal cortex, hindering the regulation of the threat signal, Reeck said. During anxiety, that loop is disrupted, she said.

What does this have to do with workplace worries? Over the last year-plus, Reeck said, the amygdala may well have gotten rewired to learn new threats, such as someone coughing, or standing closer than six feet, or not wearing a mask. Thats helped keep us safe when we were supposed to quarantine and maintain a social distance, she said.

But now, as offices reopen and the Centers for Disease Control and Prevention says those who are fully vaccinated no longer need to wear masks, it may take some time to reset, Reeck said.

Consider the aftermath of the 1918 flu pandemic. According to Miami-area psychiatrist Arthur Bregman, who has researched the topic, many who lived through the earlier outbreak feared leaving their homes. They had what Bregman dubbed the Cave Syndrome, where people hunker down and are reluctant to leave home.

Most people had chronic PTSD, he said. Bregman anticipates the same kind of reaction this time around, as well. Already, he has anxious patients asking him to write notes excusing them from returning to the office, he said. Its not so easy to be isolated like we were and then go back to work. Its not like an off or on switch.

The American Psychological Associations 2021 Stress in America online poll of 2,076 U.S. adults found that prolonged stress persists at elevated levels for many Americans, with 47% feeling anxiety in the previous two weeks.

When Danielles company decided to reopen one day a week in April, with plans to go four days a week by summer, the introvert deep down said her anxiety that racing heart, those sweaty palms rose each time she walked through the office doors, as if it were the first day of school. A lot of it was fear of the unknown.

For help, she turned to hypnotherapist Alexandra Janelli, who has a Philadelphia branch of Theta Spring Hypnosis. Over three sessions, totaling about $800, Janelli suggested, while Danielle was in a hypnotic state, ways to handle specific fears, such as coworkers who forget to pull up their masks. Janelli reminded her that she was fully vaccinated and that she could step back from the person. Through hypnosis, she said, I help them build confidence and find their own solutions.

Said Danielle: I felt a huge difference. Everything Alexandra was saying was speaking to me. When she starts to feel anxious, she said, she focuses on what she can control. The anxiety goes down. Its such a relief and help.

Like many employers, Philadelphia law firm Hangley Aronchick Segal Pudlin & Schiller is studying reopening options. The firm is looking to balance the needs of the company and the concerns of individual employees, said real estate attorney David M. Scolnic, a shareholder and board member.

Based on a survey last year of its 100 employees, Hangley found that the top issue was getting to work, including the use of public transportation and the elevators to reach its offices on the 27th and 28th floors of One Logan Square. In conversations with employees, Scolnic said, that concern is still there.

The firm is also wrestling with whether to require vaccinations, how many days to ask employees to return to the office, when to reopen and so on. Its complicated, Scolnic said. You want to make sure employees are comfortable. Right now, were trying to listen very hard to what their concerns are.

As employees emerge, they may experience low energy, low motivation, irritability, and difficulty concentrating, said Pearce, at the University of Maryland. A lot of us are grieving, she said. Weve all lost something, collectively and individually.

According to David Rock, the CEO and cofounder of the global consultancy NeuroLeadership Institute, companies should take these mental health concerns seriously, creating not only physical protection but also psychological safety. Without the latter, he said, employees might get mired in anxiety and depression, hindering creativity or out-of-the-box thinking.

A companys strongest lever, Rock added, is giving workers a sense of control, and that starts with choices about returning to offices. Fundamentally, a lot of people are very anxious about going back into a world where 40% to 50% of people are not vaccinated, he said. What offsets that type of anxiety is a greater sense of control over work, of being treated fairly.

When speech therapist Abby Stern went from fully remote to spending half her time at the preschool in Media where she works, she was extremely worried. Before the pandemic, Stern suffered from panic attacks caused by a fear of getting sick. The pandemic only exacerbated her anxiety, and the prospect of in-person encounters was one more stressor, causing her stomach to hurt and heart to race.

I have kids sitting in my lap, said Stern, who returned full time in February. In the beginning, I was very nervous. My nightmare scenario was that the first day I get back, all the kids are going to be coughing, and two weeks later, half the staff will be sick.

But Stern is working through it. Her supervisor, for instance, was OK with her initially wearing two masks all the time and eating lunch in her car. She also struggled a little with how much distance to maintain while making small talk with colleagues, but that, too, eased over time, especially after she got vaccinated.

Still, Stern said, it always baffles me when people are not anxious. How can you not be worried about this?

The Future of Work is produced with support from the William Penn Foundation and the Lenfest Institute for Journalism. Editorial content is created independently of the projects donors.

More:
Returning to the office stirs anxiety among workers - The Philadelphia Inquirer

Academics rarely agree about the big issues, and generally hesitate to enter the political fray by signing collective public statements. Yet a few days ago, more than 100 leading scholars of democracy endorsed a remarkable Statement of Concern, which I also signed, warning about grave threats to American democracy and the deterioration of US elections.

We urge members of Congress to do whatever is necessary including suspending the filibuster in order to pass national voting and election administration standards that both guarantee the vote to all Americans equally, and prevent state legislatures from manipulating the rules in order to manufacture the result they want. Our democracy is fundamentally at stake. History will judge what we do at this moment.

Why the alarm? Is this warranted?

On 14 December 2020, after courts litigated challenges and all 50 states certified the count, the electoral college formally declared the defeat of Donald Trump. Most assumed that the peaceful and orderly transition in power would follow, following historical traditions for over 200 years. Instead, the world was shocked to witness the violent Capitol insurrection on 6 January, triggering five deaths, 140 people injured and more than 400 arrests.

But even this unprecedented attack on Congress was not the end of the assault on the unwritten norms and practices of American democracy and the legitimacy of Joe Bidens win.

For months, the big lie claiming a stolen election has continued to be spread relentlessly by the former president, his close advisers, Republican lawmakers and rightwing sympathizers on cable news and social media. According to many polls, two-thirds of Republicans continue to believe that Bidens victory was fraudulent. In Arizona, the Republican party hired a private firm to conduct an audit of the certified vote count.

It is reported that Trump is obsessed about the use of audits to overturn results in other close states like Pennsylvania, Wisconsin and Michigan, believing that he will be returned to office in August. In state houses, Republicans have long expressed concern about the risks of electoral fraud and the need to tighten registration procedures and balloting facilities. The Brennan Center reports that since January this year, 22 new laws restricting voting rights have been enacted in 14 states. For the 2021 legislative session, almost 400 bills restricting voting rights have been tabled in 48 states.

Challenges to democracy are increasing worldwide. The long spread of third-wave democracies across the globe from the mid-1970s stalled around 2005 since when scholars have noted accumulating indicators of democratic backsliding and rising authoritarianism in many countries.

Contrary to popular commentary, signs of democratic deterioration in America were on the wall well before Trump became president such as persistent gridlock in US Congress, deepening cultural polarization and the corrupting role of dark money in politics. The backsliding has accelerated during the last four years, with attacks on the news media, risks to the impartiality of the courts, and the weakening role of Congress as an effective check and balance on executive power.

The US electoral system has also long been problematic, notably extreme partisan gerrymandering, the composition of the electoral college, rural over-representation in the Senate, lack of electoral standards as the supreme court rolled back federal oversight of state elections established by the 1965 Voting Rights Act, low turnout and the expansion of misinformation in the media. Since Bush v Gore in 2000, serious challenges to electoral legitimacy, and growing party polarization over the rules of the game, have gradually deepened. The Electoral Integrity Project has used expert surveys to evaluate the quality of national elections around the world since 2012 and found that US elections have persistently been graded poorly by EIP experts, scoring next to last among the worlds liberal democracies, and ranking about 45th out of 166 nations worldwide.

Unfortunately, Republican federal and state lawmakers have no rational incentives to abandon Trump and the big lie about electoral fraud, even if they recognize the falsehood. Most incumbents are nominated through party primaries and hold safe districts due to partisan gerrymandering, so Republican chances of re-election depend on throwing red meat to the Maga base, not building a broader coalition among moderate independents.

What is to be done?

To fix the system, two steps are essential. Both need to be enacted before the November 2022 midterm elections, when the Democrats are likely to lose control of the Senate, if history is any guide.

First, the Senate filibuster has to go as a relic of a bygone era. Worldwide, about 41 national legislatures have some supermajority rules but in nearly all cases these are only used, quite sensibly, for constitutional amendments, not for routine legislation (like establishing the 6 January commission). The rule benefits the opposition party seeking gridlock in DC and stymies effective electoral reform.

The Senate rules are not fixed in stone and they can be amended by their own members through various procedural initiatives. The benefits of the filibuster rule for non-constitutional amendments are doubtful and the harm for gridlock has never been more serious. The Senate needs to act urgently to change its procedural rules to protect American democracy.

Second, the US Senate needs to pass the HR1 For the People Act. This offers a comprehensive package of moderate reforms designed to protect voting rights in US elections, reduce partisan gerrymandering, make campaign spending more transparent and tighten ethics in public life. Getting rid of extreme partisan gerrymandering and ultra-safe districts is vital to incentivize House candidates to appeal broadly to all citizens well beyond their base. The Senate also needs to pass HR4, the John Lewis Voting Rights Advancement Act, restoring provisions of the 1965 Voting Rights Act requiring certain states to pre-clear changes to their voting laws with the federal government, which had been struck down earlier by the US supreme court in Shelby County v Holder.

A series of other reforms are highly desirable in the long term but impractical right now.

One is adopting non-partisan blanket primaries, as in Washington and California, where the two candidates with the highest vote share get to run in the general election, irrespective of their party affiliation. This increases the incentive for all candidates to reach out to a broader constituency than the party base, so it is likely to encourage the election of more moderate lawmakers in Congress.

Another is designed to break the stranglehold on two-party winner-take-all competition, ideally by implementing a mixed-member proportional electoral system for the US House, like Germany and New Zealand, with an enlarged number of members, or ranked-choice voting in multimember districts.

Yet another reform is adopting a compulsory retirement age for members of Congress, like the minimum age requirement, to increase incumbency turnover, limit gerontocracy and expand representation for the younger generation of leaders, women and minorities.

These are all worthy matters for future debate about long-term constitutional and legal reforms to American elections, a generational project. But, in the short term, the most urgent and practical priorities right now facing the Senate majority leader, Senator Chuck Schumer, means wrangling the US Senate to abolish the filibuster rule and then to pass some version of HR 1 and HR 4. The laws would still face major challenges through the courts. But if they dont get enacted, American democracy is at risk.

The sixth of Januarywas the warning bell. The stress test of the 2022 midterm elections is fast approaching. Other countries have seen democratic breakdown. This is not alarmism. Alas, its real.

Read the original:
American democracy is at risk from Trump and the Republicans. What can be done? - The Guardian

Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, testifies before a House panel on Sept. 25, 2019. In an NPR interview, she says the nation has more work to do to get ready for a future pandemic. // Getty Images, Win McNamee

Updated June 4, 2021 at 1:04 PM ET

The United States was unprepared for the coronavirus, the response "wasn't a good performance," and there's still "a lot of work to do" to get ready for the next pandemic when it comes. That's the assessment of Dr. Anne Schuchat, the No. 2 official at the Centers for Disease Control and Prevention, who is retiring this summer after 33 years at the agency.

"This was a really complex, systemwide assault," she says in an interview on Morning Edition. "But another threat tomorrow, we're not where we need to be. We're still battling this one. And we have a lot of work to do to get better prepared for the next one. But I think there's political will that might have been missing before."

When she's asked about the political pressure she faced under former President Donald Trump, Schuchat declines to get into details.

"I would say that my work was mainly focused on directing our response to support state, local, public health, clinical partners, community groups," she says. "The political side of things, I was not after a certain point, I wasn't doing."

Schuchat also says she supports further investigations into the origins of the pandemic. "There's a lot we really do need to know here," she says. "So understanding where this came from and how it spread so easily, I think is important."

Schuchat does not quite have the public profile of Dr. Anthony Fauci, but her work as a disease detective tracing outbreaks is a part of American popular culture. Kate Winslet's character in the movie Contagion was modeled in part on Schuchat. Schuchat's career as a doctor began in the 1980s in New York City, which was a challenging time and place.

"One out of five of my patients had AIDS and they were really sick," she says. "Many of them didn't make it. You know, people came in with shortness of breath and were intubated very soon after and got a diagnosis that they didn't know they had, which at the time was essentially a death sentence."

She emerged from that time as an internist looking for something new.

As she finished her residency, she remembered hearing about the Epidemic Intelligence Service, the CDC's disease detective program.

She thought: "Maybe that would be a fun thing to do. Maybe just spending two years learning how to investigate outbreaks would be interesting and a little less intense than what I had just been through before I spend my life in practice."

But instead of returning to a medical practice, she stayed with the CDC. "I just fell in love with what we do, how we do it, the people that we work with and the impact that we can have," Schuchat says.

Below are highlights of the interview edited for length and clarity.

Looking back, did the nature of COVID-19 make it inevitable that it would be as deadly as it has proven to be?

This virus is really difficult. I think that a severe toll was going to happen, but we have seen such variation in countries and in communities' ability to counter it. And so I wish that we had not had as much loss of life and ongoing loss of life as we've had around the world. But this virus was going to be difficult under the best circumstances of response. And of course, we've had very variable response to this.

I'd like to ask about something that was commonly commented on at the height of the pandemic. People would look at a country like South Korea, where testing and tracing seemed much more effective and people were much more aggressive and successful in containing the disease. Was that ever possible in the United States?

We were not ready for that, OK. There are many things that our colleagues in Korea did that allowed them to have a very effective initial response. Our public-private smorgasbord of clinical laboratories and testing, our regulatory environment for how new lab tests can be rolled out, the public health capacity [being] very weak in terms of ability to get the contact tracing done. You know, obviously, we had problems with our test, and the academics and others who had tests couldn't use them until FDA changed their enforcement discretion.

There were just many things that delayed us. That said, there was lots of great work in many communities. But I think as a nation, it wasn't a good performance.

If it were to happen again next year, five years from now, which is plausible, would we be ready then?

We have a lot of work to do. So I think I am really encouraged by the investments and the seriousness that we're seeing in the administration, in the agencies, in the communities. You know, this has been really bad and I just hope people continue to feel that commitment to do better.

Just the public health piece: We have a lot of work to do in terms of the workforce, the data, the laboratory, the community outreach. Our health care system was overwhelmed in many places. The supply chain is very interdependent internationally. This was a really complex, systemwide assault.

But another threat tomorrow, we're not where we need to be. We're still battling this one. And we have a lot of work to do to get better prepared for the next one. But I think there's political will that might have been missing before.

As a disease detective, with the experience that you have, what have you thought about as people have raised more questions about the origins of the virus?

I want all the questions to be answered. There's so much we need to learn about this virus and this pandemic so that we do better next time and prevent where we can. ... Sometimes scientists have questions because they're kind of curious, and more is better. But I think there's a lot we really do need to know here. So understanding where this came from and how it spread so easily I think is important.

As you step away, how seriously do you take the possibility that this virus may have in some form originated in a lab in China?

We need to do the investigations. I think they're important.

You don't rule it out.

I don't think we have all the answers that we need, and so I support the idea of additional investigations and, you know, getting to the bottom of that.

Here is the original post:
The CDC's No. 2 Official Says The US Isn't Ready For Another Pandemic | NPR - Houston Public Media

Written by Nandni Mahajan, Edited by Explained Desk | New Delhi | June 6, 2021 5:23:28 pm

On June 6, Mexico will vote to elect deputies to its 500-seat lower house of Congress, governors in 15 states, and hundreds of mayors and local legislators more than 20,000 positions in all.

This electoral cycle has been one of the most violent in Mexico since 2000, with 89 political assassinations, over a hundred casualties, 782 acts of aggression, and an exponential rise in crime since September 2020, according to figures provided by Mexican consulting firm Etellekt.

Elections in Mexico have always been tainted by political violence the 2018 election recorded over 130 deaths of politicians and candidates along with reports of hundreds of casualties and crimes. Etellekt reported that criminal aggression in the 2021 round of elections is 64 per cent higher than recorded in 2018.

The perpetrators of this violence are Mexicos organised crime syndicates and drug cartels, who want to gain control over municipal governments, local economies and populations to dominate drug-trafficking routes and criminal activities in their territories.

In this political tussle, some politicians reject organised crime, while others seek support from gangs for their money and manpower. On one hand, political hopefuls have dropped out of races due to threat to their lives, on the other, criminal leaders have publicly declared support for some politicians.

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Who are the victims?

Majority of the victims are political hopefuls contesting for mayoral and local-level seats, which places them in a vulnerable position as crime groups seek to gain authority at the local level to increase territorial control.

In March alone, one politician was assassinated per day, many have been kidnapped, while some have even lost family members in these attacks.

Criminal organisations are more likely to attack and threaten politicians unprotected by the police or military. Also, politicians with grassroot campaigns to weed out crimes from their municipalities are at a much greater risk of threats. As many as 75 per cent of the attacks were against opposition politicians in areas where they were contesting.

Criminal violence is also used in retaliation against politicians/public servants who did not aid criminal gangs. Over 60 candidates for mayoral posts have withdrawn from campaigns due to threats and campaigning has been suspended in many areas due to rise in violence.

How and why are criminal gangs dominating the elections?

According to government estimates, nearly 200 criminal gangs operate in Mexico. These groups are highly sophisticated, organised, well-funded and have infiltrated every level of the Mexican society, including public institutions.

Drug cartels have now diversified into new criminal activities. According to Wall Street Journal, apart from drug trafficking, these groups smuggle migrants into the US, sell black-market gasoline, and extort money and resources from local businesses. Once in control of local governments, these gangs also take money meant for public works.

Many smaller groups are now viciously competing to control local areas by intimidating and killing off politicians, with these actions posing a direct threat to Mexicos young democracy.

Falko Ernst, a senior Mexico analyst for the International Crisis Group, told the Wall Street Journal, That hyper-competition has put government officials and candidates in greater danger.

Gema Kolppe-Santamaia, another Mexican crime investigator at Loyola University Chicago, told The Guardian, The point of gaining control over the next mayor is to assure that this mayor guarantees access to two prize resources: public money and the police.

Where are public institutions in all of this?

Mexicos judicial and policing systems are infamous for corruption and high impunity rates. In 2019, only 0.3 per cent of the recorded crimes saw prosecutors filing charges and the criminals being brought to trial in front of a judicial body.

In this election cycle, Mexican authorities have logged 398 attacks/threats on candidates, most of which are likely to remain unsolved.

Falko Ernst also told The Guardian, Criminal groups have learned their lesson over the past few years that no matter what they do including killing candidates or attacking public institutions there are no consequences. He further said that Mexican judicial institutions play no role in solving crime and prosecuting criminals.

While 150 candidates have received protection from the government, it nearly isnt enough. Some candidates who have been attacked have accused the national guard and police of not protecting them.

Mexicos President, Andres Manuel Lopez Obrador, has accused the media of sensationalising the assassinations and crimes to make the government look bad. He also declared that there is peace and tranquility throughout Mexico, despite overwhelming evidence to the contrary.

Analysts have said this wave of political aggression can be blamed on the Presidents security policy of eliminating what he calls the economic roots of violence by providing jobs for poor youth, instead of taking head-on action and bringing in the military and police to confront the countrys powerful cartels.

The government has no policy to contain these criminal organisations, Guillermo Valdes, a former head of Mexicos intelligence agency, told Wall Street Journal.

As reported by Mexico Daily News, the secretary of Mexicos Interior Minister, Olga Sanchez Cordero, said that the attacks against candidates are unrelated to the election. She said unions and student organisations are exploiting the present circumstances to violently air their demands.

Whats next?

With the high number of seats up for election, a new composition in the lower house could emerge, that could significantly shape the federal security policy. Even at the local level, leaders who are non-compliant with criminal gangs and cartels could possibly lead to the eventual decline of criminal activities.

Amidst the rising fears of violence on election day at polling stations, Lorenzo Cordova, the president of the National Electoral Institute (INE), said that the commission isnt responsible for providing security but the federal government is.

Excelsior reported that elections have already been cancelled in two municipalities due to rising security concerns. Cordova added that polling stations may not be installed in various other parts if the situation is not contained.

Continue reading here:
Explained: Why run-up to elections in Mexico this time is the most violent in 21 years - The Indian Express

Basel, June 4, 2021 Novartis today announced the first published mature overall survival (OS) and updated overall response rate (ORR) data following treatment with Tabrecta (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)1-3. Data from the ongoing, pivotal, multi-cohort Phase II GEOMETRY mono-1 study will be presented today during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Poster Discussion Session, Lung CancerNon-Small Cell Metastatic; June 4, 2021, 9:00 AM-10:00 AM CT; abstract 9020).

This new analysis further supports Tabrecta as a cornerstone targeted treatment for METex14 NSCLC patients and highlights the importance of biomarker testing, said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, and lead investigator of the GEOMETRY study. The impressive overall survival outcome and confirmed outstanding response in the first-line setting will help oncologists decide upon a therapeutic option for patients.

The analysis includes new data from the treatment-nave (1L) expansion cohort 7 and previously-treated (2L+) cohort 6, and mature data from previously-reported cohorts, for a total of 160 patients1,2.

The introduction of Tabrecta a year ago dramatically changed the treatment landscape for patients with METex14 NSCLC. Now we have further evidence that Tabrecta, the market-leading treatment specifically for METex14 NSCLC patients4, has the potential to help people live longer, said Jeff Legos, Senior Vice President, Head of Oncology Drug Development, Novartis Oncology.

The results presented today provide additional data on the efficacy of Tabrecta in both treatment-nave and previously-treated patients with METex14 metastatic NSCLC 2:

No new safety signals or unexpected safety findings were observed. Ninety-eight percent of subjects had at least one adverse event (AE) of any grade and 50.9% of subjects had at least one serious adverse event (SAE). Thirteen percent were suspected to be treatment-related. The most common adverse events (>20%, all grades) across all cohorts were peripheral edema, nausea, vomiting, increased blood creatinine, dyspnea, fatigue and decreased appetite. The majority of AEs were grade 3 or 42.

Currently, the five-year survival rate for lung cancer is less than 20%5, decreasing further when the disease is diagnosed at later stages6. Nearly one in three patients with metastatic NSCLC may have an actionable mutation7,8. METex14 has been reported to occur in 3%-4% of metastatic NSCLC cases9. Many patients with mutations that lead to METex14 are not diagnosed with NSCLC until their disease has progressed to later stages and often have poor prognosis10,11.

A separate analysis of patient-reported outcomes (PROs) evaluated cough, delayed time to lung symptom deterioration, and quality of life (QoL) in NSCLC patients with METex14 (abstract 9056)3.

Additionally, a retrospective analysis of GEOMETRY mono-1 validates the clinical utility of liquid biopsy testing to identify METex14 positivepatientsfor treatment withTabrecta (Poster Session: Lung CancerNon-Small Cell Metastatic; abstract 9111)12.

Visithttps://www.hcp.novartis.com/virtual-congress/a-2021/ for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO21 Virtual Scientific Program data presentations (for registered participants).

About GEOMETRY mono-1GEOMETRY mono-1 is a Phase II a multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, metastatic NSCLC harboring mutations that lead to MET exon-14 skipping who received capmatinib tablets 400 mg orally twice daily.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy13. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC.

About Tabrecta (capmatinib)Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. In May 2020, Tabrecta was approved by the US Food and Drug Administration (FDA) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

In June 2020, Tabrecta was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test.Tabrecta was also approved in Hong Kong in February 2021 and Switzerland in April 2021.

Novartis and Lung CancerLung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year14. There are two main types of lung cancer small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)15,16. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 2 million new cases each year14,16.More people die of lung cancer every year than any other cancer type14. Treatment options are limited for people with lung cancer who experience cancer growth or progression while on current standard of care treatments17-19.

Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer core immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. Novartis research activities are informed by our long-term relationships with leading lung cancer thought leaders and patient advocates. With them, Novartis is committed to reimagining the treatment of lung cancer.

IndicationTABRECTA (capmatinib) tablets is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery (metastatic), and whose tumors have an abnormal mesenchymal-epithelial transition (MET) gene.

The effectiveness of TABRECTA in these patients is based on a study that measured 2 types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with TABRECTA live longer or if their symptoms improve. There are ongoing studies to find out how TABRECTA works over a longer period of time.

It is not known if TABRECTA is safe and effective in children.

Important Safety InformationTABRECTA may cause serious side effects, such as lung or breathing problems. TABRECTA may cause inflammation of the lungs during treatment that may lead to death. Patients should be advised to contact their health care provider right away if they develop any new or worsening symptoms, including cough, fever, trouble breathing, or shortness of breath.

TABRECTA may cause abnormal blood test results, which may be a sign of liver problems. Patients should be advised that their health care provider will do blood tests to check their liver before starting and during treatment with TABRECTA. Patients should be advised to contact their health care provider right away if they develop any signs and symptoms of liver problems including the skin or the white part of their eyes turning yellow (jaundice), dark or tea-colored urine, light-colored stools (bowel movements), confusion, loss of appetite for several days or longer, nausea and vomiting, pain, aching, or tenderness on the right side of the stomach area (abdomen), or weakness or swelling in the stomach area.

The skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Patients should be advised to use sunscreen or wear clothes that cover their skin during treatment with TABRECTA to limit direct sunlight exposure.

For women of reproductive potential, TABRECTA can harm their unborn baby. They should use an effective method of birth control during treatment with TABRECTA and for 1 week after the last dose. Men who have partners who can become pregnant should use effective birth control during treatment with TABRECTA and for 1 week after the last dose.

Before taking TABRECTA, patients should tell their health care provider about all their medical conditions, including if they have or have had lung or breathing problems other than lung cancer, have or have had liver problems, or if they are pregnant or plan to become pregnant, as TABRECTA can harm their unborn babies. Females who are able to become pregnant should have a pregnancy test before they start treatment with TABRECTA and should use effective birth control during treatment and for 1 week after the last dose of TABRECTA. Patients should be advised to talk to their health care provider about birth control choices that might be right for them during this time and to tell their health care provider right away if they become pregnant or think they may be pregnant during treatment with TABRECTA. Males who have female partners who can become pregnant should use effective birth control during treatment and for 1 week after their last dose of TABRECTA.

Patients should tell their health care provider about all the medicines they take or start taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of TABRECTA include swollen hands, ankles, or feet (peripheral edema); nausea and/or vomiting; tiredness and/or weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of appetite; changes in bowel movements (diarrhea or constipation); cough; pain in the chest; fever (pyrexia); back pain; and decreased weight.

Please see full Prescribing Information for Tabrecta available athttps://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com/.

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References

*FoundationOneCDx is a registered trademark of Foundation Medicine, Inc.

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Excerpt from:
Novartis announces Tabrecta first published overall survival and updated overall response data in patients with METex14 - GlobeNewswire