Mer­ck high­lights cru­cial hit for Keytru­da in sec­ond-line esophageal car­ci­no­ma — but there are al­so 2 miss­es

Mer­ck has un­veiled a Phase III da­ta pack­age back­ing Keytru­da’s case as a sec­ond-line treat­ment for the tough in­di­ca­tions of esophageal and esoph­a­gogas­tric junc­tion car­ci­no­ma, un­der­scor­ing its ear­li­er con­fi­dence that the PD-1 in­hibitor rep­re­sents a sig­nif­i­cant ad­vance in this field de­spite on­ly hit­ting one of three pri­ma­ry end­points.

The key num­ber the com­pa­ny wants to fo­cus on is 31% — the de­gree by which Keytru­da re­duced the risk of death com­pared to chemother­a­py in pa­tients with squa­mous cell car­ci­no­ma or ade­no­car­ci­no­ma, who had pro­gressed af­ter stan­dard ther­a­py and whose tu­mors ex­pressed PD-L1 (as quan­ti­fied by a com­bined pos­i­tive score, or CPS, of 10 or above).

That sub­group, which con­sti­tutes 222 out of 628 to­tal pa­tients in the KEYNOTE-181 study, reached a me­di­an OS of 9.3 months ver­sus 6.7 months for the chemo group. They al­so had a 12-month OS rate of 43% while the chemo arm ex­pe­ri­enced 20%.

These are pa­tients whose can­cer — in the esoph­a­gus or the esoph­a­gogas­tric junc­tion — pro­gressed af­ter ini­tial treat­ment, fol­low­ing a poor prog­no­sis to be­gin with, re­searchers added.

For the en­tire in­ten­tion-to-treat pop­u­la­tion, though, the dif­fer­ence in OS be­tween two arms was not sta­tis­ti­cal­ly sig­nif­i­cant with a me­di­an OS of 7.1 months for both treat­ment groups. Same goes for the oth­er sub­group an­a­lyzed for the study — the 401 pa­tients with squa­mous cell car­ci­no­ma — with the Keytru­da group see­ing a me­di­an OS of 8.2 months com­pared to 7.1 months in those re­ceiv­ing chemo.

These fail­ures kept in­ves­ti­ga­tors from for­mal­ly test­ing the sec­ondary end­points, mean­ing that we won’t know the pro­gres­sion-free sur­vival and ob­jec­tive re­sponse rate.

Mean­while, a sep­a­rate Phase III study — dubbed KEYNOTE-590 — is putting the block­buster check­point in­hibitor to first-line use in com­bi­na­tion with chemother­a­py for pa­tients with esophageal car­ci­no­ma.

Ri­vals are lin­ing up their own shots at esophageal and esoph­a­gogas­tric can­cers, with late-stage of­fer­ings from chief ri­val Bris­tol-My­ers Squibb. Cel­gene and BeiGene, which were slat­ed to notch the 7th PD-1 ap­proval in the US, were al­so in the game, though the pro­gram’s fate re­mains un­clear as Bris­tol-My­ers com­pletes its $74 bil­lion ac­qui­si­tion of Cel­gene.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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