Bris­tol My­ers Squibb pulls the cur­tain on PhI­II da­ta to back Op­di­vo in the ad­ju­vant set­ting

In its lat­est at­tempt to out­shine Mer­ck’s Keytru­da, Bris­tol My­ers Squibb says it has Phase III da­ta to back Op­di­vo as an ad­ju­vant treat­ment in pa­tients with mus­cle-in­va­sive urothe­lial car­ci­no­ma.

Bris­tol My­ers Squibb says its PD-1 block­buster came close to dou­bling the av­er­age length of time pa­tients lived with­out dis­ease re­cur­rence, with a me­di­an dis­ease-free sur­vival of 21 months in the treat­ment arm and 10.9 months in the place­bo arm. And for pa­tients whose tu­mors ex­press PD-L1 ≥1%, Op­di­vo re­duced the risk of dis­ease re­cur­rence or death by 47%, ac­cord­ing to BMS.

The phar­ma her­ald­ed the re­sults as a ma­jor step for­ward for im­munother­a­pies in the ad­ju­vant set­ting.

“By mov­ing im­munother­a­py in­to ear­li­er stages of can­cer, we may have the chance to dis­rupt the course of the dis­ease, re­duc­ing re­cur­rence and lead­ing to bet­ter out­comes for pa­tients,” Dana Walk­er, VP and de­vel­op­ment pro­gram lead for gen­i­touri­nary can­cers, said in a state­ment. “Op­di­vo-based ther­a­py has now shown ben­e­fit not on­ly as an ad­ju­vant treat­ment in urothe­lial can­cer, but al­so in ear­li­er-stage melanoma, esophageal and lung can­cer.”

Urothe­lial car­ci­no­ma typ­i­cal­ly be­gins in the cells that line the in­side of the blad­der, but can al­so oc­cur in oth­er parts of the uri­nary tract, in­clud­ing the ureters and re­nal pelvis. More than half of pa­tients who un­der­go rad­i­cal re­sec­tion for in­va­sive urothe­lial car­ci­no­ma ex­pe­ri­ence re­lapse.

In BMS’ Phase III Check­Mate-274 tri­al, 709 mus­cle-in­va­sive urothe­lial car­ci­no­ma pa­tients with a high risk of re­cur­rence af­ter surgery were giv­en ei­ther 240 mg of Op­di­vo or a place­bo bi-week­ly for up to a year.

In ad­di­tion to meet­ing both pri­ma­ry end­points — dis­ease-free sur­vival in all pa­tients and in the sub­set whose tu­mors ex­pressed PD-L1 ≥1% — Op­di­vo met key sec­ondary end­points, in­clud­ing the time pa­tients lived with­out re­cur­rence out­side the blad­der, ureters or re­nal pelvis. This is al­so called non-urothe­lial tract re­cur­rence-free sur­vival, or NU­TRFS. Those giv­en Op­di­vo achieved a me­di­an NU­TRFS of 24.6 months com­pared to 13.7 months for those who got the place­bo.

The safe­ty pro­file was con­sis­tent with pre­vi­ous stud­ies in sol­id tu­mors, ac­cord­ing to BMS. Treat­ment-re­lat­ed ad­verse events oc­curred in 77.5% of pa­tients who re­ceived Op­di­vo, com­pared to 55.5% of pa­tients on the place­bo. Grade 3 or 4 treat­ment-re­lat­ed side ef­fects were seen in 17.9% of pa­tients in the treat­ment arm, ver­sus 7.2% in the con­trol arm.

The pos­i­tive da­ta rep­re­sent a small vic­to­ry in Op­di­vo’s on­go­ing bat­tle with Mer­ck’s su­per­star I-O Keytru­da. Op­di­vo got its first ap­proval in 2014, and has since tacked on a laun­dry list of in­di­ca­tions, in­clud­ing metasta­t­ic non-small cell lung can­cer, metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, and sev­er­al oth­ers in com­bi­na­tion with Yer­voy.

But in the last few years, BMS stum­bled re­peat­ed­ly with an iffy de­vel­op­ment pro­gram and trou­bled com­bo al­liances that left it trail­ing be­hind Mer­ck. Back in De­cem­ber, BMS scut­tled its pro­gram for brain tu­mor pa­tients af­ter Op­di­vo failed to pro­long the lives of pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme.

BMS says it’s bring­ing the full Check­Mate-274 da­ta to the Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy Gen­i­touri­nary Can­cers Sym­po­sium this Fri­day.

A cor­rec­tion has been made to the spelling of Check­Mate-274.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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