Novartis drug cuts recurrence risk by 25% in early-stage breast cancer

Novartis breast cancer drug Kisqali cut the risk of recurrence by more than 25% in a pivotal trial on women diagnosed at an early stage. (AFP/File)
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Updated 03 June 2023
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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

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.


Putin must stop ‘unnecessary demands’ that prolong war, Zelensky tells EU

Updated 6 sec ago
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Putin must stop ‘unnecessary demands’ that prolong war, Zelensky tells EU

“Sanctions must remain in place until Russia starts withdrawing from our land,” he said

BRUSSELS: Ukraine President Volodymyr Zelensky said Moscow must stop making “unnecessary demands” that extend the war, calling for sanctions on Russia to remain in place until it begins pulling out of Ukrainian territory.
“Putin must stop making unnecessary demands that only prolong the war and must start fulfilling what he promises the world,” he told EU leaders by video call, according to an official transcript.
“Sanctions must remain in place until Russia starts withdrawing from our land and fully compensates for the damage caused by its aggression.”

UK PM Starmer: We must be ready to react quickly if Ukraine peace deal struck

Updated 8 min 45 sec ago
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UK PM Starmer: We must be ready to react quickly if Ukraine peace deal struck

  • “(Our) plans are focusing on keeping the sky safe, the sea safe and the border safe and secure in Ukraine,” Starmer said

LONDON: British Prime Minister Keir Starmer said on Thursday it was important Britain and its allies were able to react immediately should there be a peace deal struck between Russia and Ukraine.
His comments, made during a visit to a nuclear submarine facility, come on the day military chiefs from dozens of countries meet in Britain to discuss planning for a possible peacekeeping force in Ukraine.
“(Our) plans are focusing on keeping the sky safe, the sea safe and the border safe and secure in Ukraine, and working with the Ukrainians,” Starmer told reporters.
“We’re working at pace because we don’t know if there’ll be a deal. I certainly hope there will be, but if there’s a deal, it’s really important that we’re able to react straight away.”


Georgetown University scholar has been detained by immigration officials, prompting legal fight

Updated 48 min 15 sec ago
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Georgetown University scholar has been detained by immigration officials, prompting legal fight

  • Badar Khan Suri, a postdoctoral scholar at Georgetown University, was accused of “spreading Hamas propaganda and promoting antisemitism on social media”
  • The deportation effort comes amid legal fights over cases involving a Columbia University international affairs graduate student and a doctor from Lebanon

VIRGINIA: A Georgetown University researcher has been detained by immigration officials, prompting another high-profile legal fight over deportation proceedings against foreign-born visa holders who live in the US
Badar Khan Suri, a postdoctoral scholar at Georgetown University, was accused of “spreading Hamas propaganda and promoting antisemitism on social media” and determined to be deportable by the Secretary of State’s office, Homeland Security Assistant Secretary Tricia McLaughlin said late Wednesday on X, formerly known as Twitter.
The deportation effort comes amid legal fights over cases involving a Columbia University international affairs graduate student and a doctor from Lebanon.


Politico, which first reported on Suri’s case, said that masked agents arrested him outside his home in Arlington, Virginia, on Monday night and told him his visa had been revoked, citing a legal filing by his lawyer.
His lawyer didn’t immediately respond to an messages seeking further comment Thursday. An online court docket shows that an urgent motion seeking to halt the deportation proceedings was filed Tuesday against the Trump administration.
A Georgetown University webpage identifies Suri as a postdoctoral fellow at Alwaleed Bin Talal Center for Muslim-Christian Understanding at the university. The university said his areas of interest include religion, violence and peace processes in the Middle East and South Asia. The bio said that he earned a doctorate in India while studying efforts to introduce democracy to Afghanistan and Iraq, and he has traveled extensively in conflict zones in several countries.
The university said in a statement Thursday that Suri is an Indian national who was “duly granted a visa to enter the United States to continue his doctoral research on peacebuilding in Iraq and Afghanistan.”
“We are not aware of him engaging in any illegal activity, and we have not received a reason for his detention,” the school said. “We support our community members’ rights to free and open inquiry, deliberation and debate, even if the underlying ideas may be difficult, controversial or objectionable. We expect the legal system to adjudicate this case fairly.”
The US Customs and Immigration Enforcement detainee locator website lists Suri as being in the custody of immigration officials at the Alexandria Staging Facility in Louisiana.
Separately, Columbia University student activist Mahmoud Khalil, a legal US resident with no criminal record, was detained earlier this month over his participation in pro-Palestinian demonstrations and is fighting deportation efforts in federal court. And Dr. Rasha Alawieh, a kidney transplant specialist who previously worked and lived in Rhode Island, was deported over the weekend despite having a US visa.


Ukraine, US teams ready to meet in Saudi Arabia in ‘coming days’: Zelensky

Updated 20 March 2025
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Ukraine, US teams ready to meet in Saudi Arabia in ‘coming days’: Zelensky

Kyiv, Ukraine: Officials from Ukraine and the United States could meet in Saudi Arabia in the coming days for a second round of peace talks, Ukrainian President Volodymyr Zelensky said Wednesday.
“Ukrainian and American teams are ready to meet in Saudi Arabia in the coming days to continue coordinating steps toward peace,” Zelensky wrote on X.

 

 


One person dies as migrants aim to cross English Channel

Updated 20 March 2025
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One person dies as migrants aim to cross English Channel

  • Both the British and French governments have made tackling migrants crossing the English Channel illegally a high priority

PARIS: One person has died after a boat carrying migrants trying to cross the English Channel from France got into difficulties overnight, said a local French authority on Thursday.
The French local authority responsible for the North Sea and English Channel regions said 15 people had been rescued and brought back to shore at the port of Gravelines, near Dunkirk.
Both the British and French governments have made tackling migrants crossing the English Channel illegally – often in perilous conditions as they travel in dinghies or small boats – a high priority.
Data in January showed Britain’s Labour government had removed 16,400 illegal migrants since coming to power last July, marking the highest rate of such removals since 2018, although Labour’s political opponents say the government needs to do more.