Esmo 2021 – Spectrum poziotinib could add first-line string to its bow

 Spectrum’s poziotinib keeps throwing up surprises. Its multi-cohort Zenith20 lung cancer study had whiffed twice and yielded one surprising hit, on the basis of which the group plans a US filing this year. But a late-breaking Esmo abstract just made public suggests that the project could have broader potential: cohort 4, in first-line NSCLC patients whose cancer harbours Her2 exon 20 insertion, is also positive. The stated 44% confirmed remission rate in 48 subjects appears comfortably to hit Spectrum’s success criteria, and there are another two responses as yet unconfirmed. Twice-daily dosing in cohort 4 continues, but the Esmo data relate to once-daily, the same dose that Spectrum will take to the FDA in a filing focused on relapsed Her2 exon 20 insertion NSCLC. As for competition, Takeda’s now approved Exkivity (mobocertinib) and Cullinan’s CLN-081 have put up impressive results in EGFR exon 20 insertions, the niche where poziotinib failed, but little data exist on exon 20 insertions in Her2. How significant could the latter opportunity be? The sellside once expected poziotinib to sell over $500m by 2024, according to Evaluate Pharma, but now its 2026 consensus is $285m. The late-breaking data will be presented in full on Saturday.

Poziotinib's Zenith20 study in NSCLC (possibly registrational cohorts)
Cohort	Setting	Subjects	Confirmed ORR	mDOR	Result
1	Relapsed, EGFR exon 20 insertions	115	14.8%	7.4mth	Fail: missed undisclosed threshold
2	Relapsed, Her2 exon 20 insertions	90	27.8%	5.1mth	Success: lower bound of CI >17%
3	1st-line EGFR exon 20 insertions	70	27.8%	6.5mth	Fail: lower bound of CI <20%
4	1st-line Her2 exon 20 insertions	70	43.8%*	5.4mth	Apparent success
6	EGFR Tagrisso failures	30	–		–
7	Atypical EGFR or Her mutations	30	–		–
Source: Spectrum & Esmo. Note: *data from 48 evaluable subjects, with a further 2 CRs taking unconfirmed ORR to 48%; ORR=overall remission rate; mDOR=median duration of response; CI=confidence interval. https://www.evaluate.com/vantage/articles/news/snippets/esmo-2021-poziotinib-could-add-first-line-string-its-bow

Esmo 2021 – look out Agenus, Keytruda is about to put up a roadblock

 Merck & Co’s Keytruda is the only anti-PD-(L)1 drug with a cervical cancer label, and it could move from second to first-line use, suggests a just unveiled Esmo late-breaking abstract on the Keynote-826 study. The full data are crucial to Agenus, which is seeking approval for its own anti-PD-1, balstilimab, in second-line cervical cancer, based only on remission rates in an uncontrolled trial that the FDA is due to review by a December 16 action date. In Keynote-826 Keytruda plus chemo beat chemo in terms of overall and progression-free survival in all-comers, and in PD-L1≥1% and PD-L1≥10% expressers, though the abstract does not split out survival for PD-L1 non-expressers. One quirk of this trial is that it also allowed Avastin in both cohorts, with no stratification, but the abstract states that Keytruda’s benefit was seen regardless of the Roche drug. Keynote-826 should see Keytruda approved front line as well as confirming its second-line accelerated green light. Will the FDA nod balstilimab through on an accelerated basis at a time when there could already be a marketed competitor boasting formal approval backed by a survival benefit? This is the daunting question Agenus will likely face.

Anti-PD-1 MAbs in cervical cancer
Project	Setting	Trial	Data	2026e cervical cancer sales
Keytruda (Merck & Co)	2nd-line	Keynote-158 cohort E	14% ORR (9 PRs, 2 CRs)	$94m*
	1st-line (chemo combo, +/- Avastin)	Keynote-826 (all-comers)	mOS 22.4 vs 16.5 mth (HR=0.67, p<0.001); mPFS 10.4 vs 8.2 mth (HR=0.65, p<0.001)
		Keynote-826 (PD-L1 ≥1%)	mOS NR vs 16.3 mth (HR=0.64, p<0.001); mPFS 10.4 vs 8.2 mth (HR=0.62, p<0.001)
		Keynote-826 (PD-L1 ≥10%)	mOS NR vs 16.4 mth (HR=0.61, p=0.001); mPFS 10.4 vs 8.1 mth (HR=0.58, p<0.001)
Balstilimab (Agenus)	2nd-line	NCT03495882	14% ORR (24 PRs, 3 CRs)	$143m^
Note: *out of a total $27.0bn; ^100% of 2026 forecast. Source: Esmo, Evaluate Pharma & prescribing information. https://www.evaluate.com/vantage/articles/news/snippets/esmo-2021-look-out-agenus-keytruda-about-put-roadblock

Almost 1/4 Of COVID Patients In England Being Treated For Something Else

 Authored by Paul Joseph Watson via Summit News,

Almost a quarter of people in hospitals in England who are being counted as ‘COVID patients’ are actually being treated for other illnesses, according to a new report.

“Health service statistics show there were 6,146 NHS beds taken up by people who were Covid positive on September 14th, the latest date data is available for,” reports the Daily Mail.

“But just 4,721 patients (77%) were primarily being treated for the virus, with the remaining 1,425 receiving care for other illnesses or injuries. They could include patients who’ve had a fall or even new mothers who tested positive after giving birth.”

In the Midlands area meanwhile, a full third of patients supposedly being treated for COVID were actually in hospital for different reasons.

The report also acknowledges that as many of half of patients who enter hospital only test positive for COVID after being admitted for an unrelated illness.

The difference between the ‘official’ figure and the real one is important because the UK government has said it won’t hesitate to re-enforce mask mandates, vaccine passports and a new lockdown this winter if hospitalizations continue to rise.

As we previously highlighted, despite the fact that the vaccine was supposed to prevent hospitalizations, many of the same experts who lobbied for the previous lockdowns are claiming that numbers are on a trajectory that will mandate new lockdown restrictions.

Just 24 hours after health secretary Sajid Javid asserted that they had been completely scrapped, the government reversed its position, saying that vaccine passports will in fact form a “first-line defence” against a winter wave of coronavirus.

Back in December, the same government told the public that there was no plan whatsoever to introduce vaccine passports even as they were paying private corporations to build the system.

https://www.zerohedge.com/covid-19/almost-quarter-covid-patients-england-are-being-treated-something-else

Amid COVID surge, states that cut benefits still see no hiring boost

 

The August slowdown in U.S. job creation hit harder in states that pulled the plug early on enhanced federal unemployment benefits, places where an intense summertime surge of coronavirus cases may have held back the hoped-for job growth.

New state-level data released Friday by the Bureau of Labor Statistics showed the group of mostly Republican led states that dropped a $300 weekly unemployment benefit over the summer added jobs in August at less than half the pace of states that retained the benefits.

Elected leaders in those states argued the payments, in place since spring of 2020 to help families through the pandemic, were discouraging people from work and holding back an economic recovery that seemed to be gathering steam earlier this year when the impact of vaccines was taking hold and coronavirus cases were falling.

But some of those same states, notably Florida and Texas, are also hotbeds of opposition to government health mandates like mask wearing, and the surge of infections there in July and August appeared to dent hiring across the sorts of "close contact" businesses that have suffered most during the health crisis and had begun to recover quickly.

Overall employment in the leisure and hospitality fell about 0.5% in the 26 states that ended benefits, and rose 1% elsewhere.

In Florida, where the weekly average of new cases per 100,000 residents jumped from less than 50 in June to more than 700 in August, employment in the sector declined by 4,000 after rising steadily this year.

In Texas, where new infections per 100,000 hit a low of fewer than 30 in June only to surge above 400 through August, the sector dropped 25,000 jobs after six months of steady growth. Georgia, which also saw a dramatic rise in infections, lost nearly 7,000 jobs in the sector.

By contrast California and New York, where the outbreaks driven by the coronavirus Delta variant have been more muted and health controls have tended to be more strict, added around 33,000 and 7,000 jobs in the sector respectively.

The data feed into a debate about how the end of pandemic unemployment benefits will impact the economy - whether it will motivate people to take jobs or leave them strapped for cash amid a new viral wave and difficulties with issues like finding child care.

The benefits ended nationally in early September, and some economists have noted that the hand off from those public payments to private income may not come fast enough to avoid a hit to the overall economy.

While the Delta variant wave of infections may be peaking, the economy's weak August job growth of just 235,000 was viewed by many analysts as evidence of the risks the pandemic still poses to the recovery.

Economists analyzing the unemployment issue have seen little evidence yet that cutting off the benefits has provided a clear boost to local labor markets, in part because of difficulties separating the influence of the payments from larger shifts in the labor force, or of the potentially offsetting damage done by the pandemic.

Goldman Sachs analysts, looking at individual level data, have found that the end of the payments did increase the probability of someone moving from unemployment to a job, and expect the national expiration of the extra unemployment insurance to lead to the addition of an extra 1.3 million jobs by the end of the year.

"The behavioral response to UI-benefit expiration remains highly uncertain due to the unprecedented size of the benefit swings and the highly unusual economic and health situation," Goldman economist Joseph Briggs wrote on Friday.

https://www.marketscreener.com/news/latest/Amid-COVID-surge-states-that-cut-benefits-still-see-no-hiring-boost--36455561/

Biden order would let feds require quarantine for measles cases

 The Biden administration on Friday added measles to the list of quarantinable diseases following a small outbreak of the disease among recent arrivals from Afghanistan.  

The executive order adds measles to the list of diseases for which Health and Human Services and the Centers for Disease Control and Prevention (CDC) have the authority to issue federal quarantine orders, requiring individuals who have been diagnosed with or exposed to measles to self-isolate to protect public health.  

“This action was taken at the request of public health officials, who cited the cases of measles among Afghans who recently arrived in the U.S. as well as several previous outbreaks of measles in recent years,” a White House spokesperson told The Hill by email. 

The Biden administration recently suspended flights bringing Afghan evacuees currently housed in military bases abroad following six confirmed cases of measles.

A measles vaccine was already required upon landing but amid the pause on flights the Department of Defense has begun administering the measles vaccine abroad, waiting to resume flights until everyone is fully inoculated.

The executive order would have ramifications beyond the resumption of flights, giving the government the power to compel quarantine for a disease that has seen an uptick in recent years amid broader vaccine hesitancy.  

Measles cases jumped to 1,282 cases in 2019, the greatest number of cases reported in the U.S. since 1992, according to the CDC. 

“The majority of cases were among people who were not vaccinated against measles. Measles is more likely to spread and cause outbreaks in U.S. communities where groups of people are unvaccinated,” the CDC noted. 

The move follows efforts by the Biden administration to combat vaccine hesitancy for COVID-19, requiring employers with more than 100 workers to mandate vaccination in the workplace or weekly testing.

https://thehill.com/policy/national-security/572812-biden-order-would-allow-government-to-require-quarantine-for-measles

White House to host global COVID-19 summit next week

 The White House announced Friday that it will host a global COVID-19 summit next week, as it seeks to step up efforts to vaccinate the world.

The virtual summit, to be held on Wednesday, coincides with the U.N. General Assembly.

The Washington Post reported Friday that the Biden administration is planning to buy hundreds of millions more doses of vaccine to donate to the world as well, though details have not been announced yet.

The U.S. could also seek to boost commitments from other countries at the summit.

White House press secretary Jen Psaki said in a statement that the U.S. would be calling for a "higher level of ambition" from participants on a range of topics, such as efforts to "vaccinate the world."

Other goals include boosting supplies like oxygen and protective equipment, and aligning the world around targets for getting out of the pandemic.

The moves come as the White House has been under pressure to do more to increase the global vaccination rate.

The White House has pointed to the 140 million vaccine doses it has already donated, and its previous announcement of over 500 million doses to be donated across this year and next. But experts have also called for ramping up global vaccine manufacturing to produce more doses.

Rep. Raja Krishnamoorthi (D-Ill.) praised the reports of more dose donations on Friday, but called on the Biden administration to do more.

"This is undoubtedly a step in the right direction, but I urge the President to take bolder action as soon as possible," Krishnamoorthi said in a statement.

"We need to be talking about billions of vaccines, not millions, and we need those vaccines today, not 6 months from now," he added.

Krishnamoorthi said he looked forward to hearing more details at next week's summit.

https://thehill.com/policy/healthcare/public-global-health/572811-white-house-to-host-global-covid-19-summit-next-week

Exelixis Announces FDA Approval of CABOMETYX for thyroid cancer

 – FDA approval based on phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with CABOMETYX versus placebo –

– Exelixis is prepared to fully support expanded indication immediately –

– Application approved well ahead of Prescription Drug User Fee Act target action date of December 4, 2021 –

https://www.biospace.com/article/releases/exelixis-announces-u-s-fda-approval-of-cabometyx-cabozantinib-for-patients-with-previously-treated-radioactive-iodine-refractory-differentiated-thyroid-cancer/