Trou­bled by deaths, FDA or­ders Mer­ck to slam the brakes on three Keytru­da stud­ies

Roger Perl­mut­ter, Mer­ck

A month af­ter Mer­ck flagged a high­er risk of death in two com­bo stud­ies us­ing its flag­ship drug Keytru­da, the FDA has fol­lowed up with a clin­i­cal hold that will slam the brakes on fur­ther treat­ment in three mul­ti­ple myelo­ma tri­als.

Mer­ck said a few weeks ago that it planned to con­tin­ue treat­ment in the two stud­ies – KEYNOTE 183 and KEYNOTE 185 – while paus­ing en­roll­ment of new pa­tients. Those mul­ti­ple myelo­ma tri­als matched Mer­ck’s block­buster ther­a­py with two drugs from Cel­gene, Po­m­a­lyst and its big drug Revlim­id.

The FDA, though, wants pa­tients tak­en off of Keytru­da in the two Phase III stud­ies and al­so or­dered Mer­ck to stop treat­ing pa­tients in KEYNOTE-023 Co­hort 1, match­ing Keytru­da in com­bi­na­tion with lenalido­mide and dex­am­etha­sone in pa­tients who re­ceived pri­or an­ti-mul­ti­ple myelo­ma treat­ment with an im­munomod­u­la­to­ry (IMiD) treat­ment (lenalido­mide, po­ma­lido­mide or thalido­mide).

The lat­est news com­pounds a new headache for Mer­ck just as it was putting some se­ri­ous dis­tance be­tween it­self and Bris­tol-My­ers Squibb’s trou­bled ri­val PD-1 drug Op­di­vo. The phar­ma gi­ant notes that these are the on­ly three tri­als – among dozens in the clin­ic – that are af­fect­ed by the agency’s de­ci­sion. Mer­ck has nev­er of­fered an ex­pla­na­tion, or the­o­ry, about the high­er risk of deaths in these com­bi­na­tion stud­ies.

Mer­ck shares were down about 1% in af­ter-mar­ket trad­ing.

The clin­i­cal hold al­so rais­es ques­tions about some of the oth­er com­bi­na­tion stud­ies in the clin­ic. Ever­core ISI’s Umer Raf­fat notes:

It will be very in­ter­est­ing to see the fate of BMY’s Check­mate-602 (ni­vo + pom/dex) as well as Cel­gene/AZN’s FU­SION­MM-03 of dur­va+dara+pom/dex in mul­ti­ple myelo­ma. Here’s what we know at present:  BMY tri­al was ini­ti­at­ed ~6 months af­ter MRK’s un­suc­cess­ful myelo­ma tri­als … and the Cel­gene/AZN tri­al was ini­ti­at­ed ~9 months af­ter MRK’s

“Pa­tient safe­ty is Mer­ck’s pri­ma­ry con­cern, and we are grate­ful to the study in­ves­ti­ga­tors and pa­tients in­volved in these stud­ies for their com­mit­ment to this im­por­tant re­search,” said Roger Perl­mut­ter, pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries. “Mer­ck’s de­vel­op­ment pro­gram for KEYTRU­DA, span­ning more than 30 dif­fer­ent tu­mor types, has one pri­or­i­ty: help­ing pa­tients suf­fer­ing from can­cer.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Lil­ly's mirik­izum­ab, once a con­tender for pso­ri­a­sis, bol­sters case for UC in­di­ca­tion in main­te­nance tri­al da­ta read­out

Early last year, Eli Lilly announced that instead of taking its blockbuster contender mirikizumab forward to the FDA for psoriasis, it would be essentially going nowhere in the indication. Instead, the pharma then announced in its Q1 ’21 earnings statement that it would be focusing on ulcerative colitis and Crohn’s disease indications in a sudden about-face.

And as the drug is before the FDA for potential approval for the first indication of ulcerative colitis, the megapharma is now ready to reveal more data to bolster its case.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.