Grail’s liquid biopsy today became the third pan-cancer blood test to be launched in the US. But it is being sold for a slightly different use versus the two approved tests. Galleri, which is not approved by the FDA but sold under a Clia waiver, is on sale as a screen, and can be used to test people aged over 50 at elevated risk of cancer. The other two tumour-agnostic liquid biopsies are used in patients who already have a confirmed cancer diagnosis, as a way to assess the mutations a tumour carries and therefore help assign targeted drugs. Grail is pitching its Galleri test at $949, quite a bit cheaper than both its rivals: Roche’s FoundationOne Liquid CDx sells at $5,800 and Guardant’s Guardant360 around $1,000 more than that. But the latter two have formal FDA approval, granted last August, making reimbursement easier – no reimbursement is yet in place for Galleri. Meanwhile Illumina’s $8bn bid to acquire Grail is no nearer closing. The FTC recentlywithdrew a lawsuit seeking to block the acquisition, which sounds like good news, but is in fact the opposite. The suit will likely be refiled later, delaying the deal's close further.
China National Pharmaceutical Group (Sinopharm) has the capacity to provide more than 1 billion COVID-19 vaccine doses to the world beyond China in the second half of this year, the firm's chairman Liu Jingzhen said late on Wednesday.
That level of supply capability assumes vaccination demand in China is being met, Liu said at a panel of the Global Health Forum of the Boao Forum for Asia.
"Our annual production capacity exceeds 5 billion doses," Liu said, "This is our own capacity."
He declined to disclose how many shots the state-backed drugmaker has agreed to give to the global COVAX programme for sharing doses, mainly with poor countries.
Two vaccines from Sinopharm are being used in China, one of which has gained emergency use approval from the World Health Organization, a prerequisite for a vaccine to be included in the COVAX initiative.
Liu said Sinopharm has also planned a manufacturing facility for a third shot, which is being tested in an early-stage clinical trial.
The GAVI vaccine alliance is in talks with Sinovac Biotech (SVA.O), another major COVID-19 vaccine provider from China, to expand the COVAX portfolio, a GAVI spokesperson said on Wednesday. read more
China promised in February to provide 10 million doses to COVAX.
57% in U.S. say lives are "somewhat" back to normal; 9% "completely"
For first time, majority think healthy people should lead normal lives
Record-high 84% think coronavirus situation is getting better
Now that the majority of Americans aged 18 and older are fully vaccinated against COVID-19 and restrictions meant to curb the spread of the disease are increasingly being rolled back, two-thirds of U.S. adults (66%) say their lives are either "somewhat" or "completely" back to normal.
While this marks a sharp reversal from October when a majority said their lives were not yet back to normal, few Americans -- 9% -- say life is completely back to normal, while 57% describe it as somewhat normal. The remaining 34% say normalcy has not yet returned.
Majority in U.S. Now Say Life Somewhat Back to Normal
Thinking about your life before the start of the coronavirus, would you say your life right now is -- completely back to normal, somewhat back to normal but not completely normal [OR] not yet back to normal?
Oct 2020
May 2021
Change
%
%
pct. pts.
Completely back to normal
3
9
+6
Somewhat back to normal
34
57
+23
Not yet back to normal
62
34
-28
GALLUP PANEL
The latest findings are from Gallup's May 18-23 COVID-19 probability-based web panel survey.
Almost all demographic subgroups of the population show large shifts since last fall in reports that their lives are back to normal. Additionally, similar proportions of major subgroups now say their lives are completely or somewhat back to normal, including by gender, age, region, household income, parental status and employment status.
One exception to these general patterns is that Democrats (57%) are less likely than independents (68%) or Republicans (77%) to say their lives are at least somewhat back to normal. Republicans were much more likely than other groups in October to say their lives were at least somewhat back to normal (67%); therefore, the change in Republicans' opinions has been less dramatic than those for other groups.
Change in Self-Reports of Life Being Back to Normal, by Political Party
Thinking about your life before the start of the coronavirus, would you say your life right now is -- completely back to normal, somewhat back to normal but not completely normal [OR] not yet back to normal?
Republicans
Independents
Democrats
Oct 2020 %
May 2021 %
Oct 2020 %
May 2021 %
Oct 2020 %
May 2021 %
Completely back to normal
8
17
2
10
1
2
Somewhat back to normal
59
60
30
58
20
55
Not yet back to normal
33
24
68
32
79
43
GALLUP PANEL
Americans may be unlikely to say their lives are completely back to normal because a majority, 52%, still say their life is being disrupted by the coronavirus, including 14% who report "a great deal" of disruption and 38% "a fair amount." While still a majority, the current figure is well below the high point -- 81% -- from late March/early April 2020 polling, when much of the country was still living under state-issued stay-at-home orders.
Currently, 57% believe the disruption caused by the virus will continue through the end of 2021 (39%) or longer than that (18%). This is a smaller majority expecting protracted disruption than the 67% recorded in April. Meanwhile, 11% of Americans today expect the disruption to continue a few more weeks, while 31% say a few more months.
Majority Now Think Healthy People Should Lead Normal Lives
As a sense of normalcy returns, Americans have become less likely to believe that the best advice for healthy people during the pandemic is to stay home to help prevent the spread of the virus, dropping from 91% in March 2020 to 67% at the start of this year to 44% now. In fact, for the first time in Gallup's COVID tracking, a majority (56%) say the better advice is for people to live their normal lives as much as possible.
Line graph. Trend from March 2020 to May 2021 in Americans' view that the better advice for healthy people during the pandemic is to stay home as much as possible to avoid contracting or spreading the coronavirus, rather than to lead their normal lives as much as possible. The percentage recommending staying home as much as possible has declined from a high of 91% last March to 67% in January and is 44% today.
As seen previously, there is a substantial partisan divide on the advice question, with 87% of Republicans versus 64% of independents and 29% of Democrats recommending people should strive to lead their normal lives. Conversely, 71% of Democrats believe people should stay home as much as possible, although this is down from 85% in April.
Optimism About Coronavirus Situation Hits New High
An increasingly larger share of U.S. adults (84%) think the coronavirus situation is getting better, a 15-percentage-point increase since April.
February was the first time that a majority said the situation was improving, after majorities said it was worsening for much of last summer through the end of 2020.
Line graph. Percentages of Americans who think the coronavirus situation in the U.S. is getting a lot or a little better since April 2020. Currently, 84% of U.S. adults say it is getting better, up from 69% in April and the highest on record.
Equal percentages now say the situation is getting "a lot better" as say "a little better," whereas the previous month twice as many said "a little better" as said "a lot better."
Currently, 11% in the U.S. say the situation is staying the same and 5% say it is getting "a lot" or "a little" worse.
Worry About Contracting COVID-19 at Lowest Point Since Beginning of Pandemic
Consistent with Americans becoming much more positive about the trajectory of the pandemic since January, their worry about contracting COVID-19 has decreased sharply over the same period.
The 20% of Americans who now say they are "very" or "somewhat" worried that they will get the disease is the lowest recorded over the past 14 months. This marks a 10-point drop in worry just since April and a 37-point drop since the end of 2020, when U.S. infections and deaths were spiking and the vaccine rollout was just beginning.
Line graph. Percentages of Americans who are very or somewhat worried about getting COVID-19 since April 2020. The latest 20% is the lowest on record, down from 57% late in 2020.
Satisfaction With Vaccine Rollout High; Leadership Ratings Less So
Americans are more pleased with the vaccine rollout now than at any point since it began, as 78% say they are "very" or "somewhat" satisfied. Satisfaction has steadily grown from 34% since late January.
Line graph. Americans' satisfaction with the COVID-19 vaccination process in the U.S. since January. Currently, 79% are either very satisfied or satisfied, up from 34% in January, 44% in February, 68% in March and 76% in April.
While Gallup does not directly ask the public whom they credit for the vaccination rollout, monthly coronavirus leadership ratings offer insight into how various players are perceived. Gallup has tracked Americans' ratings of state governors, the Centers for Disease Control and Prevention (CDC), and the president since last June for communicating a clear plan of action in response to the coronavirus.
Until President Joe Biden took office, state governors consistently received the highest marks for their communication of a clear pandemic response plan. Since his inauguration, however, Biden has far surpassed his predecessor, Donald Trump, and outpaced or tied state governors, while the CDC has the lowest ratings of the three for its communication.
Currently, 48% of U.S. adults agree that Biden has communicated a clear plan, while 45% say state governors have and 35% say the same of the CDC. The reading for the CDC is down six points since April, coming on the heels of its May 13 announcement that fully vaccinated Americans could remove their masks indoors. The new guidelines for mask use came as a surprise to many and reportedly led to some confusion among state government officials, business leaders and ordinary citizens.
Line graph. Americans' ratings of the communication of a clear plan of action in response to the coronavirus by the CDC, state governors and Joe Biden. Ratings represent the percentages who agree that each has communicated a clear plan. The readings for the CDC and state governors began in June and Biden's began in October. The latest reading finds 48% agree Biden has communicated a clear plan, 45% say their state governors have and 35% say the CDC has.
Bottom Line
Americans' concern about the coronavirus has greatly diminished as the majority are now at least partially vaccinated, cases have been dropping, and state and local restrictions on public activity have been cut back significantly or removed completely. As such, Americans for the first time endorse healthy people living their lives as normally as possible, and many more say their lives are personally getting back to normal, if not completely so.
Still, the public does not believe the U.S. is completely past the pandemic, with the majority saying they are experiencing COVID-related disruption in their lives and close to six in 10 expecting such disruption to persist in the U.S. through the end of the year or longer.
Choosing to skip the COVID-19 vaccine could be problematic for those who wish to travel if the Canada-U.S. border reopens on June 21.
According to a proposed system created by an expert advisory panel, Canadians who return from abroad would be divided into four categories: fully vaccinated, partially vaccinated, unvaccinated and exempt.
Anyone who has proof they received one dose of the vaccine would require a negative test within 72-hours of their departure, a negative PCR test when they return and must quarantine at home until they receive a second negative test in seven days.
Unvaccinated travellers would have the same requirement with an automatic 14-day quarantine upon returning to Canada unless they're exempt from border restrictions.
Windsor Regional Hospital CEO David Musyj says only fully vaccinated Canadian's would be able to return home without a quarantine if they pass a PCR test at the border.
"It's not set in stone right now, but everything is leading towards the need to be, at a minimum, partially vaccinated but most likely fully vaccinated to allow for easy travel there or coming home," he says.
Musyj says those hesitating on the vaccine who think they won't need it will likely be in for a surprise.
"They make their decision for whatever reason, but if they want to travel somewhere outside the province and out of Canada, they're probably going to need it," he says.
Musyj says a commitment to discuss a vaccine passport at the upcoming G7 Summit means G7 countries, including Canada, are taking the idea seriously.
"When a prime minister like Boris Johnson mentions he wants an agreement audited on vaccine passport and our government issues a statement saying, yup, we need to have that discussion and have it now," he added.
The proposed plan would require proof vaccination such as a receipt issued by government officials — Ontario residents can receive a copy online if they've misplaced their receipt.
Changes to vaccination status would only take effect 14-days from the date of receiving a dose.
Some immune cells in the brain protect against disease, while others cause inflammation and other problems that can actually lead to disease. Researchers at Washington University School of Medicine in St. Louis are shedding light on the differences between these immune cell populations in two new studies.
The researchers discovered that some immune cells originate in the skull and migrate to the meninges—the tissues that line the brain and spinal cord—without passing through the bloodstream. The sole job of those skull-based immune cells is to shield the brain from disease, they explained in the journal Science.
The discovery could boost drug development for a wide range of brain diseases, the researchers believe.
"There has been this gap in our knowledge that applies to almost every neurological disease: neuro-COVID, Alzheimer's disease, multiple sclerosis, brain injury, you name it," said senior author Jonathan Kipnis, Ph.D., professor of pathology and immunology at Washington University, in a statement. "We knew immune cells were involved in neurological conditions, but where were they coming from? What we've found is that there's a new source that hasn't been described before for these cells."
Kipnis and his team had previously demonstrated that immune cells in the meninges shield the brain from harmful invaders. For one of the two new studies, he and his colleagues focused on “innate” immune cells, which cause inflammation that can heal injuries and defend against disease. But these cells can also cause damage and contribute to diseases like Alzheimer’s.
A second Washington University team zeroed in on “adaptive” immune cells, which can destroy viruses and cancer but sometimes mistakenly attack healthy tissues, causing diseases like multiple sclerosis. The researchers discovered that B cells in the adaptive immune system originate and mature in the skull’s bone marrow.
Those B cells learn how to tell the difference between normal proteins and those that indicate the presence of disease. Because they migrate from the skull to the brain via channels other than blood, they maintain that ability to patrol the central nervous system without attacking normal proteins, the researchers explained.
A separate set of B cells does travel into the meninges from the blood—and these cells are not as good at distinguishing normal from abnormal proteins, according to that team. Meanwhile, Kipnis and his colleagues discovered that innate meningeal myeloid cells, which flood injured brain tissues, are inflammatory when they travel from the blood.
The influence of immune cells in the brain on neurological diseases is an area of intense research, much of which has been focused on microglia, a subset of myeloid cells that remove debris. Last year, for example, researchers at Stanford University spun off a startup, Tranquis Therapeutics, to target dysfunctional microglia in neurologic disorders. Its lead asset is a drug that restores a downregulated metabolic pathway in myeloid cells.
The Washington University researchers believe their discoveries about the origins of immune cells in the brain could be used to design new therapies for inflammatory brain disorders. "The location of these cells in the skull makes them relatively accessible, and opens up the possibility of designing therapies to alter the behavior of these cells and treat neuro-immune conditions," Kipnis said.
You’d think Amgen would still be celebrating in the halls after scoring an FDA approval for the KRAS inhibitor Lumakras just one week ago, but there’s just too much to do.
The Thousand Oaks, California-based biotechnology company is instead looking to a new cohort from the drug's pivotal trial, which is beginning to reveal the patients most likely to benefit from the drug, formerly known as sotorasib.
The new data, revealed Friday at the virtual American Society of Clinical Oncology meeting, could help Amgen move Lumakras up in the line of treatment for non-small cell lung cancer patients, a goal the company is actively working towards in other clinical trials.
Lumakras’ journey from “a twinkle in our eyes” to an approved product took only eight years, Amgen told Fierce Biotech last week. The FDA’s approval came months before the August action date, surprising pharmaceutical industry watchers and patients who were eagerly awaiting the decision.
“If you zoom out, the review wasn't just lightning fast, the entire program was lightning fast,” said Greg Friberg, Amgen VP and Therapeutic Area Head, Oncology, in an interview following the approval. “It's fantastic to be sitting here just under three years from the first patient being dosed and having that drug be available on the market for patients.”
Amgen intends to move fast to get the drug out to patients, too. The company had already built up a supply of product to ship out and Friberg estimates the first patients in the post-approval environment will receive doses within weeks.
“We've been moving at the fastest pace possible and the last thing we wanted was to have supply be a bottleneck. We're ready to go,” Friberg said. With the FDA approval in hand, Amgen is awaiting regulatory decisions around the world as well.
Meanwhile, at ASCO, the University of Texas MD Anderson Cancer Center’s Ferdinandos Skoulidis, M.D., Ph.D., is presenting findings from the phase 2 CodeBreaK 100 study that showed treatment with Lumakras induced a 37% objective response rate in patients and 12.5 months of median overall survival. These patients had KRAS G12C-mutated non-small cell lung cancer (NSCLC) and had previously received at least one or more rounds of treatment. Friberg said this study formed the “backbone” of the FDA application.
Skoulidis, assistant professor of Thoracic/Head & Neck Medical Oncology at MD Anderson, is thrilled that Lumakras is now approved and can be rolled out to patients, but he, like Amgen, says there’s still work to be done.
“If I were to use a boxing analogy, I would say that we have dealt KRAS a knockdown blow … [but] the fight is not over,” Skoulidis said in an interview.
Friberg estimates that with the approval in hand, the company and medical investigators like Skoulidis still “have a decade of work ahead of us” sorting through CodeBreaK and other studies involving the therapy.
“We're very early days,” Friberg said. “This is going to be a rich data set. We'll be using this data for some time to come.”
Amgen also plans to follow the patients in the trial for further long-term survival data, and Friberg hopes to see some long-term survivors coming back year after year.
The ASCO data did two things for Amgen: it began to reveal a picture of what is working and what isn’t in patients who receive the KRAS inhibitor. Or, in Friberg’s terms, what told a story and what did not tell a story. Amgen is now looking at the most granular data to ask why certain subsets of patients might have responded better, or why some did not.
“No story is a permanent negative, right? We ask the questions with the scientific method because we want to add anchor points,” Friberg said.
They found that patients with STK11 co-mutations did well on Lumakras, experiencing a 50% objective response, 11-month median progression-free survival and median overall survival of 15.3 months. Tumors with an STK11 mutation tend to have a poor response to standard-of-care therapies.
“A story is evolving here,” Friberg said. “It's important that we understand, particularly in cases where we know patients are in a very poor prognosis: Is this a drug that might be quite helpful for them and might be helpful earlier in their treatment?”
This co-mutation data is what Skoulidis found most interesting. He said the clinical activity seen in this subgroup of patients is “unprecedented and may suggest a clear avenue towards the further clinical development of sotorasib in the first-line disease setting.”
Skoulidis also pointed to a separate study to be presented at ASCO that discusses patient-reported outcomes on Lumakras, which is a once-daily oral medication. Treatment-related adverse events were mostly mild and manageable with care.
“This means that patients can enjoy an active life,” he said.
Going forward, Skoulidis wants to see more research on the molecular drivers of response to Lumakras and possible combination therapies that might prevent resistance.
Amgen has all that and more already going on in the clinic, but the data are still young. A first-line treatment trial is expected to kick off in the second half of the year.
Skoulidis and MD Anderson will continue to be involved in clinical trials for the therapy, including on the CodeBreaK 200 study that compares Lumakras with standard of care chemotherapy docetaxel. He’s also working on another clinical trial comparing the drug with other targeted therapies including checkpoint inhibitors.
Radiopharmaceuticals, along with cell and gene therapy, is one of the advanced drug platforms Novartis has pegged for long-term growth. But that ambition has hit a small setback.
Lutathera, the first radioligand therapy Novartis introduced to the market, failed to significantly prolong the lives of patients with midgut neuroendocrine tumors, according to data unveiled at the American Society of Clinical Oncology.
When used alongside Novartis’ own Sandostatin LAR in the phase 3 Netter-1 trial, Lutathera reduced the risk of death by 16% compared with solo Sandostatin LAR. But the improvement didn’t clear the statistical significance bar.
But Jonanthan Strosberg, M.D., principal investigator of the trial, was quick to note that adding Lutathera to the mix extended the median time patients lived by nearly a year; patients treated with the Lutathera regimen lived a median 48 months, versus 36.3 months for the control group.
“While not statistically significant, I consider this difference to be clinically relevant for these patients,” Strosberg said in a statement.
Multiple factors may have hurt Lutathera’s survival stats, Novartis said. A large number of patients in the control arm—about 36%—actually crossed over to receive Lutathera, Strosberg noted. Patients in the Netter-1 trial were allowed to receive other anti-cancer treatments after disease progression on their randomized treatment or upon finishing an 18-month treatment period.
Lutathera earned its initial FDA go-ahead in early 2018 for gastroenteropancreatic neuroendocrine tumors, after Netter-1 showed it could reduce the risk of disease progression or death by a whopping 79%. At that time, a planned interim analysis pointed to an estimated 48% reduction in the risk of death for Lutathera.
For a rare cancer type, Lutathera brought in sales of $445 million in 2020, in line with the prior year. The drug has so far been administered to more than 9,000 patients in Europe and U.S., according to Novartis Chief Medical Officer John Tsai.
“We believe in the potential of targeted radioligand therapy and are investing in new discovery and expansion of this important platform, including exploration of new radioisotopes and combinations with complementary mechanisms of action, such as immunotherapy and inhibitors of DNA damage response,” Tsai said in a statement Thursday.
Lutathera came to Novartis by way of its acquisition of Advanced Accelerator Applications. Netter-1 tested it in patients with well-differentiated, or G1, tumors. Novartis is now testing the drug in newly diagnosed patients with moderately- or poorly differentiated G2 and G3 tumors.
Also at ASCO, Novartis reported a phase 3 win for another radiotherapy dubbed 177Lu-PSMA-617, which it scored via the $2.1 billion buyout of Endocyte. The drug reduced the risk of death by 38% in patients with metastatic castration-resistant prostate cancer.
In addition to AAA and Endocyte, the Swiss drugmaker recently licensed rights to radioligand treatments targeting fibroblast activation protein, or FAP, from iTheranostics.
