AbbVie's Elahere has been shown to reduce the risk of death in patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer by a third, reinforcing its blockbuster credentials.
New data from the phase 3 MIRASOL trial presented at the Society of Gynaecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle over the weekend showed that after more than 30 months of follow-up, overall survival was 32% improved with Elahere (mirvetuximab soravtansine) compared to chemotherapy.
Median OS came in at nearly 17 months for the Elahere group, compared to just over 13 months for chemo, while median progression-free survival (PFS) was 5.6 and 4 months, respectively.
The study enrolled adults with platinum-resistant, FRα-expressing high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. FRα is considered a marker of tumour aggressiveness, associated with poorer response rates to treatment, and is over-expressed in around a third of ovarian cancer patients.
The new survival data comes as AbbVie is already seeing strong take-up of Elahere, which was the centrepiece of its $10.1 billion takeover of ImmunoGen in 2023. The drug was given accelerated approval in the US in 2022, which was upgraded to full approval a year ago, and was also cleared in Europe last November.
AbbVie has pointed to a very strong launch trajectory for Elahere, with sales rocketing to $480 million last year, almost entirely from the US market and before the contribution from Europe was ready to kick in. It is modelling sales of $750 million this year.
The drug has the potential to revolutionise the management of patients with this type of cancer, according to AbbVie, which notes the lack of treatment options for women whose disease stops responding to platinum-based chemotherapy. Elahere is the first drug to improve survival in platinum-resistant ovarian cancer.
"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey," said Svetlana Kobina, AbbVie's head of oncology medical affairs.
"The data presented today reinforce the importance of Elahere as a transformative therapy for patients with limited options," she added.
AbbVie is also trying to extend the indications for the FRα-targeting antibody-drug conjugate (ADC), with a phase 3 study on the go in platinum-sensitive ovarian cancer, and will also be tested as a combination therapy with bevacizumab, carboplatin, and a PARP inhibitor. The company also has a follow-up FRα-targeting ADC – IMGN-151 – which is in phase 1.
GlobalData has predicted that, with its first-to-market advantage, Elahere could generate $2.8 billion in 2029. One potential rival is Eisai's farletuzumab ecteribulin, another ADC that was licensed to Bristol Myers Squibb (BMS) in a $3.1 billion deal that was dissolved last year. Eisai is testing the drug in a pair of phase 2 trials in ovarian and non-small cell lung cancer (NSCLC).
A Rhode Island doctor who is an assistant professor at Brown University's medical school has been deported to Lebanon even though a judge had issued an order blocking the U.S. visa holder's immediate removal from the country, according to court papers.
The expulsion of Dr. Rasha Alawieh, 34, is set to be the focus of a hearing on Monday before a federal judge in Boston, who on Sunday demanded information on whether U.S. Customs and Border Protection had "willfully" disobeyed his order.
U.S. District Judge Leo Sorokin, an appointee of Democratic President Barack Obama, said he had received a "detailed and specific" timeline of the events from an attorney working on Alawieh's behalf that raised "serious allegations" about whether his order was violated.
CBP had no immediate comment.
The agency has not said why she was removed. But her expulsion came as Republican U.S. President Donald Trump's administration has sought to sharply restrict border crossing and ramp up immigration arrests.
Alawieh, a Lebanese citizen who lives in Providence, was detained on Thursday after arriving at Logan International Airport in Boston after traveling to Lebanon to see relatives, according to a lawsuit filed by her cousin, Yara Chehab.
She had held a visa to be in the United States since 2018, when she first came to complete a two-year fellowship at Ohio State University before then completing a fellowship at the University of Washington and then moving to the Yale-Waterbury Internal Medicine Program, which she completed in June.
While in Lebanon, the U.S. consulate issued Alawieh an H-1B visa authorizing her entry into the United States to work at Brown University, the lawsuit said. Such visas are reserved for people from other countries who are employed in specialty occupations.
Despite that visa, CBP detained her at the airport for reasons her family members have still not been provided, according to the lawsuit, which argued her rights were being violated.
In response to the lawsuit, Sorokin on Friday evening issued orders barring Alawieh's removal from Massachusetts without 48 hours' notice to the court and requiring her to be brought to a court hearing on Monday.
Yet according to the cousin's attorneys, after that order was issued, Alawieh was flown to Paris, where she was then set to board a flight for Lebanon that had been scheduled for Sunday.
Sorokin on Sunday directed the government to provide a legal and factual response by Monday morning ahead of the previously scheduled hearing and to preserve all emails, text messages and other documents concerning Alawieh's arrival and removal.
We’ve all seen the movies. Two countries are hostile, but not engaged in a hot war. One of the countries sends small, furtive bands of soldiers, all disguised as civilians, into the other country, to destabilize it or, at the appropriate moment, to cast off their disguises for a hot war. Or perhaps, one country sends the other a beautiful wooden horse filled with soldiers... None of this is unrealistic. Today, hostile nations, in an undeclared war against America, send their violent, criminal foot-soldiers here to destabilize our country.
Donald Trump understands what’s happening and sought to use a statute that empowers him to fight this covert warfare...only to have an Obama-nominated district court judge arrogate to himself the constitutional executive’s plenary power over America’s foreign policy and national security.
The military tactic of sending small bands of disguised troops into an enemy country is as old as war itself—and of course, our well-educated Founders fully understood this. That’s why, in 1798, the same generation that ratified the Constitution in 1787 and the Bill of Rights in 1791 (so it must be presumed to have understood what those documents meant), passed the Alien Enemies Act, one of a series of four acts designed to protect the new nation from enemy action.
The substantive portion of 50 U.S. Code § 21 is short, so I’ll quote it in its entirety (emphasis mine):
Whenever there is a declared war between the United States and any foreign nation or government, or any invasion or predatory incursion is perpetrated, attempted, or threatened against the territory of the United States by any foreign nation or government, and the President makes public proclamation of the event, all natives, citizens, denizens, or subjects of the hostile nation or government, being of the age of fourteen years and upward, who shall be within the United States and not actually naturalized, shall be liable to be apprehended, restrained, secured, and removed as alien enemies. The President is authorized in any such event, by his proclamation thereof, or other public act, to direct the conduct to be observed on the part of the United States, toward the aliens who become so liable; the manner and degree of the restraint to which they shall be subject and in what cases, and upon what security their residence shall be permitted, and to provide for the removal of those who, not being permitted to reside within the United States, refuse or neglect to depart therefrom; and to establish any other regulations which are found necessary in the premises and for the public safety.
In sum, when a foreign government authorizes a “predatory incursion” into the US, the president, and only the president, after announcing that this is, in fact, a foreign nation’s predatory act against America, may then apprehend and deport select citizens of that foreign nation. The act clearly does not require that he deport every citizen of that nation resident in America; only those whom the president, in his sole discretion, deems a threat.
This brings us to the Tren de Aragua gang members who came from Venezuela to America and have been terrorizing American communities. Unlike many illegal aliens who come here for jobs or welfare, these “immigrants” are part of “weaponized migration” intended to destabilize America by overloading its systems and flooding us with hardcore criminals.
In an essay about Nicaragua’s weaponized migration against the U.S., Manuel Orozco describes not just Nicaragua’s acts, but also the general principle behind the bands of covert foreign warriors sent to America:
The third axis of the regime is one of ‘weaponizing’ migration to damage the United States.
A reality of the post-pandemic period is that 18 countries (China, Colombia, Cuba, Ecuador, El Salvador, Guatemala, Haiti, Honduras, India, Mexico, Myanmar, Nicaragua, Peru, Philippines, Russia, Turkey, Ukraine, and Venezuela) represent 92 percent of all irregular migration that reaches the border with Mexico.
The family clan identified these nationalities and took advantage of the economic and political opportunity to ‘weaponize’ migration as a foreign policy against the United States and increased the weight of the humanitarian crisis.
Venezuela’s Nicolás Maduro has followed the same tactic. Thus, in 2022, the Department of Homeland Security apparently issued an intelligence report indicating that Maduro was deliberately sending Venezuela’s most violent prisoners to America.
This is precisely the activity the Alien Enemies Act was intended to counter.
In accordance with the authority the Founders’ generation gave to the Commander in Chief to protect America, Trump attempted to deport hundreds of Tren de Aragua members expeditiously, without spending endless time and taxpayer funds going through the immigration system. To that end, he explicitly invoked the Act, and then put Tren de Aragua members on airplanes back to Venezuela. And note, again, that the act empowers only the executive to determine which aliens are enemies, and which are not.
One D.C. federal district court judge, James Boasberg, however, decided to arrogate to himself that unique executive authority. Yesterday, moments after the flight with the gang members departed, he ordered the plane returned to the U.S.
The judge did so because he was swayed by arguments from lawyers on behalf of these violent criminals (who stand accused of crimes such as drug and sex trafficking, murder, assault, pedophilia, etc.) claiming that it was just wrong for the president to have the power the act confers upon him:
“There’s nothing in the law itself that would require it to be limited to undocumented individuals or individuals who have committed crimes,” said Katherine Yon Ebright, counsel on the liberty and national security team at the center-left Brennan Center for Justice. “It’s not about legal status, consistent with the idea that it’s a wartime authority, not an immigration authority.”
As noted, this is just wrong.
Americans of all colors, races, creeds, countries of national origin, etc., desperately want their communities made safe again. And the Democrats, equally desperately, want the world’s most violent criminals to spread throughout America. While the world’s dictators send in their columns, the Democrats have activated their Fifth Columnists.
Faced with an April 5 deadline, the White House is reportedly weighing a "high-level agreement" for Oracle to be the winner of the TikTok sweepstakes under a forced deal to decouple the application from its Chinese roots.
Vice President JD Vance alluded to the potential sale agreement Friday as required by Congress amid national security concerns with China-based ownership of the popular social media app that requires forced technology transfer, giving the Chinese Communist Party access to Americans' data.
Sources told Politico that Oracle founder and Executive Chair Larry Ellison, a longtime backer of President Donald Trump, is the leading bidder of the agreement the White House is weighing, but the sources express concern that national security might remain compromised.
Congress, in a bipartisan push, passed a law that former President Joe Biden signed that required the sale of TikTok by its China-tied parent ByteDance, but sources told Politico that Oracle's agreement might only provide a cursory fix to address concerns.
That is why lawmakers are bringing in Oracle to talk about the security details this week, according to the report.
"If the Oracle deal moves forward, you still have this [algorithm] controlled by the Chinese," a source told Politico. "That means all you are doing is saying 'trust Oracle' to disseminate the data and guarantee there is no 'back door' to the data."
Vance said Friday that he was hopeful a deal to keep TikTok operating in the U.S. will be wrapped up by the early April deadline.
"There will almost certainly be a high-level agreement that I think satisfies our national security concerns, allows there to be a distinct American TikTok enterprise," Vance said aboard Air Force Two.
Questions about the future of the popular video sharing app have continued to linger since a law requiring its China-based parent company to divest or face a ban took effect Jan. 19. After taking office, Trump gave TikTok a 75-day reprieve by signing an executive order that delayed enforcement of the statute until April 5.
Vance, along with national security adviser Michael Waltz, were tapped by Trump to find an approved buyer.
"We'd like to get it done without the extension," Vance said. "I think the question is, What is the equity ownership of the new joint venture? How do you do the contracts for all the investors, the customers, the service providers?
"The deal itself will be very clear, but actually creating those thousands and thousands of pages of legal documents, that's the one thing that I worry could slip."
Trump has previously said the deadline on a TikTok deal could be extended further if needed.
He has also proposed terms in which the U.S. would have a 50% stake in a joint venture. The administration has not provided details on what that type of deal would entail.
Last weekwe notedreporting by journalist Alex Berensen, whocitedtwo large German newspapers in revealing that Germany's Federal Intelligence Service (BND) has long had evidence that the Covid-19 virus originally came from a US-funded lab in Wuhan, China.
According to these reports, at the beginning of the Covid-19 pandemic in Europe in 2020, the German government commissioned a secret intelligence operation under the codename of Saaremaa to investigate the origins of the Covid-19 virus, also known as SARS-CoV-2. When they concluded that a lab leak was most likely, the German Chancellery ordered that the results were to be kept hidden from the public.
The UK Knew Too...
Now, the Daily Mail reports that "a former spy chief submitted a secret dossier to No 10 early in the pandemic reporting that the virus had originated with a leak from a Wuhan facility."
Except that Patrick Vallance, the UK's equivalent of Anthony Fauci, quashed it.
A classified dossier compiled by Sir Richard Dearlove, the former head of MI6, was passed to then-Prime Minister Boris Johnson at the start of the outbreak in March 2020 which stated: 'It is now beyond reasonable doubt that Covid-19 was engineered in the Wuhan Institute of Virology'.
The file, marked 'Secret – Recipient's Eyes Only' argued that Beijing was pushing a fake narrative that the virus had originated in an animal market. The dossier, compiled by a group of eminent academics and intelligence experts and seen by The Mail on Sunday, said China even retrospectively manipulated viral samples to give credence to the deception.
But the argument is said to have been dismissed by Patrick Vallance, who was a familiar face during the pandemic as he flanked Mr Johnson at No 10 news conferences.
In a new statement from Dearlove, he writes that "Boris himself was persuaded by its argument. But the weight of the Government's scientific establishment, already signed up to the Chinese narrative, prevailed."
Last night, a source close to Mr Johnson pointed the finger at Lord Vallance for rubbishing the lab-leak theory in order to appease the Chinese government. The source said: 'Boris repeatedly asked the [intelligence] agencies to do more work on the origins of Covid. It struck him as simply too much of a coincidence that a mutant Covid virus appeared in a city that just happened to possess one of the only labs in the world that engineered mutant Covid viruses.
NYT Offers Lame 'Mea Culpa'
In light of the two reports, the NY Times - which peddled natural origin propaganda while slamming lab-leak proponents, has penned a mea culpa of sorts that boils down to 'we had bad information, oops!'
We have since learned, however, that to promote the appearance of consensus, some officials and scientists hid or understated crucial facts, misled at least one reporter, orchestrated campaigns of supposedly independent voices and even compared notes about how to hide their communications in order to keep the public from hearing the whole story. And as for that Wuhan laboratory’s research, the details that have since emerged show that safety precautions may have been terrifyingly lax.
Let's Review
Prior to 2014, Fauci / NIAID were funding gain-of-function research on US soil, specifically manipulating bat covid under the guise of preventing the next pandemic. One of the methods they explored was 'survival of the fittest' - i.e. feed enough non-human infecting cells human ACE2 receptors in a petri dish until a tiny fraction of them evolved, then culture those. This avoided a detectable 'seam' on the virus that would otherwise prove manmade (CRISPR) engineering.
Ralph Baric of the University of North Carolina (And USAMRIID of 'hot zone' fame) bred special 'humanized' mice with ACE2 receptors that mimicked a human's in collaboration with WIV. This was a key step.
Baric asked Shi if he could have the genetic data for SHC014. “She was gracious enough to send us those sequences almost immediately,” he says. His team introduced the virus modified with that code into mice and into a petri dish of human airway cells. Sure enough, the chimera exhibited “robust replication” in the human cells—evidence that nature was full of coronaviruses ready to leap directly to people.
Several months before the ban, Fauci gave NY nonprofit EcoHealth Alliance a contract to continue the same research in Wuhan.
While operating in Wuhan, EcoHealth approached DARPA with a leaked proposal called DEFUSE, which outlined a method to genetically modify bat COVID to infect humans with an aerosol transmission. DARPA declined, but it was effectively a roadmap for creating COVID-19. The fact pattern goes more or less cold after this (we have no evidence they pressed on and did it anyway).
Then, a human-infecting bat coronavirus broke out across town from the US-funded lab experimenting with human-infecting bat coronavirus, which was never found in nature. Jon Stewart nailed it.
After it broke out, some of Fauci's own advisers said 'this looks manmade as fuck, sir' - which Fauci encouraged them to reconsider. 48 hours later they were all onboard the natural origin train with EcoHealth Alliance President Peter Daszak spearheading their response (that did not disclose his conflict of interest, and Lancet later apologized for that), and the ensuing "Proximal Origins" paper by Kristian Andersen (one of the guys on the Fauci call who changed his mind).
emails released a year after the pandemic’s beginning showed that Andersen initially thought the virus had been genetically engineered. However, after a phone call with Fauci and another major virology funder, Jeremy Farrar, then with the Wellcome Trust, Andersen reversed course.
Andersen continues to lie about it (this was written by former Senate investigator, Paul Thacker).
Now we know:
The former head of MI6 told Boris Johnson it was likely a lab leak in 2020, but Johnson's equivalent of Fauci shot it down.
The US State Department was issuing internal warnings over the Wuhan Lab that leaked to WaPo in April 2020.
In January, the (Biden) CIA updated their opinion to Lab Leak. Chris Cillizza apologized.
So the obvious answer is that the natural origin campaign, which was of course amplified by mainstream outlets, was designed to conceal the likely path to where we are now.
GE Aerospace has secured a contract with the U.S. Air Force worth up to $5 billion.
The commercial and military aircraft company said Friday it had an indefinite delivery, indefinite quantity contract to make engines for the Air Force.
The contract supports foreign military sales for F110-GE-129 engines, which power F-15 and F-16 aircrafts.
As part of the agreement, GE will work with the Air Force to deliver engines, spares and services to operators in allied nations, the company said.
North Korea said on Monday it will steadily upgrade and bolster its nuclear armed forces and blamed the foreign ministers of G7 states for infringing on its sovereign rights by demanding the end of its nuclear weapons programme, state media reported.
