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
US judge orders release of pro-Palestinian protest leader
Khalil, a legal permanent US resident who is married to a US citizen and has a US-born son, has been in custody since March facing potential deportation.
District Judge Michael Farbiarz ordered Khalil’s release on bail during a hearing on Friday and he will be allowed to return to New York while his deportation case proceeds.
“After more than three months, we can finally breathe a sigh of relief and know that Mahmoud is on his way home,” his wife, Michigan-born dentist Noor Abdalla, said in a statement.
“We know this ruling does not begin to address the injustices the Trump administration has brought upon our family and so many others the government is trying to silence for speaking out against Israel’s ongoing genocide against Palestinians,” added Abdalla, who gave birth to the couple’s first child while her husband was in detention.
Amol Sinha, executive director of the American Civil Liberties Union of New Jersey, which is among the groups representing Khalil, welcomed the release order.
“This is an important step in vindicating Mr.Khalil’s rights as he continues to be unlawfully targeted by the federal government for his advocacy in support of Palestinian rights,” Sinha said. “We’re confident he will ultimately prevail in the fight for his freedom.”
Since his March 8 arrest by Immigration and Customs Enforcement agents, Khalil has become a symbol of President Donald Trump’s campaign to stifle pro-Palestinian student activism against the Gaza war, in the name of curbing anti-Semitism.
At the time a graduate student at Columbia University in New York, Khalil was one of the most visible leaders of nationwide campus protests against Israel’s war in Gaza.
Following his arrest, US authorities transferred Khalil, who was born in Syria to Palestinian parents, nearly 2,000 kilometers (1,242 miles) from his home in New York to a detention center in Louisiana, pending deportation.
Secretary of State Marco Rubio has invoked a law approved during the 1950s Red Scare that allows the United States to remove foreigners seen as adverse to US foreign policy.
Rubio argues that US constitutional protections of free speech do not apply to foreigners and that he alone can make decisions without judicial review.
Hundreds of students have seen their visas revoked, with some saying they were targeted for everything from writing opinion articles to minor arrest records.
Farbiarz ruled last week that the government could not detain or deport Khalil based on Rubio’s assertions that his presence on US soil poses a national security threat.
The government has also alleged as grounds to detain and deport Khalil that there were inaccuracies in his application for permanent residency.
Violence against children hit ‘unprecedented levels in 2024’
- The UN kept Israeli forces on its blacklist of countries that violate children’s rights for a second year, citing 7,188 verified grave violations by its military, including the killing of 1,259 Palestinian children and injury to 941 others in Gaza
- UN chief cites warfare strategies that included deployment of destructive and explosive weapons
NEW YORK: Violence against children caught in multiple and escalating conflicts reached “unprecedented levels” last year, with the highest number of violations in Gaza and the West Bank, Congo, Somalia, Nigeria and Haiti, according to a UN report.
Secretary-General Antonio Guterres’ annual report on Children in Armed Conflict detailed “a staggering 25 percent surge in grave violations” against children under the age of 18 from 2023, when the number of such violations rose by 21 percent.
In 2024, the UN chief said children “bore the brunt of relentless hostilities and indiscriminate attacks, and were affected by the disregard for ceasefires and peace agreements and by deepening humanitarian crises.”
FASTFACT
UN Secretary-General Antonio Guterres said he is ‘appalled by the intensity of grave violations against children in the occupied Palestinian territories and Israel,’ and ‘deeply alarmed’by the increase in violations, especially the high number of children killed by Israeli forces.
He cited warfare strategies that included attacks on children, the deployment of increasingly destructive and explosive weapons in populated areas, and “the systematic exploitation of children for combat.”
Guterres said the UN verified 41,370 grave violations against children — 36,221 committed in 2024 and 5,149 committed earlier but verified last year.
The violations include killing, maiming, recruiting and abducting children, sexual violence against them, attacking schools and hospitals, and denying youngsters access to humanitarian aid.
The UN kept Israeli forces on its blacklist of countries that violate children’s rights for a second year, citing 7,188 verified grave violations by its military, including the killing of 1,259 Palestinian children and injury to 941 others in Gaza.
The Gaza Health Ministry has reported much higher figures, but the UN has strict criteria and said its process of verification is ongoing.
Guterres said he is “appalled by the intensity of grave violations against children in the occupied Palestinian territories and Israel,” and “deeply alarmed” by the increase in violations, especially the high number of children killed by Israeli forces.
He reiterated his calls on Israel to abide by international law requiring special protections for children, protection for schools and hospitals, and compliance with the requirement that attacks distinguish between combatants and civilians and avoid excessive harm to civilians.
The UN also kept Hamas and Palestinian Islamic Jihad on the blacklist.
Israel’s UN Mission did not immediately respond to a request for comment.
In Congo, the UN reported 4,043 verified grave violations against 3,418 children last year.
In Somalia, it reported 2,568 violations against 1,992 children.
In Nigeria, 2,436 grave violations were reported against 1,037 children. And in Haiti, the UN reported 2,269 verified grave violations against 1,373 children.
In the ongoing war following Russia’s February 2022 invasion of Ukraine, the UN kept the Russian armed forces and affiliated armed groups on its blacklist for a third year. The secretary-general expressed deep concern at “the sharp increase in grave violations against children in Ukraine” — 1,914 against 673 children.
He expressed alarm at the violations by Russian forces and their affiliates, singling out their verified killing of 94 Ukrainian children, injury to 577 others, and 559 attacks on schools and 303 on hospitals.
In Haiti, the UN put a gang, the Viv Ansanm coalition, on the blacklist for the first time.
Gangs have grown in power since the assassination of President Jovenel Moise in July 2021.
They are estimated to control 85 percent of the capital and have moved into surrounding areas.
In May, the US designated the powerful coalition representing more than a dozen gangs, whose name means “Living Together,” as a foreign terrorist organization.
Secretary-General Guterres expressed deep “alarm” at the surge in violations, especially incidents of gang recruitment and use, sexual violence, abduction, and denial of humanitarian aid.
The report said sexual violence jumped by 35 percent in 2024, including a dramatic increase in the number of gang rapes, but stressed that the numbers are vastly underreported.
“Girls were abducted for the purpose of recruitment and use, and for sexual slavery,” the UN chief said. In Haiti, the UN reported sexual violence against 566 children, 523 of them girls, and attributed 411 to the Viv Ansanm gang.
In Congo, the UN reported 358 acts of sexual violence against girls — 311 by armed groups and 47 by Congo’s armed forces. And in Somalia, 267 children were victims of sexual violence, 120 of them carried out by Al-Shabab extremists.
According to the report, violations affected 22,495 children in 2024, with armed groups responsible for almost 50 percent and government forces the main perpetrator of the killing and maiming of children, school attacks, and denial of humanitarian access.
The report noted a sharp rise in the number of children subjected to multiple violations — from 2,684 in 2023 to 3,137 in 2024.
“The cries of 22,495 innocent children who should be learning to read or play ball — but instead have been forced to learn how to survive gunfire and bombings — should keep all of us awake at night,” said Virginia Gamba, the UN special representative for children and armed conflict.
“We are at the point of no return,” she said, calling on the international community to protect children and the parties in conflict “to immediately end the war on children.”
Italy grapples with mass exodus and foreign influx amid economic fears
- Ukrainians made up the biggest national group among those who arrived in 2023-2024, Istat said, followed by Albanians, Bangladeshis, Moroccans, Romanians, Egyptians, Pakistanis, Argentines, and Tunisians
ROME: The number of Italians leaving their country and foreigners moving in has soared to the highest in a decade, official data showed on Friday, fueling national concerns about brain drain, economic decline, and immigration.
Italy has a right-wing government elected in 2022 on a mandate to curb migrant arrivals, but also has a shrinking population and growing labor shortages, highlighting the need to attract foreign workers.
Meanwhile, the country’s stagnant economy and low wages — salaries are below 1990 levels in inflation-adjusted terms — have been blamed for pushing many Italians to seek better fortunes abroad.
FASTFACT
Ukrainians made up the biggest national group among those who arrived in 2023-2024, followed by Albanians, Bangladeshis, Moroccans, Romanians, Egyptians, Pakistanis, Argentines, and Tunisians.
Last year, 382,071 foreigners moved to Italy, up from 378,372 in 2023 and the highest since 2014, the statistics agency Istat said.
In the same period, 155,732 Italians emigrated, up from 114,057 in 2023 and also the highest since 2014. The immigration figure beat the previous high for the last decade of 301,000 in 2017, and was well above that period’s low of 191,766 from 2020 — the height of the COVID pandemic.
The figure of almost 270,000 nationals emigrating in the two-year period from 2023 to 2024 was up around 40 percent compared to the previous two years.
The two-year immigration figure for that period, around 760,000, was up 31 percent from 2021-2022.
The figures are derived from town registry offices, so are unlikely to reflect undocumented migration.
Ukrainians made up the biggest national group among those who arrived in 2023-2024, Istat said, followed by Albanians, Bangladeshis, Moroccans, Romanians, Egyptians, Pakistanis, Argentines, and Tunisians.
As for the high number of emigrants, “it is more than plausible” that a significant number were “former immigrants” who moved abroad after acquiring Italian citizenship, Istat said.
The agency also said Italy’s poorer south was continuing to depopulate, noting that almost 1 percent of residents in Calabria, the region with the lowest per capita income, moved to central or northern areas during 2023-2024.
Russia might try to take Ukrainian city of Sumy, Putin says
- Ukraine said Putin’s comments showed “disdain” for the peace process
- “We have no objective to take Sumy, but in principle I do not rule it out... They pose a constant threat to us, constantly shelling the border areas,” Putin said
SAINT PETERSBURG: Russian President Vladimir Putin said Friday he did not “rule out” his forces attempting to seize the northeastern Ukrainian city of Sumy, casting fresh doubt over the prospect of peace talks between Moscow and Kyiv.
Ukraine said Putin’s comments showed “disdain” for the peace process.
Diplomatic efforts to end the three-year conflict have stalled in recent weeks and Kyiv has accused Moscow of deliberately sabotaging a peace deal to prolong its full-scale offensive on the country.
Russia currently occupies around a fifth of Ukraine and has claimed four Ukrainian regions as its own since launching its assault in 2022, in addition to Crimea, which it captured in 2014.
The Sumy region is not one of the regions Moscow has formally annexed, although Russian forces have recently made inroads there for the first time in three years.
At Russia’s flagship economic forum in Saint Petersburg, Putin suggested Moscow could take Sumy as part of the creation of a “buffer zone” along the border and repeated his denial of Ukrainian statehood.
“We have no objective to take Sumy, but in principle I do not rule it out... They pose a constant threat to us, constantly shelling the border areas,” Putin said.
“I consider Russians and Ukrainians to be one people. In that sense, all of Ukraine is ours,” he told attendees, when asked why his army was entering areas Moscow did not claim as its own.
“There is a saying: wherever a Russian soldier sets foot, that is ours.”
Ukrainian Foreign Minister Andriy Sybiga described Putin’s comments as “deranged” and called for Kyiv’s allies to slap “devastating sanctions” on Russia.
“The only way to force Russia into peace is to deprive it of its sense of impunity,” he wrote in a post on X.
Putin’s widening territorial ambitions are likely to roil Ukrainian President Volodymyr Zelensky,
who has accused Moscow of not wanting to end the fighting.
The two sides held rounds of direct talks in Istanbul in May and in June, but Kyiv accused Moscow of sending “dummy” negotiators with no real power to enact a peace deal.
Putin has declined to take part in the peace talks in person and on Thursday said he would only meet Zelensky during a “final phase” of negotiations on ending the three-year conflict.
He has also insisted Ukraine give up territory it already controls for peace.
Kyiv says it cannot and will not accept Russian occupation of any part of its land.
In his address Friday, Putin denied he was calling for Ukraine to “capitulate.”
“We are not seeking Ukraine’s surrender. We insist on recognition of the realities that have developed on the ground,” the Russian leader said.
Putin repeated that Moscow was “advancing on all fronts” and that his troops had penetrated up to 12 kilometers (seven miles) into the Sumy region.
He also accused Kyiv of “stupidity” by launching an incursion into Russia’s Kursk region last August.
“They are creating problems for themselves,” he said.
Russia has for months been rejecting calls for an unconditional ceasefire, launching deadly attacks on its neighbor.
Europeans’ meeting with top Iranian diplomat yields hope of more talks, no obvious breakthrough
- It was the first face-to-face meeting between Western and Iranian officials since the start of the conflict
- “The good result today is that we leave the room with the impression that the Iranian side is fundamentally ready to continue talking,” Wadephul said
GENEVA: A meeting between Iran’s foreign minister and top European diplomats on Friday yielded hopes of further talks but no indication of any immediate concrete breakthrough, a week after the crisis centered on the Iranian nuclear program erupted into war between Israel and Tehran.
Foreign ministers from Britain, France and Germany, as well as the European Union’s foreign policy chief, emerged from talks at a Geneva hotel about 3 1/2 hours after Iran’s Abbas Araghchi arrived for the meeting.
It was the first face-to-face meeting between Western and Iranian officials since the start of the conflict.
“The good result today is that we leave the room with the impression that the Iranian side is fundamentally ready to continue talking about all important issues,” German Foreign Minister Johann Wadephul said. He said the two sides had held “very serious talks.”
British Foreign Secretary David Lammy said: “We are keen to continue ongoing discussions and negotiations with Iran, and we urge Iran to continue their talks with the United States.” He added that “we were clear: Iran cannot have a nuclear weapon.”
“Military operations can slow Iran’s nuclear program but in no way can they eliminate it, said French Foreign Minister Jean-Noël Barrot. “We know well — after having seen what happened in Afghanistan, in Iraq, in Libya — how illusory and dangerous it is to want to impose regime change from outside.”
Barrot also said that European nations ”invited the Iranian minister to envisage negotiations with all parties including the United States, and without waiting for the end of the strikes.”
The French Foreign Minister explained that in discussions with Iran, Foreign Minister Araghchi agreed “to put all the issues on the table including some that weren’t there before” and “showed his disposition to continuing the conversation — that we started today — and for the Europeans to help facilitate, including with the United States.”
EU foreign policy chief Kaja Kallas said ”we agreed that we will discuss nuclear but also broader issues that we have, and keep the discussions open.”
Iran’s Foreign Minister Abbas Araghchi also addressed reporters outside the meeting venue after the talks ended. He expressed support for “a continuation of discussions with the E3 and the EU and expressed his readiness to meet again in the near future.” He also denounced Israel’s attacks against nuclear facilities in Iran and expressed “grave concern” on what he called “non-condemnation” by European nations.
US considering how to proceed
Lammy traveled to Geneva after meeting in Washington with US Secretary of State Marco Rubio and President Donald Trump’s Mideast envoy, Steve Witkoff.
Trump has been weighing whether to attack Iran by striking its well-defended Fordo uranium enrichment facility, which is buried under a mountain and widely considered to be out of reach of all but America’s “bunker-buster” bombs. He said Wednesday that he’ll decide within two weeks whether the US military will get directly involved in the war given the “substantial chance” for renewed negotiations over Tehran’s nuclear program.
Israel says it launched its airstrike campaign to stop Iran from getting closer to being able to build a nuclear weapon. Iran and the United States had been negotiating over the possibility of a new diplomatic deal over Tehran’s program, though Trump has said Israel’s campaign came after a 60-day window he set for the talks.
French Foreign Minister Jean-Noël Barrot said that “we wanted to open a discussion with the Iranian foreign minister because we believe that there is no definitive solution by military means to the Iranian nuclear problem — military operations may delay it but they can’t eliminate it.”
