Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has ap­proved a new front­line treat­ment for the most com­mon form of liv­er can­cer.

The agency okayed a com­bi­na­tion of Roche’s an­ti-VEGF an­ti­body Avastin and their im­munother­a­py Tecen­triq for pa­tients with un­re­sectable or metasta­t­ic he­pa­to­cel­lu­lar car­ci­no­ma (HCC). The ap­proval comes two weeks af­ter Roche and their big biotech sub Genen­tech pub­lished Phase III re­sults show­ing the com­bo im­proved both pro­gres­sion-free sur­vival and, cru­cial­ly, helped pa­tients live longer than the long-run­ning stan­dard-of-care, Bay­er’s Nex­avar.

In that study, 84% of the 336 pa­tients tak­ing Avastin and Tecen­triq com­bo were alive at 6 months, com­pared to 67.2% of the 165-pa­tient Nex­avar arm. At 12 months, 72.2% of the Roche pa­tients were alive vs 54.6% for Nex­avar.

Richard Finn

“For the first-time we have a reg­i­men that marked­ly im­proves sur­vival over so­rafenib, the stan­dard of care for first-line he­pa­to­cel­lu­lar car­ci­no­ma since 2007, and of­fers pa­tients the op­por­tu­ni­ty for im­proved dis­ease con­trol with a fa­vor­able tol­er­a­bil­i­ty pro­file,” lead in­ves­ti­ga­tor Richard Finn said in a state­ment, us­ing the chem­i­cal name for Nex­avar.

The ap­proval is a ma­jor boon for Roche’s im­munother­a­py pro­gram, which, while pro­duc­ing a block­buster, has nonethe­less long lagged be­hind the mar­ket-lead­ing drugs from Bris­tol My­ers Squibb and Mer­ck. No­tably, Bris­tol My­ers’ Op­di­vo failed last year to give pa­tients sta­tis­ti­cal­ly sig­nif­i­cant im­proved sur­vival over Nex­avar in the same set­ting, al­though that tri­al was as a monother­a­py and the NJ phar­ma in­di­cat­ed they may try to pur­sue oth­er front­line us­es for the drug in HCC.

The new in­di­ca­tion could al­so make a larg­er im­pact, both in rev­enue and for pa­tients, than last week, when Tecen­triq won ap­proval as a monother­a­py in non-small cell lung can­cer by show­ing it could beat chemother­a­py — years af­ter Mer­ck’s keytru­da had done the same. Roche has been oc­cu­py­ing a sim­i­lar po­si­tion in triple-neg­a­tive breast can­cer, af­ter it be­came the first im­munother­a­py ap­proved for that in­di­ca­tion last year.

For Roche, though, the big ques­tions now cen­ter on whether they can show that their an­ti-TIG­IT mol­e­cule tiragolum­ab — the first of the sec­ond-gen­er­a­tion check­point in­hibitor and an area where Roche is ahead of the pack — im­proves on ex­ist­ing ther­a­pies. So far, the da­ta have been mixed.

Pho­to: Richard Finn (Glob­al On­col­o­gy Acad­e­my)

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.

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

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.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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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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