Merck Is Certain To Win FDA Approval By Next Monday, For Keytruda, In Neoadjuvant and Adjuvant Resectable Non-Small Cell Lung Cancer.

This was widely expected, given the fine interim results Rahway earlier posted, in KEYNOTE-671.

Now we have a likely approval date, from FDA — October 16, 2023. Again, the pembrolizumab freight train just keeps rolling on — out, into the night… seemingly… forever. Here’s the news:

…Merck announced today that its anti-PD-1 therapy Keytruda reached the dual primary endpoint of overall survival (OS) in a Phase 3 trial designed to test it as a neoadjuvant and adjuvant option for resectable non-small cell lung cancer (NSCLC).

In a previous interim analysis, the trial known as KEYNOTE-671 of 786 patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC met the other dual primary endpoint of event-free survival (EFS) and key secondary endpoints.

KEYNOTE-671 “represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA, or IIIB (T3-4N2) non-small cell lung cancer,” Dr. Marjorie Green, MRK’s head of late-stage oncology, said.

According to the company, Keytruda plus chemotherapy before surgery (neoadjuvant) and as a single agent after surgery (adjuvant) indicated a statistically significant and clinically meaningful improvement in OS against the comparator….

Now you know — getting to excited to see “Hamilton” again tomorrow. Grin….

नमस्ते

Mr. Biden’s New Rule — Helping Law Enforcement Stop Felons From Obtaining “Ghost” Guns (And Track Them To The Makers) — Is Headed To The Supremes, Again…

The NRA-allied forces have only until this Wednesday at 5 pm, to oppose. And by mid next week, we expect the Supremes will have formally agreed to take the case. It simply cannot be that felons nationwide may order, in secret, entirely untraceable ghost gun kits. That is just… lunacy. NRA driven… lunacy.

To get you educated on the important contours of this case out of Texas (one we’ve not covered here before) — here is a bit of the well-argued amicus brief, from a passel of sane state attorneys’ general:

…Recent advances in firearms technology have prompted the Bureau of Alcohol, Tobacco, Firearms and Explosives (“ATF”) to reexamine its rules implementing the GCA. In the past few years, the ghost gun industry has exploded, driven in large part by the online sale of weapon parts kits. These user-friendly kits typically contain nearly complete firearms parts and require a minor amount of assembly to become fully functional weapons. 87 Fed. Reg. at 24662. As these firearms kits have proliferated, so too have self-made, unserialized guns. Law enforcement officers went from recovering about 1,700 self-made guns in 2016 to over 19,000 in 2021, an eleven-fold increase. Id. at 24656. Altogether, officers recovered about 45,240 self-made guns during that five-year period — more than 40 percent of which were recovered in 2021 alone. Id. at 24656.

The rise of these kits revealed two problems. First, a person explicitly banned from firearm possession under the GCA could buy a kit and assemble a fully functional gun within hours. Second, because the finished product was unserialized, officers could not track the gun if it was later used in a crime. Indeed, of the 45,240 suspected ghost guns recovered from 2016 to 2021, only 445 could be traced — a less than one percent success rate….

[Mr. Biden’s] Final Rule is a vital backstop to states’ efforts to stem the flow of ghost guns and combat the violence engendered by prohibited persons possessing untraceable weapons. In response to the recent influx of ghost guns, at least 14 jurisdictions have enacted their own laws regulating weapon parts kits and partially complete frames or receivers. But absent federal enforcement, the number of unserialized guns has proliferated, leaving in its wake a spike in crime and violence. The Final Rule serves a vital coordinating function, consistent with the GCA, that states cannot exercise on their own….

Is anyone here even remotely… surprised, that this lunacy… is a creature of local Texas law?!

And yes, this item belongs here, as ghost guns are an emerging national public health crisis — just as the proliferation of bump-stock enabled, semi-automatic weapons… has been for decades, in the US. Onward — to a matinee of “Hamilton” (again!) on Wednesday, with my eldest daughter (who, because she’s spent almost all of the last five years outside of the US, has yet to see it, live). Woot!

नमस्ते

We Are About To Find Out If Hinderaker Has The Stomach — For His Own Rhetorical Flourishes.

He repeatedly called for an all out war — to eradicate all Palestinians now living in Gaza.

In the last 36 hours, Israel began targeting civilian facilities in Gaza without prior warnings of any kind. This is precisely what Hinderaker called for. And yes, war is… hell.

Now, Hamas has announced any additional targeting of civilians in Gaza (without a few hours’ advance warning) will result in televised executions of Israeli hostages (many of them very young people who were concert-goers, just before all hell broke loose).

I guess we will find out whether Hinderaker is made of as stern stuff… as he claims to be.

This is what happens when doddering, embittered, mediocre whyte guys… run their big mouths.

Charming, a-hole.

Out.

YAWN. There’s Going To Be A LOT Of Feckless, Opportunistic Lying — About Hamas / Gaza Now…

And the four demonic creatures imaged at right are likely to be among the most prolific of the… liars.

Drawing cause / effect conclusions where none are reasonably inferential. Directly blaming the current Administration for the policy failures of the last half-century, in that part of the globe. That sort of nonsense.

To be certain, the attack is heinous. War… is heinous.

But vainly trying to make this the fault of US Democratic party leaders… is simply… insane.

I will not try to refute each one, seriatum — just take this a blanket demurral.

They are all… opportunistic liars — bent on driving supposed wedge issues (for 2024 political / fund-raising agendas), not solving world problems — in this case, ones that have festered for… three thousand years.

[U] “Psyche” Mission Now Cleared For A Thursday Liftoff — From Kennedy Space Center.

We’ve been following this upcoming mission since 2021. With all pre-launch issues now well-resolved… NASA is touting this slightly-delayed trip, to a metal rich asteroid that may have been, about 3 million years ago, the core of a planetesimal — stripped, by a series of collisions.

Here are all those latest details, from NASA:

…NASA is inviting the public to take part in virtual activities ahead of the launch of NASA’s Psyche spacecraft. The Psyche spacecraft will travel about 2.2 billion miles to study a metal-rich asteroid of the same name. The asteroid, which lies in the outer portion of the main asteroid belt between Mars and Jupiter, may be part of a core of a planetesimal (a building block of a planet) and can tell us more about planetary cores and Earth’s own formation.

Psyche is targeting liftoff at 10:16 a.m. EDT on Thursday, Oct. 12, on a SpaceX Falcon Heavy rocket from Launch Complex 39A at the agency’s Kennedy Space Center in Florida. The spacecraft also is hosting a technology demonstration, NASA’s Deep Space Optical Communications (DSOC), which will be the first test of laser communications beyond the Moon….

To be certain, as the above graphic indicates, this is a long term cruise (2929-ish or so) just to get into position to do the science. But well worth Seamus Heany’s “commanded journey“, indeed. Now you know… grinning into a fine Sunday afternoon — heading to town art fairs, with my baby girl… smile.

नमस्ते

Now Come… The Feckless Liars, And Opportunists — Regarding Israel / Gaza / Hamas.

Seriously, Paul?

I get that your faith in Israeli’s intel methods is badly shaken here. It ought to be.

But trying to make any of this Mr. Biden’s fault is… churlish, beyond words.

Remind me: did you even blame Putin — for his direct aggression in Ukraine?

Crickets.

Did you blame… Trump?

Again — negative, even for sightings, of crickets.

Yet Mr. Biden was (we are left to assume) supposed to commit US troops to eliminate Hamas (something Tangerine unequivocally would never have done!) in that part of the world, while you yourself, and the Powerline boys preach an isolationist mantra, in all other matters in that part of the world?

C’mon man — this is a horrific act of war. But it is plainly over lands disputed for two millennia or more.

That doesn’t excuse it — but if you are willing to blame Mr. Biden… why didn’t your boy Tangerine do something about it — with all his supposedly-tight ties to Israel, 2016-21?

Just give that nonsense a rest.

Supremes Hear From US Agencies — On How Befuddled The Trial Court, And The Fifth Cir. Are, On What Private Platforms “May Be… Required To Carry”.

In truth, the whole of this discussion has been turned on its head, by the largely clue-free USDC Judge Doughty in Monroe, Louisiana. What he claims is government “censoring” — is in fact, by his opinion — a rule that would purport to order private social media platforms (on pain of contempt) to carry false information (including life threateningly false health information), defamatory material, and racial, gender and ethnic invective that has no place in a private living room. And make no mistake — these are private living rooms… no one must tolerate miscreants in their virtual homes.

But, even taking it the way he framed it — the federal government agencies will prevail. They have every right to lobby and encourage private actors to avoid public health disasters (among other things). And so, the feds have filed a supplemental memorandum before the Supremes here at week’s end, to make this plain(er). Here are the the whole nine-well argued pages, and a bit:

…In short, the amended decision relies on the same flawed conception of the state-action doctrine to extend injunctive relief to another set of government defendants. In extending the injunction, the decision vividly illustrates the expansive and malleable nature of the Fifth Circuit’s novel test for state action, underscoring both the court’s errors on the merits and the grave harms imposed by an injunction requiring thousands of government employees to adhere to the Fifth Circuit’s standard on pain of contempt….

Indeed, the reinstatement of the injunction with respect to the CISA defendants only further illustrates the Fifth Circuit’s legal errors. The Fifth Circuit relied on its view that CISA supposedly “‘facilitat[ed]’” the “FBI’s interactions with the social-media platforms.” Revised Op. 59. But the court’s rationale with respect to the FBI was that any communication from the FBI is inherently coercive because the FBI is a powerful law enforcement agency, and that the platforms’ acceptance of an FBI recommendation was sufficient to establish “significant encouragement” under the lax “entanglement” standard. See id. at 55-57. The government has explained why those theories lack merit….

And because the FBI’s own conduct did not transform the platforms’ content-moderation decisions into state action, the CISA defendants cannot have engaged in state action merely by facilitating the FBI’s efforts — especially given that CISA itself does not exercise any law-enforcement authority over the platforms….

Onward, smiling — into the Saturday morning’s Fall sunshine… with a crisp breeze afloat.

नमस्ते

Trump Finds That Federal Trials On Felonies Are Not Easily Delayed — Side Of Hamas

So, for two decades — in CIVIL litigation (primarily in state courthouses) — Tangerine’s “delay, delay… delay” strategies… served him well.

In felony cases, in the federal courts? Not. So. Much, now.

The able USDC Judge Tanya S. Chutkan essentially just slapped down all his foot dragging in the 01.06.21 prosecution.

He claims this case will impact his election chances… yet he himself is trying to push it deeper into primary elections timelines.

Actually, his silly and unobtainable goal is to place trial AFTER November 7, 2024. That is never going to happen.

These are serious felonies, and the Speedy Trial Act, among other positive laws, prevent the government from “letting it fester, and twist in the wind”.

So — he has significant deadline dates arriving already, before the end of October 2023. Do take a look. Her opinion is spot on, on the law.

Onward, disgusted that Hamas is doing what it is continuing to do — but also clear that the claims (to the Gaza Strip) have been a source of dispute… for almost all of modern Israel’s existence. [And for a thousand years prior, about two thousand years ago… in truth.]

One other way to understand this… is to see it as just trying to reclaim land Hamas regards as its. I express no opinion about the merits of such a view.

But it is… ironic that the same far right voices that speak of Putin’s right to reclaim Ukraine lands… are notably silent about that supposed “right” — in the Gaza Strip.

That is all. A small point, perhaps, but the disputes along the strip predate the founding of Kiev… they are as old as Western civilization, itself.

Out.

Catch-Up / Power-Alley: This Week, Keynote 123 Posted A [Secondary Endpoint] Win, In Muscle-Invasive Urothelial Carcinoma…

I was detained elsewhere that day, but on Thursday, Merck got more encouraging pembrolizumab news.

Its Keynote 123 study, or “Ambassador” as it has been re-dubbed (are we trademarking study names, now?)… show nice progression free survival durations for Keytruda. Here’s the story, as reported in BioSpace:

…Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma.

Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint….

AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was administered intravenously for up to 18 cycles, while comparators in the observation arm were given no intervention beyond routine clinical procedures including a CT scan, blood analysis and an MRI.

However, Merck’s blockbuster asset has not been without its recent setbacks. Late last month, Keytruda stumbled in two Phase III studies in non-small cell lung cancer when given with Eisai’s Lenvima (lenvatinib). In this indication, the combination regimen failed to significantly boost PFS and OS when given as either a first-line or second-line intervention….

Now you know — and go Buffs, win in the heat down at ASU, tonight (I’ll be peeking in on the score from the Lyric, at intermission). Smile….

नमस्ते

As We Indicated — We Now Await A Redacted Pre-Trial Order Copy, By Joint Submission — But With A Potential 2024 Trial Date… It May Slip To November 2023.

This morning’s court-filed mail in the name spat offers us proof that our concerns are being addressed. Just not as swiftly as would obtain, under Chicago’s local federal rule book. We will be reasonably patient, since it is now clear a trial date cannot feasibly be set before late in 2024 (due to the court’s own quite bustling-and-busy docket).

In any event, it is good to see that the parties are mindful that the fourth estate has a right to see this document in redacted form — as do…”we, the people“. After all, this is certainly a multi-billion dollar bit of federal litigation, involving two premier multinational life science companies:

…Dear Judge Hammer:

We represent Plaintiffs in this matter. Together with counsel for Defendant, we write to request an extension of the time to file redacted copies and a motion to seal associated with the proposed Final Pretrial Order filed on September 25, 2023 (ECF No. 227) and the anticipated Final Pretrial Order that the Court will enter after the Final Pretrial Conference, currently scheduled for November 21, 2023.

Under the local rules, the redacted copy of the proposed Final Pretrial Order and a motion to seal are due on October 10, 2023. The parties are conferring about what portions of this document are confidential and require additional time to discuss redactions. In addition, considering the order that the Court will enter after the Final Pretrial Conference will implicate the identical confidential material, we respectfully request permission to file a consolidated motion to seal to cover both documents two weeks after the Court enters the Final Pretrial Order.

If this request is agreeable to the Court, we respectfully request Your Honor endorse this letter below as “So Ordered” and have it placed on the docket.

We appreciate the Court’s attention to this matter.

Respectfully,

/s/ Cynthia S. Betz
Cynthia S. Betz….

Smiling now — it seems the message was… received. Onward, to opera tomorrow night — and TedTalks, tonight.

नमस्ते