FRANKFURT: Novartis breast cancer drug Kisqali cut the risk of recurrence by more than 25 percent in a pivotal trial on women diagnosed at an early stage, positioning the Swiss drugmaker to win new patients and but facing strong competition from Eli Lilly.
The company on Friday said the relative risk reduction of cancer recurrence was 25.2 percent and that the results were broadly consistent regardless of patients’ menopausal status or cancer progression status. The results were presented at the annual meeting of the American Society of Clinical Oncology in Chicago.
The Swiss drugmaker’s shares rose, even as the efficacy read-out fell short of that of a drug by Lilly, but a more favorable side effect profile might swing the balance in favor of Kisqali.
The drug was used in the trial together with standard endocrine therapy to treat a type of cancer that grows in response to hormones and it was compared to endocrine therapy alone.
The Novartis treatment has been approved to treat hormone-driven breast cancer that has spread to other parts of the body, where Novartis has taken market share from Pfizer’s Ibrance.
But an earlier diagnosis, when tumors can still be surgically removed, is much more common, representing about 90 percent of patients.
Still, better drugs are needed after surgery because the cancer later returns in between a third and one half of cases.
Eli Lilly is ahead with the approval of rival drug Verzenio in the early setting. But that is in a subset of women who are at high risk of recurrence after surgery, typically diagnosed based on signs of cancer in the lymph nodes.
Here, Novartis will face tough competition because the US drugmaker has said Verzenio reduces the risk of recurrence by 35 percent in that group.
But Kisqali looks set to be a pioneer in a wider market because it was tested successfully in both high-risk and medium-risk patients, a population that is twice as large.
Analysts have said investors could be disappointed if the Kisqali read-out fell well short of Verzenio’s efficacy and Jefferies analysts said on Friday the efficacy read-out was “closer to our downside scenario.”
But Novartis stressed very low rates of symptomatic side effects in its trial, important to patients facing years-long treatment, with severe diarrhea affecting only 0.6 percent of participants on Kisqali.
That compares with 8 percent-20 percent of the women in trials with Eli Lilly’s Verzenio being affected by severe diarrhea.
“This may be very relevant commercially,” said Evercore ISI analyst Umer Raffat.
Novartis shares were up 1.5 percent at 1430 GMT, rebounding from initial losses after the news. Lilly shares gained 0.9 percent.
“We know diarrhea can be a very troublesome, burdensome adverse event for patients taking anti-cancer medicines,” said Jeff Legos, Head of Oncology & Hematology Development at Novartis.
The March trial update boosted market confidence in targets issued by CEO Vas Narasimhan for annual sales growth of 4 percent through 2027 and a core operating income margin of 40 percent from 2027, analysts have said.
Novartis will request approval for wider use in the US and Europe before the end of the year, it added.
Novartis gave a brief preview of the Kisqali data in March, boosting its shares and growth prospects.
Novartis drug cuts recurrence risk by 25% in early-stage breast cancer
https://arab.news/8b9e8
Novartis drug cuts recurrence risk by 25% in early-stage breast cancer
- The company on Friday said the relative risk reduction of cancer recurrence was 25.2%
- The results were broadly consistent regardless of patients' menopausal status or cancer progression status
Wildfires force mandatory evacuation order in western North Carolina
- The North Carolina Forest Service’s online wildire public viewer indicated three active fires in Polk County and two others in nearby Burke and Madison
The North Carolina Department of Public Safety announced a mandatory evacuation starting at 8:20 p.m. Saturday for parts of Polk County in western North Carolina about 80 miles (128.7 kilometers) west of Charlotte.
“Visibility in area will be reduced and roads/evacuation routes can become blocked; if you do not leave now, you could be trapped, injured, or killed,” a social media post by the agency warned residents of specific roads.
The public safety department said a shelter had been established in Columbus, North Carolina.
The North Carolina Forest Service’s online wildire public viewer indicated three active fires in Polk County and two others in nearby Burke and Madison counties, with another wildfire burning in Stokes County on the northern border with Virginia.
North Carolina’s western region was hit hard by Hurricane Helene in September. Among the extensive damage, flooding washed away more than a mile (1.6 kilometers) of eastbound lanes on Interstate 40 leading to eastern Tennessee and remained partially closed to traffic until March.
The hurricane damaged or impacted 5,000 miles (8,046 kilometers) of state-maintained roads and damaged 7,000 private roads, bridges and culverts in North Carolina.
Canada’s new PM Carney will run in Ottawa area district as he seeks to join Parliament
- Carney, sworn in as Canada’s 24th prime minister on March 14, said the government in a time of crisis needs a strong and clear mandate
- The governing Liberals had appeared poised for a historic election defeat this year until Trump declared a trade war
TORONTO: New Canadian Prime Minister Mark Carney will run in an Ottawa area district as he seeks to join Parliament for the first time, the Liberal Party announced Saturday, a day before Carney triggers an early general election before a vote on April 28.
The election will take place against the backdrop of a trade war and sovereignty threats from US President Donald Trump.
The Liberal Party said Carney will run to represent the suburban Ottawa area of Nepean, noting in a social media post that Ottawa is where he raised his family and devoted his career to public service. He previously served as the head of Canada’s central bank and before that its deputy.
The election campaign for 343 seats or districts in the House of Commons will last 37 days.
The party that commands a majority in the House of Commons, either alone or with the support of another party, will form the next government and its leader will be prime minister.
Carney replaced Justin Trudeau, who announced his resignation in January, but remained in power until the Liberal Party elected a new leader on March 9 following a leadership race by the governing party.
Carney, sworn in as Canada’s 24th prime minister on March 14, has said the government in a time of crisis needs a strong and clear mandate.
The governing Liberals had appeared poised for a historic election defeat this year until Trump declared a trade war. Trump has repeatedly said that Canada should become the 51st US state and he acknowledged Friday that he has upended Canadian politics.
What Trump hasn’t said is that the almost daily attacks on Canada’s sovereignty have infuriated Canadians. That has led to a surge in Canadian nationalism that has bolstered Liberal poll numbers.
The opposition Conservatives hoped to make the election about Trudeau, whose popularity declined as food and housing prices rose and immigration surged. But after decades of bilateral stability, the vote is now is expected to focus on who is best equipped to deal with Trump.
Trump put 25 percent tariffs on Canada’s steel and aluminum and is threatening sweeping tariffs on all Canadian products — as well as all of America’s trading partners — on April 2.
Carney still hasn’t had a phone call with Trump and that might not happen now until after the election. Trump mocked Trudeau by calling him governor, but he has not yet mentioned Carney’s name.
Carney, 60, was the head of the Bank of Canada during the 2008 financial crisis. In 2013, he became the first noncitizen of the United Kingdom to run the Bank of England — helping to manage the impact of Brexit.
Pierre Poilievre, the leader of the Conservatives, is Carney’s main challenger. The party and Poilievre were heading for a huge victory in Canada’s federal election this year until Trump’s near-daily trade and annexation threats derailed them.
Poilievre, 45, for years the party’s go-to attack dog, is a career politician and firebrand populist who says he will put “Canada first.” He attacks the mainstream media and vows to defund Canada’s public broadcaster. His party announced that it won’t allow media onboard his campaign buses and planes.
Chinese to pursue ‘correct’ path of globalization
- “China will firmly stand on the correct side of history, that of fairness and justice," Premier Li Qiang tells global business executives
- The China Development Forum convenes amid a renewed trade war with the US under Trump threatening China’s booming exports
BEIJING: China’s number two leader told a gathering of business executives in Beijing on Sunday that the country would “adhere to the correct direction of economic globalization” in the face of “fragmentation.”
The China Development Forum convenes amid a renewed trade war with Washington, with the return of Donald Trump to the White House threatening China’s booming exports.
Beijing has been seeking to steer a shaky economy onto a more stable path since the end of the pandemic, particularly by boosting consumption.
“China will firmly stand on the correct side of history, that of fairness and justice, and act in a righteous manner amid the rough waters of the times,” Premier Li Qiang told the Chinese officials and global business executives.
China will “adhere to the correct direction of economic globalization, practice true multilateralism and strive to be a force for stability and certainty,” he added.
The Chinese premier said that “today, global economic fragmentation is intensifying,” adding that “instability and uncertainty are on the rise.”
Li’s speech came at the opening of the annual China Development Forum, attended this year by prominent business leaders including Apple CEO Tim Cook.
The Pentagon’s DEI purge: Officials describe a scramble to remove and then restore online content
- Overall, tens of thousands of online posts that randomly mention dozens of key words, including “gay,” “bias” and “female” — have been delete
- Overall, tens of thousands of online posts that randomly mention dozens of key words, including “gay,” “bias” and “female” — have been deleted
WASHINGTON: Every day over the past few weeks, the Pentagon has faced questions from angry lawmakers, local leaders and citizens over the removal of military heroes and historic mentions from Defense Department websites and social media pages after it purged online content that promoted women or minorities.
In response, the department has scrambled to restore a handful of those posts as their removals have come to light. While the pages of some well-known veterans, including baseball and civil rights icon Jackie Robinson, are now back up on Pentagon websites, officials warn that many posts tagged for removal in error may be gone forever.
The restoration process has been so hit or miss that even groups that the administration has said are protected, like the Tuskegee Airmen, the first Black military pilots who served in a segregated World War II unit, still have deleted pages that as of Saturday had not been restored.
This past week chief, Pentagon spokesman Sean Parnell said in a video that mistaken removals will be quickly rectified. “History is not DEI,” he said, referring to diversity, equity and inclusion.
But due to the enormous size of the military and the wide range of commands, units and bases, there has been an array of interpretations of what to remove and how as part of the Pentagon directive to delete online content that promotes DEI. Officials from across the military services said they have asked for additional guidance from the Pentagon on what should be restored, but have yet to receive any.
The officials, who spoke to The Associated Press on condition of anonymity to describe internal deliberations, said, for example, they were waiting for guidance on whether military “firsts” count as history that can be restored. The first female Army Reserve graduate of Ranger School, Maj. Lisa Jaster, or the first female fighter pilot, Air Force Maj. Gen. Jeannie Leavitt, both had their stories deleted.
Some officials said their understanding was it did not matter whether it was a historic first. If the first was based on what Defense Secretary Pete Hegseth found to be a disqualifying characteristic, such as gender or race, it had to go, they said.
One Army team has taken a very deliberate approach.
According to the officials, the team took down several major historical heritage sites that had many postings about women and various ethnic or racial groups. They are now going through them all and plan to rework and repost as much as possible on a new website focused on Army heroes. The process, the officials said, could take months.
Overall, tens of thousands of online posts that randomly mention dozens of key words, including “gay,” “bias” and “female” — have been deleted. Officials warn that the bulk of those images are gone for good. Even as complaints roll in, officials will be careful about restoring things unless senior leaders approve.
The officials described the behind-the-scenes process as challenging, frustrating and emotionally draining. Workers going through years of posts to take down mentions of historic accomplishments by women or minorities were at times reduced to tears or lashed out in anger at commanders directing the duty, the officials said.
Others were forced to pull down stories they were proud of and had worked on themselves. They were often confused about the parameters for removal once a key word was found, and they erred on the side of removal, according to the officials.
Not complying fully with the order was seen as dangerous because it could put senior military service leaders at risk of being fired or disciplined if an errant post celebrating diversity was left up and found. Officials said the department relied in large part on a blind approach — using artificial intelligence computer commands to search for dozens of those key words in online department, military and command websites.
If a story or photo depicted or included one of the terms, the computer program then added “DEI” into the web address of the content, which flagged it and led to its removal.
Purging posts from X, Facebook and other social media sites is more complicated and time intensive. An AI command would not work as well on those sites.
So military service members and civilians have evaluated social media posts by hand, working late into the night and on weekends to pore over their unit’s social media pages, cataloging and deleting references going back years. Because some civilians were not allowed to work on weekends, military troops had to be called in to replace them, as the officials described it.
The Defense Department is publicly insisting that mistakes will be corrected.
As an example, the Pentagon on Wednesday restored some pages highlighting the crucial wartime contributions of Navajo Code Talkers and other Native American veterans. That step came days after tribes condemned the removal. Department officials said the Navajo Code Talker material was erroneously erased,
The previous week, pages honoring a Black Medal of Honor winner and Japanese American service members were also restored.
The restorations represent a shift from early, adamant denials that any deletion of things such as the Enola Gay or prominent service members was happening at all. At least two images of the Enola Gay, the plane that dropped the first atomic bomb on Hiroshima, Japan, during World War II, are still missing.
“This is fake news and anyone with a pulse knows it!” the Defense Department’s new “Rapid Response” social media account asserted March 7. “We are NOT removing images of the Enola Gay or any other pictures that honor the legacy of our warfighters.”
Over time, the Pentagon has shifted its public response as more examples of deleted pages came to light.
On Thursday, Parnell acknowledged in a video posted online that: “Because of the realities of AI tools and other software, some important content was incorrectly pulled off line to be reviewed. We want to be very, very clear: History is not DEI. When content is either mistakenly removed, or if it’s maliciously removed, we continue to work quickly to restore it.”
But others have seen the widespread erasure of history.
“Most female aviator stories and photographs are disappearing— including from the archives. From the WASPs to fighter pilots, @AFThunderbirds to @BlueAngels — they’ve erased us,” Carey Lohrenz, one of the Navy’s first female F-14 Tomcat pilots, posted to X. “It’s an across the board devastating loss of history and information.” Among the webpages removed include one about the Women Air Service Pilots, or WASPs, the female World War II pilots who were vital in ferrying warplanes for the military, and the Air Force Thunderbirds.
Parnell, Hegseth and others have vigorously defended the sweeping purge despite the flaws.
“I think the president and the secretary have been very clear on this — that anybody that says in the Department of Defense that diversity is our strength is, is frankly, incorrect,” Parnell said during a Pentagon media briefing. “Our shared purpose and unity are our strength.”
After breaking fast, volunteers use Ramadan as an opportunity to give in Detroit
- Daoud said the group’s efforts are emblematic of Islam’s emphasis on respecting and valuing resources such as food and matches Ramadan’s focus on “self-discipline and empathy toward those less fortunate”
DEARBORN, Michigan: After a nightly iftar meal with family members breaking fast together during Ramadan, Nadine Daoud noticed full pots and trays of untouched leftover food lining the shelves of her grandmother’s refrigerator. Too often, she felt the food was quickly forgotten and then wasted.
The observations inspired her 2017 creation of The Helping Handzzz Foundation that brings volunteers together each year during the Islamic holy month. They round up spare food from families in Dearborn — where nearly half the 110,000 residents are of Arab descent — and bring it to people without homes in neighboring Detroit.
Daoud said the group’s efforts are emblematic of Islam’s emphasis on respecting and valuing resources such as food and matches Ramadan’s focus on “self-discipline and empathy toward those less fortunate.”
“Every family cooks a lot of food to end the night when you’re breaking your fast,” Daoud said. “And a lot of food gets left over. And we noticed that a lot of this food was just getting stored in the fridge and forgotten about the next day.
“What I decided to do was instead of sticking it in the fridge and forgetting about it or throwing it in the trash, I said, ‘Let me take it. I always see people on the corners. Let me help out and give it to them instead with a drink and a nice treat on the side.’“
One recent night, Helping Handzzz board members Hussein Sareini and Daoud Wehbi and four others enjoyed an iftar prepared by Sareini’s mother.
When the meal ended, several attendees said some of the daily prayers. Then, Wehbi hopped in Sareini’s truck, and they stopped at several area homes to pick up untouched dishes. From there, they drove to the parking lot of a nearby mosque, where Nadine Daoud and others organized the food.
A caravan of vehicles then visited several spots in Detroit where people without housing regularly can be found.
Board member Mariam Hachem approached a man bundled up in blankets and lying on the sidewalk.
“Hi, we have a meal for you,” she said. “We’re going to set it right here, OK?”
“OK,” came the response.
Other volunteers added bottled water and a sweet treat alongside the food container.
The Helping Handzzz team goes through the same process six nights each week during the sacred month, taking off Sundays. And it comes after going without food or water from sunrise to sunset.
Wehbi, 27, is a design engineer at Toyota. Sareini demolishes bathrooms and kitchens and rebuilds them as part of his residential remodeling business.
The 25-year-old Dearborn resident said he gladly stays out until 9 p.m. or 10 p.m. each day to put some “good out into the world.”
“It’s all about appreciating what you have,” he said.
Wehbi said it’s no coincidence he and his friends undertake their annual effort during Ramadan.
“It’s not just a ‘no food, no drink’ time,” he said. “It’s a lot about growing and coming together as a community and bettering ourselves and bettering each other.”
