#AACR17 roundup: Bris­tol-My­ers, Mer­ck KGaA and Pfiz­er in the spot­light, mark­ing progress with check­points

PHO­TO: © AACR/Todd Buchanan 2017

Julie Brah­mer, Johns Hop­kins
Bris­tol-My­ers IDs a sub­set of pa­tients who see a durable, 5-year re­sponse to Op­di­vo

Wash­ing­ton, DC — Now that the first wave of PD-1 check­point in­hibitors have been in use for awhile, we’re start­ing to see just how durable they can be for some pa­tients. In an up­date on Op­di­vo at AACR, Bris­tol-My­ers Squibb re­ports that they tracked a 5-year sur­vival rate of 16% for pa­tients with ad­vanced cas­es of non-small cell lung can­cer.

Based on his­tor­i­cal da­ta, Bris­tol-My­ers says that pa­tients in that cat­e­go­ry once could on­ly ex­pect a sur­vival rate of less than 5%.

“This is the first re­port of the long-term sur­vival rate in pa­tients with metasta­t­ic NSCLC treat­ed with an im­mune check­point in­hibitor. Our study re­sults show that for a small sub­set of pa­tients, im­munother­a­py can work for a very long time,” said Julie Brah­mer, as­so­ciate pro­fes­sor of on­col­o­gy at the Bloomberg~Kim­mel In­sti­tute for Can­cer Im­munother­a­py at Johns Hop­kins.

Fouad Namouni, Bris­tol-My­ers Squibb

What dis­tin­guish­es these pa­tients?

Bris­tol-My­ers Squibb’s Fouad Namouni, who runs the on­col­o­gy de­vel­op­ment group, tells me that they’re still work­ing on that, try­ing to un­der­stand the bio­mark­ers that could flag which pa­tients are most like­ly to get the most durable re­spons­es. One like­ly an­swer, he notes, is that the pa­tients with the most in­flam­ma­to­ry tu­mors, with the largest mu­ta­tion bur­den, could be ben­e­fit­ing dis­pro­por­tion­ate­ly.

More mu­ta­tions, he says, means that the tu­mors be­come “more vis­i­ble to the im­mune cell,” tar­get­ing them for de­struc­tion.

Pfiz­er, Mer­ck KGaA spruce up Baven­cio’s pro­file with a da­ta up­date
Howard Kauf­man, Rut­gers

Mer­ck KGaA and its part­ner Pfiz­er turned up at AACR over the week­end with some im­proved out­comes for their check­point drug avelum­ab, re­cent­ly ap­proved as Baven­cio for rare cas­es of Merkel cell car­ci­no­ma.

Ev­i­dence of a slight­ly amped up and more durable re­sponse will help these new ar­rivals on the check­point scene make quick progress as it works its way in­to an in­creas­ing­ly crowd­ed field. Start­ing with this rare form of skin can­cer, they now have 30 tri­als un­der­way in var­i­ous in­di­ca­tions, com­ing in be­hind Mer­ck, Bris­tol-My­ers and Roche.

As­traZeneca will be the next to ar­rive, as it leaps in­to a block­buster field with dur­val­um­ab. And be­hind As­traZeneca lie a whole new wave of check­points that are be­ing hur­ried along, as the pi­o­neers start a slew of com­bi­na­tion stud­ies — as our lat­est sto­ry on the IDO1 com­bos in­di­cate — to ad­vance their work.

The re­searchers for these two com­pa­nies re­port­ed that:

(A)fter longer fol­low-up, the num­ber of pa­tients to have a re­sponse in­creased to 29, for an over­all re­sponse rate of 33 per­cent af­ter a me­di­an of 16.4 months of fol­low-up. In ad­di­tion, the num­ber of pa­tients to have a com­plete re­sponse in­creased to 10 be­cause one of the par­tial re­spons­es had im­proved to a com­plete re­sponse, and an­oth­er pa­tient new­ly record­ed to have a re­sponse had a com­plete re­sponse.

At the time of da­ta cut­off, 21 of the re­spons­es were on­go­ing and the me­di­an du­ra­tion of re­sponse had not been reached. The re­searchers es­ti­mat­ed that 74 per­cent of pa­tients will have a re­sponse that lasts one year or longer.

Mer­ck KGaA sped through clin­i­cal tri­als in three-and-a-half years to get this first ap­proval, a mile­stone that Pfiz­er helped make hap­pen with a record $850 mil­lion up­front for its part­ner­ship arrange­ment with the Ger­man Mer­ck, which has gone well over a decade with­out a block­buster ad­di­tion from its R&D ops.

Howard Kauf­man, a sur­gi­cal on­col­o­gist at Rut­gers Can­cer In­sti­tute of New Jer­sey, not­ed:

The find­ings of long-term re­spons­es and well-tol­er­at­ed safe­ty pro­file sug­gest that avelum­ab could be an im­por­tant new agent for pa­tients with Merkel cell car­ci­no­ma who have failed pri­or chemother­a­py. Giv­en these re­sults, it will be in­ter­est­ing to de­ter­mine whether re­sponse rates could be in­creased by giv­ing avelum­ab pri­or to chemother­a­py or in com­bi­na­tion with oth­er treat­ments.

Op­di­vo, Yer­voy com­bo scores high­er sur­vival rate for melanoma, with worse ad­verse events

Bris­tol-My­ers, which has been work­ing on bol­ster­ing its case for a com­bi­na­tion of Op­di­vo and Yer­voy in treat­ing can­cer, al­so turned up at AACR with new da­ta that high­lights im­proved sur­vival rates for melanoma rates.

James Larkin, On­col­o­gist

On­col­o­gist James Larkin and col­leagues en­rolled 945 first-line pa­tients with ad­vanced melanoma and ran­dom­ly as­signed them in equal groups to nivolum­ab plus ip­il­i­mum­ab, nivolum­ab, or ip­il­i­mum­ab.

Af­ter a min­i­mum fol­low-up of 28 months, in­ves­ti­ga­tors re­port­ed, me­di­an over­all sur­vival among those pa­tients ran­dom­ly as­signed ip­il­i­mum­ab was 20 months. The me­di­an OS had not been reached for the nivolum­ab plus ip­il­i­mum­ab or the nivolum­ab plus place­bo arms.

A to­tal of 64% in the com­bo arm achieved two-year sur­vival, the high­est rate. The rate was 59% and 45% among those ran­dom­ly as­signed nivolum­ab plus place­bo and ip­il­i­mum­ab alone. But the com­bo arm al­so ex­pe­ri­enced worse ad­verse events.

Re­searchers added:

A sim­i­lar trend was seen for me­di­an du­ra­tion of re­sponse. Me­di­an du­ra­tion of re­sponse had not been reached in the nivolum­ab plus ip­il­i­mum­ab arm, while it was 31.1 months and 18.2 months for the nivolum­ab plus place­bo arm and ip­il­i­mum­ab alone arm, re­spec­tive­ly. In de­scrip­tive analy­ses, mean­ing the study was not pow­ered for this com­par­i­son, pa­tients ran­dom­ly as­signed nivolum­ab plus ip­il­i­mum­ab had a 12 per­cent low­er risk of death com­pared with those ran­dom­ly as­signed nivolum­ab plus place­bo.

“It is ex­cit­ing to see that ini­tial re­sults sug­gest that the nivolum­ab plus ip­il­i­mum­ab com­bi­na­tion pro­vides fa­vor­able sur­vival out­comes com­pared with ip­il­i­mum­ab alone,” said Larkin. “How­ev­er, the com­bi­na­tion al­so re­sults in a high­er rate of se­vere ad­verse events than nivolum­ab or ip­il­i­mum­ab alone, so it is im­por­tant to con­sid­er this when mak­ing treat­ment de­ci­sions for pa­tients.”

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.