announced the publication of an abstract for a poster presentation of early clinical data on the bispecific antibody petosemtamab in advanced gastric/esophageal adenocarcinoma (GEA) at the American Association for Cancer Research (AACR) Annual Meeting.
The company has decided to pause further clinical exploration of the GEA cancer cohort.
Petosemtamab has demonstrated promising clinical activity among pretreated gastric/esophageal adenocarcinoma (GEA) patients, Merus said.
Given the strong clinical activity observed in this cohort, the company plans to prioritize investigating petosemtamab in head and neck squamous cell carcinoma.
As of an October 24, 2022, data cutoff date, 14 previously treated GEA patients were treated with petosemtamab 1500 mg (IV) every two weeks.
One patient with tumor epidermal growth factor receptor protein overexpression and gene copy number amplification showed a confirmed sustained partial response (67% tumor reduction; response ongoing after 24 cycles).
Three patients had stable disease, with 2%, 17%, and 40% tumor reductions.
The company also published the first look at updated data from the dose-expansion portion of Phase 1/2 study of petosemtamab in patients with head and neck squamous cell carcinoma (HNSCC).
As of the data cutoff in the abstract of November 28, 2022, 42 patients were evaluable for response, with an ORR of 35.7% reported (15/42), including one complete response (CR) and two unconfirmed partial responses (uPRs, treatment ongoing).
15 patients had stable disease and a disease control rate of 71.4%
The median duration of response at the cutoff was six months, and the median progression-free survival was 5.0 months.
William Blair writes that the response rate comes in well above double the rate of monotherapy response rate (13%) observed with Eli Lilly And Co's
Last year, we discussed the declaration of WHO Director-General Tedros Adhanom Ghebreyesus that censorship was needed to combat what he called the “infodemic.” It was a jarring position given the censorship of experts and scientists who have now been vindicated in raising questions over mask protection to natural immunities to school closings to the origins of Covid 19. Nevertheless, U.S. Food and Drug Administration Commissioner Robert Califf added his own voice to call for censorship. Califf declared that life expectancy rates are being suppressed due to “misinformation.” His call for action against ill-defined “disinformation” or “misinformation” is being echoed throughout the Biden Administration.
In a CNBC interview, Califf lashed out at “health misinformation” which he said was one of his top priorities to address through “specific authorities at FDA, FTC and other areas.”
Califf noted:
“You think about the impact of a single person reaching a billion people on the internet all over the world, we just weren’t prepared for that. We don’t have societal rules that are adjudicating it quite right, and I think it’s impacting our health in very detrimental ways.”
He does not elaborate on what would be those “societal rules” for “adjudication” of access to information. However, it holds a familiar ring for free speech advocates.
In recent months, the Twitter Files revealed an extensive and secret effort by the FBI and other agencies to censor citizens on social media. I testified on that effort. New emails uncovered in the ongoing Missouri v. Biden litigation reportedly show that the Biden Administration’s censorship efforts extended to Facebook to censor private communications on its WhatsApp messaging service.
As officials like Califf call for continued crackdowns, there is no recognition of how the government worked to silence opposing views that have been vindicated in recent months.
For years, scientists faced censorship for even raising the lab theory as a possible explanation for the virus. Their reputations and careers were shredded by a media flash mob. The Washington Post declared this a “debunked” coronavirus “conspiracy theory.” The New York Times’ Science and Health reporter Apoorva Mandavilli was calling any mention of the lab theory “racist.”
When a Chinese researcher told Fox News that this was man-made, the network was attacked and the left-leaning PolitiFact slammed her a “pants on fire rating.”
The mask mandate and other pandemic measures like the closing of schools are now cited as fueling emotional and developmental problems in children. The closing of schools and businesses was challenged by some critics as unnecessary. Many of those critics were also censored. It now appears that they may have been right. Many countries did not close schools and did not experience increases in Covid. However, we are now facing alarming drops in testing scores and alarming rises in medical illness among the young.
The point is only that there were countervailing indicators on mask efficacy and a basis to question the mandates. Yet, there was no real debate because of the censorship supported by many Democratic leaders in social media. To question such mandates was declared a public health threat and what the WHO called our “infodemic.”
A lawsuit was filed by Missouri and Louisiana and joined by leading experts, including Drs. Jayanta Bhattacharya (Stanford University) and Martin Kulldorff (Harvard University). Bhattacharya previously objected to the suspension of Dr. Clare Craig after she raised concerns about Pfizer trial documents. Those doctors were the co-authors of the Great Barrington Declaration, which advocated for a more focused Covid response that targeted the most vulnerable population rather than widespread lockdowns and mandates. Many are now questioning the efficacy and cost of the massive lockdown as well as the real value of masks or the rejection of natural immunities as an alternative to vaccination. Yet, these experts and others were attacked for such views just a year ago. Some found themselves censored on social media for challenging claims of Dr. Fauci and others.
The media has quietly acknowledged the science questioning mask efficacy and school closures without addressing its own role in attacking those who raised these objections.
What is most striking about Califf’s comments is the failure to address how censorship in the last three years may have increased public health risks by suppressing opposing or dissenting scientific views. Indeed, just this week, a new British study came out directly refuting CDC guidance on masks and suggesting that, while not appreciably reducing the risk of serious Covid symptoms, masks may have caused health problems. Other studies have rejected the mask efficacy argument though this remains a matter of intense debate.
The point is that there is now a debate after social media companies allowed people to discuss these views and the media is no longer labelling dissenters as conspiracists or racists.
Before we continue to make these government efforts a top priority, we should have a public debate over the means used to combat misinformation and what constitutes misinformation. That should start with a full investigation of past government efforts to censor or blacklist individuals or groups.
State health officials want to force hospitals and other medical providersto submit “equity’’ reportsto justify their projects, but critics are bashing the move as another misguided “woke” experiment.
The ground-breaking proposal comes as New York’s Dem pols and health officials have become social-justice warriors, particularly after the COVID-19 crisis, as they implement policies to confront the decades of systemic racism they say is ingrained in the medical system.
“The proposed regulation, which is the result of a law signed in 2021, is just the latest example of how New York State and the Department of Health are working to end systemic inequities that have led to measurable health disparities for traditionally underserved populations across the state,” New York Health Department spokesman Cort Ruddy said in a statement.
The planned rule would require medical entities to conduct an independent “health equity assessment” when applying to open any new facility or slash or consolidate existing services in neighborhoods.
State health officials say the assessments will determine the impact on care to underserved New Yorkers: residents who are poor, racial and ethnic minorities, immigrants, people with disabilities and the elderly.
The assessment would be required to land a “certificate of need’’ from state health regulators.
“The purpose of the health equity impact assessment is to demonstrate how a proposed project affects the accessibility and delivery of health care services to enhance health equity and contribute to mitigating health disparities in the facility’s service area, specifically for medically underserved groups,” the planned new regulation states.
But critics including state Conservative Party Chairman Gerard Kassar — who served on a Brooklyn hospital board and is familiar with the application process — are slamming the proposed new rules as redundant and counterproductive.
“The Democrats and the progressive are creating tyrannies that don’t exist — it defies logic,” Kassar said of the plan.
“The current review process takes the community’s needs into account. The racial aspect has always been taken into account.
“The application process should be based on medical need. Instead, they are turning hospitals into social-service experiments.’’
A Health Department spokesman said the proposed rule is about “working to end systemic inequities” in the healthcare system.Richard Drew / AP
The medical providers would be required to fork out bucks to hire a private firm to conduct the assessments — although regulators suggest the costs are negligible.
“The projected costs associated with performing such an assessment are not easily identifiable, as they will vary greatly depending on the size, scope and complexity of a facility’s proposed project,’’ the proposal states.
“However, the Department anticipates these costs could range anywhere from $500 to upwards of $30,000. These costs are unavoidable in the regulations, as [the law] requires health equity impact assessments to be performed by independent entities.”
The proposed rules, published in the State Register, will now undergo a 60-day public comment period followed by agency review before being considered for final adoption, the Health Department said.
“For far too long, communities of color in New York have been held back by systemic racism and inequitable treatment,” Hochul said in December 2021.
The New York City Board of Health also declared racism a public-health crisis in October of 2021, citing America’s history of slavery and the devastating outcomes for minorities during the coronavirus outbreak.
That resolution called for the city Health Department to implement policies to address racism in its own research and policies, including “a racially just recovery from COVID-19, as well as other actions to address this public health crisis in the short and long term.”
For example, New York City health officials took a patient’s race into account during the pandemic when distributing potentially life-saving COVID treatments.
The new state equity assessment rules would cover hospitals, nursing homes, clinics, diagnostic treatment centers and other health facilities seeking state regulatory approvals for proposed mergers, acquisitions, closings, downsizing, new construction or change of ownership.
