#AS­CO21: No­var­tis gears up for CAR-T fight with Gilead in fol­lic­u­lar lym­phoma — and safe­ty could de­fine the bat­tle

Since win­ning the first CAR-T ap­proval in the US back in 2017, No­var­tis has been hard at work ex­pand­ing the reach of its block­buster can­cer drug Kym­ri­ah. Gilead’s Yescar­ta beat it to the punch in fol­lic­u­lar lym­phoma (FL) back in March — but now, No­var­tis says it has new piv­otal da­ta that could give its old ri­val a run for its mon­ey.

Of 94 pa­tients giv­en Kym­ri­ah for re­lapsed or re­frac­to­ry FL, 86% re­spond­ed, ac­cord­ing to pri­ma­ry re­sults re­leased ahead of AS­CO 2021. A to­tal of 66% saw a com­plete re­sponse — which is just a bit high­er than the 65% No­var­tis tout­ed up­on shar­ing in­ter­im re­sults from the Phase II ELARA tri­al back in De­cem­ber.

These new ef­fi­ca­cy re­sults in­clude near­ly twice as many pa­tients as the in­ter­im analy­sis, No­var­tis said. The over­all re­sponse rate al­so saw a small bump, up from the 83% rate record­ed in De­cem­ber. Me­di­an du­ra­tion of re­sponse, pro­gres­sion free sur­vival, and over­all sur­vival were not yet reached, ac­cord­ing to No­var­tis.

De­spite some fa­mil­iar ef­fi­ca­cy fig­ures, Kym­ri­ah could set it­self apart on the safe­ty front. No pa­tients ex­pe­ri­enced Grade 3 or 4 cy­tokine re­lease syn­drome, a well-doc­u­ment­ed side ef­fect of CAR-T ther­a­py. Those re­sults top Yescar­ta’s ZU­MA-5 da­ta, which showed Grade 3 or high­er CRS in 8% of pa­tients.

Grade 1 or 2 CRS oc­curred in 49% of pa­tients in ELARA, with 9% of pa­tients ex­pe­ri­enc­ing Grade 1 or 2 neu­ro­log­i­cal events. One pa­tient ex­pe­ri­enced Grade 4 neu­ro­log­i­cal events, but re­cov­ered. Three par­tic­i­pants died from pro­gres­sive dis­ease, though none of the deaths were treat­ment-re­lat­ed, ac­cord­ing to the Swiss phar­ma.

Ste­fan Hen­driks

No­var­tis plans on run­ning the new da­ta to reg­u­la­tors “as quick­ly as pos­si­ble,” ac­cord­ing to Ste­fan Hen­driks, the glob­al head of No­var­tis On­col­o­gy’s cell and gene di­vi­sion. He con­firmed in an email to End­points News that a sub­mis­sion for the new in­di­ca­tion will come some­time this year.

FL is the sec­ond most com­mon form of non-Hodgkin lym­phoma, with a five-year sur­vival rate of on­ly 20% for pa­tients in the third line and lat­er. Pa­tients with FL have ma­lig­nant tu­mors that grow slow­ly and can be­come more ag­gres­sive over time, and ef­fi­ca­cy of avail­able treat­ments drops off rapid­ly in lat­er lines. Pa­tients in ELARA had a me­di­an of four pri­or treat­ments, though some had tak­en as many as 13.

Yescar­ta won ap­proval as a third-line ther­a­py back in March, be­com­ing the first CAR-T ap­proved for re­lapsed/re­frac­to­ry FL. The OK was based on re­sults from the ZU­MA-5 tri­al, in which 91% of pa­tients saw a re­sponse, 60% of whom achieved a com­plete re­mis­sion, ac­cord­ing to Gilead. Me­di­an du­ra­tion of re­sponse had not been reached.

“As you know, di­rect cross tri­al com­par­isons are me­thod­i­cal­ly and sta­tis­ti­cal­ly not ap­pro­pri­ate due to dif­fer­ences in pa­tient char­ac­ter­is­tics, ef­fi­ca­cy out­come mea­sures (tim­ing) and in-pa­tient vs. out-pa­tient set­ting,” Hen­driks said in an email. “Head-to-head stud­ies have not been per­formed, and no com­par­i­son of safe­ty and ef­fi­ca­cy can be made.”

While Kym­ri­ah beat Yescar­ta out the gate back in 2017, Yescar­ta has the up­per hand in sales, at least in Q1 of this year. The Gilead drug pulled in $160 mil­lion last quar­ter, while Kym­ri­ah made No­var­tis $151 mil­lion.

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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