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
Pakistan locks down capital ahead of a planned rally by Imran Khan supporters
- Interior Ministry is considering a suspension of mobile phone services in parts of Pakistan in the coming days
- Pakistan has banned gatherings of five or more people in Islamabad for two months to deter Khan’s supporters
It’s the second time in as many months that authorities have imposed such measures to thwart tens of thousands of people from gathering in the city to demand Khan’s release.
The latest lockdown coincides with the visit of Belarusian President Alexander Lukashenko, who arrives in Islamabad on Monday.
Local media reported that the Interior Ministry is considering a suspension of mobile phone services in parts of Pakistan in the coming days. On Friday, the National Highways and Motorway Police announced that key routes would close for maintenance.
It advised people to avoid unnecessary travel and said the decision was taken following intelligence reports that “angry protesters” are planning to create a law and order situation and damage public and private property on Sunday, the day of the planned rally.
“There are reports that protesters are coming with sticks and slingshots,” the statement added.
Multicolored shipping containers, a familiar sight to people living and working in Islamabad, reappeared on key roads Saturday to throttle traffic.
Pakistan has already banned gatherings of five or more people in Islamabad for two months to deter Khan’s supporters and activists from his Pakistan Tehreek-e-Insaf party, or PTI.
Khan has been in prison for more than a year in connection and has over 150 criminal cases against him. But he remains popular and the PTI says the cases are politically motivated.
A three-day shutdown was imposed in Islamabad for a security summit last month.
Indian man awakes on funeral pyre
- Doctors sent Rohitash Kumar, 25, to mortuary instead of conducting postmortem after he fell ill
- Kumar was rushed to hospital on Friday for treatment but was confirmed dead later
JAIPUR: An Indian man awoke on a funeral pyre moments before it was to be set on fire after a doctor skipped a postmortem, medical officials said Saturday.
Rohitash Kumar, 25, who had speaking and hearing difficulties, had fallen sick and was taken to a hospital in Jhunjhunu in the western state of Rajasthan on Thursday.
Indian media reported he had had an epileptic seizure, and a doctor declared him dead on arrival at the hospital.
But instead of the required postmortem to ascertain the cause of death, doctors sent him to the mortuary, and then to be burned according to Hindu rites.
D. Singh, chief medical officer of the hospital, told AFP that a doctor had “prepared the postmortem report without actually doing the postmortem, and the body was then sent for cremation.”
Singh said that “shortly before the pyre was to be lit, Rohitash’s body started movements,” adding that “he was alive and was breathing.”
Kumar was rushed to hospital for a second time, but was confirmed dead on Friday during treatment.
Authorities have suspended the services of three doctors and the police have launched an investigation.
NATO chief discusses ‘global security’ with Trump
- NATO allies say keeping Kyiv in the fight against Moscow is key to both European and American security
Brussels: NATO chief Mark Rutte held talks with US President-elect Donald Trump in Florida on the “global security issues facing the alliance,” a spokeswoman said Saturday.
The meeting took place on Friday in Palm Beach, NATO’s Farah Dakhlallah said in a statement.
In his first term Trump aggressively pushed Europe to step up defense spending and questioned the fairness of the NATO transatlantic alliance.
The former Dutch prime minister had said he wanted to meet Trump two days after Trump was elected on November 5, and discuss the threat of increasingly warming ties between North Korea and Russia.
Trump’s thumping victory to return to the US presidency has set nerves jangling in Europe that he could pull the plug on vital Washington military aid for Ukraine.
NATO allies say keeping Kyiv in the fight against Moscow is key to both European and American security.
“What we see more and more is that North Korea, Iran, China and of course Russia are working together, working together against Ukraine,” Rutte said recently at a European leaders’ meeting in Budapest.
“At the same time, Russia has to pay for this, and one of the things they are doing is delivering technology to North Korea,” which he warned was threatening to the “mainland of the US (and) continental Europe.”
“I look forward to sitting down with Donald Trump to discuss how we can face these threats collectively,” Rutte said.
Indian man awakes on funeral pyre
JAIPUR, India: An Indian man awoke on a funeral pyre moments before it was to be set on fire after a doctor skipped a postmortem, medical officials said Saturday.
Rohitash Kumar, 25, who had speaking and hearing difficulties, had fallen sick and was taken to a hospital in Jhunjhunu in the western state of Rajasthan on Thursday.
Indian media reported he had had an epileptic seizure, and a doctor declared him dead on arrival at the hospital.
But instead of the required postmortem to ascertain the cause of death, doctors sent him to the mortuary, and then to be burned according to Hindu rites.
D. Singh, chief medical officer of the hospital, told AFP that a doctor had “prepared the postmortem report without actually doing the postmortem, and the body was then sent for cremation.”
Singh said that “shortly before the pyre was to be lit, Rohitash’s body started movements,” adding that “he was alive and was breathing.”
Kumar was rushed to hospital for a second time, but was confirmed dead on Friday during treatment.
Authorities have suspended the services of three doctors and the police have launched an investigation.
Fighting between armed sectarian groups in restive northwestern Pakistan kills at least 33 people
- Senior police officer said Saturday armed men torched shops, houses and government property overnight
- Although the two groups generally live together peacefully, tensions remain, especially in Kurram
PESHAWAR: Fighting between armed Sunni and Shiite groups in northwestern Pakistan killed at least 33 people and injured 25 others, a senior police officer from the region said Saturday.
The overnight violence was the latest to rock Kurram, a district in Khyber Pakhtunkhwa province, and comes days after a deadly gun ambush killed 42 people.
Shiite Muslims make up about 15 percent of the 240 million people in Sunni-majority Pakistan, which has a history of sectarian animosity between the communities.
Although the two groups generally live together peacefully, tensions remain, especially in Kurram.
The senior police officer said armed men in Bagan and Bacha Kot torched shops, houses and government property.
Intense gunfire was ongoing between the Alizai and Bagan tribes in the Lower Kurram area.
“Educational institutions in Kurram are closed due to the severe tension. Both sides are targeting each other with heavy and automatic weapons,” said the officer, who spoke anonymously because he was not authorized to speak to the media.
Videos shared with The Associated Press showed a market engulfed by fire and orange flames piercing the night sky. Gunfire can also be heard.
The location of Thursday’s attack was also targeted by armed men, who marched on the area.
Survivors of the gun ambush said assailants emerged from a vehicle and sprayed buses and cars with bullets. Nobody has claimed responsibility for the attack and police have not identified a motive.
Dozens of people from the district’s Sunni and Shiite communities have been killed since July, when a land dispute erupted in Kurram that later turned into general sectarian violence.
