Roche’s Tecentriq to be filed for early-stage liver cancer

 A regimen of Roche’s Tecentriq and Avastin has become the first immunotherapy-based combination to reduce the risk of liver cancer returning after surgery to remove the tumour in a phase 3 trial, according to the company.

The results of the IMbrave050 study in people with early-stage hepatocellular carcinoma (HCC) – the most common form of liver cancer – showed that the duo improved recurrence-free survival when compared with active surveillance alone, and will form the basis of regulatory filings in the US and Europe.

There is a desperate need for new adjuvant treatments for people with early-stage HCC, said Roche, as 70% to 80% of them will see their cancer return despite surgery.

Moreover, the incidence of liver cancer is on the rise worldwide, driven in part by an increase in fatty liver disease associated with obesity and diabetes, and mortality rates are going up. Overall, liver cancer is the third leading cause of cancer death.

In 2020, PD-L1 inhibitor Tecentriq (atezolizumab) was approved in combination with anti-VEGF antibody Avastin (bevacizumab) to treat patients with more advanced unresectable or metastatic HCC who have not received prior systemic therapy.

Approval for early-stage HCC would increase the eligible patient population for the regimen. Although, it’s worth noting that it is often hard to find liver cancer early because signs and symptoms often do not appear until it is in its later stages.

Surveillance for HCC in at-risk groups like those with viral hepatitis and liver cirrhosis is also under-deployed in clinical practice in many countries.

Roche said it is following up patients in the 662-patient study to see if the improvement in recurrence-free survival translates into an overall survival benefit.

Other checkpoint inhibitors have been tested for adjuvant treatment of early HCC treatable with surgery, including Merck & Co’s Keytruda (pembrolizumab) as a monotherapy in the ongoing KEYNOTE-937 study.

Bristol-Myers Squibb’s Opdivo (nivolumab) – with and without CTLA4 inhibitor Yervoy (ipilimumab) – is also being tested in a phase 2 trial run by the MD Anderson Cancer Center in the US that was due to complete towards the end of last year, but so far no results have been posted.

The IMbrave050 readout is welcome news for Roche and its aspiration to move Tecentriq earlier on in the treatment pathway for cancer, coming after the drink flunked a study in the adjuvant kidney cancer setting last year.

The drug is already cleared for use post-surgery and chemotherapy to prevent relapse in some non-small cell lung cancer (NSCLC) patients – on its own considered a $1 billion opportunity by some analysts.

https://pharmaphorum.com/news/roches-tecentriq-to-be-filed-for-early-stage-liver-cancer/

US Coast Guard Monitoring Suspected Russian Spy Ship Off Hawaii

 The US Coast Guard has announced that it is closely monitoring a suspected Russian spy ship not far off the coast of Hawaii, and that the vessel has been lingering there for weeks.

"In recent weeks, the US Coast Guard has continued to monitor a Russian vessel, believed to be an intelligence gathering ship, off the coast of the Hawaiian Islands," a Coast Guard press release said.

"While foreign military vessels may transit freely through the U.S. economic exclusive zone (EEZ), as per customary international laws, foreign-flagged military vessels have often been observed operating and loitering within Coast Guard District Fourteen’s area of response," it added.

On Wednesday the Coast Guard in addition to the fresh announcement shared a clip of the alleged Russian spy ship's movements near Hawaii.

The brief surveillance footage released to the public clearly shows a fast-moving military ship being monitored by what's likely a drone or plane...

Last May, US Indo-Pacific Command had been alerted to the movements of another Russian ship near Hawaii, which the US military tracked before it exited the area. US and Russian encounters at sea or in the air near Hawaii remain relatively rare, while there are typically a handful of such incidents off the Alaskan coast, usually involving Russian long-range bombers patrolling the Barents Sea.

Earlier this week Russia said it intercepted and escorted a German maritime patrol plane over the Baltic Sea when it approached Russian territory, at a moment tensions with NATO are soaring due to the war in Ukraine. Addressing the Monday confrontation, the Russian Defense Ministry described, "After the foreign military aircraft turned away from the state border of the Russian Federation, the Russian fighter returned to its home airfield."

https://www.zerohedge.com/military/us-coast-guard-monitoring-suspected-russian-spy-ship-hawaii

Tenet Sees Beating Midpoint of Latest 2022 Outlook; No '23 Outlook Yet

 Tenet Healthcare Corporation (Tenet) (NYSE: THC) announced today that it expects to exceed the midpoint of its latest FY22 Adjusted EBITDA Outlook range included in its third quarter 2022 earnings release along with key leadership updates that will help support long-term business performance.

Although Tenet’s financial statement close process is not yet fully completed, the Company anticipates its Adjusted EBITDA, excluding any fourth quarter stimulus grant income related to the pandemic, will be slightly above the mid-point of its Adjusted EBITDA guidance of $3.425 billion for the year ended December 31, 2022.

"Our business units continued to demonstrate effective management capabilities and delivered strong results in the fourth quarter," said Saum Sutaria, M.D., Chief Executive Officer of Tenet. "All three of our business units are expected to produce Adjusted EBITDA excluding grant income that was at or slightly above the mid-point of our guidance. We look forward to providing more details in a few weeks along with sharing plans to support a successful 2023."

https://finance.yahoo.com/news/tenet-anticipates-beating-midpoint-latest-114500988.html

Alpine Immune started at Overweight by Morgan Stanley

 Target $17

https://finviz.com/quote.ashx?t=ALPN&p=d

Households earning $100k or more cutting back more aggressively on spending. What's going on?

 More U.S. adults said their monthly expenses exceeded their monthly income in December, according to a report released this week

Higher-earning households are feeling the inflationary pinch.

Consumer spending slowed and household finances weakened across all income levels last month. But households earning $100,000 a year or more reported shaving more off their spending than less well-off households did, according to a report released this week by Morning Consult, a decision intelligence company.

The report also found that real monthly spending among U.S. adults fell by 4.3% from November to December.Even so, 21.3% of U.S. adults said their monthly expenses exceeded their monthly income in December, up from 19.2% in November.

On average, households earning $100,000 a year or more said they spent about 10% less in real terms in December than they did the previous month. Households earning $50,000 to $99,999 and those earning less than $50,000 a year, meanwhile, reported that they cut their monthly spending bills by no more than 5% on average.

Across the board, households are cutting back on recreation, alcohol, vehicle insurance, and other services in December, while spending more on hotels, gas and airfares, the report found.

One theory on the spending cutbacks: Higher earners typically have more discretionary income, and likely have decided to exercise more fiscal caution after seven interest-rate hikes by the Federal Reserve last year. (On Wednesday, St. Louis Fed President James Bullard told The Wall Street Journal in a live-streamed interview that the Federal Reserve should not "stall" on raising its benchmark rates until they are above 5%.)

The Morning Consult report did cite inflationary pressures. "Heightened budgetary pressures brought on by persistently high inflation are forcing trade-offs for consumers, leading to reallocation across categories," it said. "For instance, as food grew more expensive over the past year, U.S. households accommodated an increase in grocery purchases by spending less at restaurants."

Earlier last year, higher-income households led consumer spending in the face of rising prices, said Kayla Bruun, an economic analyst with Morning Consult and co-author of the report. But household income, even for those earning six-figure incomes, has not been growing fast enough to keep up with inflation, she said.

"They probably started to realize, 'Hey, I can't keep buying the same basket of goods each month and expect to continue adding to my savings,'" Bruun told MarketWatch.

At the same time, recent layoffs in the higher-earning tech and financial sectors may also have affected sentiment among wealthier households, Bruun said.

The tech and financial sectors felt the impact of rising interest rates and economic headwinds, she added. Goldman Sachs(GS) and BlackRock(BLK) said earlier this month they were cutting jobs. Microsoft Corp. (MSFT) confirmed plans on Wednesday to lay off some 10,000 workers, equivalent to around 5% of the company's global workforce.

Before Microsoft's announcement, data compiled by the Layoffs.fyi website estimated that more than 25,000 global tech-sector employees have been laid off in the first few weeks of 2023. Last year, approximately 60,000 people in the tech industry were laid off, according to Challenger, Gray & Christmas.

Still, there has been some good news: Inflation eased in December for the sixth consecutive month: The annual rate of inflation fell to 6.5% from 7.1% in November after reaching a four-decade-high of 9.1% last summer.

https://www.morningstar.com/news/marketwatch/20230119443/households-earning-100000-or-more-are-cutting-back-more-aggressively-on-spending-whats-going-on

US officially hits debt limit, begins 'extraordinary measures' to pay bills

 The U.S. government hit its borrowing limit Thursday, causing the Treasury to activate "extraordinary measures" to keep paying the government's bills.

Treasury Secretary Janet Yellen sent a letter Thursday morning to House Speaker Kevin McCarthy, noting that a "debt issuance suspension period" will begin on Thursday, Jan. 19 and last through Monday, June 5.

As part of that, the government will not funnel new investments into the Civil Service Retirement and Disability Fund, as well as suspend investments into a retiree health benefits fund for retired post office workers. Federal retirees and employees will be unaffected by these actions.

Yellen said once the debt limit is increased, these funds will be made whole.

Yellen reiterated that while she anticipates measures taken to head of a default will last until early June, it’s subject to uncertainty.

"As I stated in my January 13 letter, the period of time that extraordinary measures may last is subject to considerable uncertainty, including the challenges of forecasting the payments and receipts of the U.S. Government months into the future," Yellen wrote. "I respectfully urge Congress to act promptly to protect the full faith and credit of the United States."

Many Republicans have said they will block any attempts to increase borrowing authority in the coming months without deep concessions on spending, while Democrats have vowed to refuse to negotiate over the issue at all.

Programs ranging from Social Security benefits to tax refunds to military salaries would be impacted in the event of a default. Economists have warned a default could send the economy into a recession.

Republicans are reportedly drawing up a plan that would tell Treasury which payments to prioritize if lawmakers weren’t able to come to a deal and extraordinary measures were to run out.

Former senior public affairs officer for the Treasury, John Rizzo, called a Republican plan to specify which payments to prioritize, a de-facto default.

https://finance.yahoo.com/news/us-officially-hits-debt-limit-begins-extraordinary-measures-to-pay-bills-161812975.html

Jazz, Zymeworks: 84% Overall Survival at 18 Months in Phase 2 GI Cancer Trial

 Results presented today at ASCO GI include first overall survival (OS) data for zanidatamab, overall confirmed objective response rate (cORR) of 79%, disease control rate (DCR) of 92%, and median progression-free survival (mPFS) of 12.5 months

Ongoing Phase 3 randomized clinical trial, HERIZON-GEA-01, has the potential to support regulatory submissions for zanidatamab in combination with chemotherapy as a therapeutic option for patients with advanced HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA)

https://finance.yahoo.com/news/jazz-pharmaceuticals-zymeworks-announce-84-124500965.html