Clo­vis soars as its PARP drug ru­ca­parib lines up for FDA re­view with pos­i­tive da­ta

Clo­vis On­col­o­gy stock $CLVS shot up 30% Tues­day af­ter­noon af­ter the biotech laid out com­pet­i­tive piv­otal da­ta for its PARP in­hibitor ru­ca­parib, which has now been ac­cept­ed by the FDA for a pri­or­i­ty re­view. The biotech says it is now start­ing the clock for a re­view that should wrap with a for­mal de­ci­sion by Feb­ru­ary 23 as sev­er­al late-stage ri­vals look to steal its thun­der. The move comes just a day af­ter Pfiz­er com­plet­ed a deal to buy Medi­va­tion and its Phase III PARP in­hibitor ta­la­zoparib for $14 bil­lion.

In­ves­ti­ga­tors for Clo­vis post­ed an over­all ob­jec­tive re­sponse rate of 54% from two small stud­ies with 106 pa­tients suf­fer­ing from ad­vanced ovar­i­an can­cer with BR­CA mu­ta­tions. The me­di­an du­ra­tion of re­sponse was 9.2 months with a 9% com­plete re­sponse rate. Clo­vis added that the “ORR was sim­i­lar for pa­tients with germline BR­CA-mu­tant ovar­i­an can­cer or so­mat­ic BR­CA-mu­tant ovar­i­an can­cer and for pa­tients with a BR­CA1 gene mu­ta­tion or BR­CA2 gene mu­ta­tion.”

That com­pares fa­vor­ably with As­traZeneca’s pi­o­neer­ing PARP Lyn­parza (ola­parib), which was ap­proved with a 34% ORR for an av­er­age of 7.9 months. The FDA over­ruled an FDA pan­el vote against Lyn­parza in 2014, de­spite frets over the drug’s ef­fi­ca­cy.

There’s a long way to go, though, be­fore Clo­vis can lay any claims to hav­ing a best-in-class drug. First, there’s a lot more da­ta to con­sid­er be­fore any fi­nal de­ci­sion ar­rives. Sec­ond, Tesaro $TSRO has al­ready laid out some im­pres­sive pos­i­tive ovar­i­an can­cer da­ta of its own for its PARP ni­ra­parib. Their da­ta high­light­ed a clear im­pact for the tar­get­ed drug in a pop­u­la­tion of germline BR­CA mu­ta­tion car­ri­ers, with a me­di­an PFS of 21 months in the drug group com­pared to 5.5 months in the con­trol arm — a 15.5-month ad­van­tage.

And, third, Pfiz­er has to fol­low up with a much clos­er look at ta­la­zoparib while Ab­b­Vie hus­tles along veli­parib in the clin­ic.

Tesaro shares were down 6% af­ter Clo­vis’s news hit, but the stock had slipped ahead of the news.

Clo­vis al­so has some lin­ger­ing cred­i­bil­i­ty is­sues to deal with. Its oth­er big can­cer drug, rocile­tinib, was scut­tled ear­li­er this year af­ter the FDA forced it to re­cal­cu­late the da­ta used in its sub­mis­sion. Ques­tion­able meth­ods were used to claim an im­pact that the fi­nal da­ta couldn’t sup­port. The ap­proval at­tempt im­plod­ed as an FDA ad­vi­so­ry pan­el turned thumbs down on the trou­bled drug and the biotech was forced to re­struc­ture in the wake of the de­ba­cle. And Clo­vis has re­port­ed in SEC fil­ings that it is un­der in­ves­ti­ga­tion by fed­er­al agen­cies ex­am­in­ing the tim­ing of the biotech’s da­ta sub­mis­sions and cor­rec­tions.

Clo­vis, though, re­tained the com­mer­cial in­fra­struc­ture it had built up, grim­ly de­ter­mined to fol­low through on ru­ca­parib. The biotech has ig­nored re­peat­ed re­quests for in­ter­views in re­cent months.

“Re­cur­rent ovar­i­an can­cer re­mains a very dif­fi­cult dis­ease to treat, even among women who car­ry, or whose tu­mors have a mu­ta­tion in the BR­CA genes. De­spite the avail­able treat­ment op­tions, few ef­fec­tive ther­a­pies are at our dis­pos­al. Thus, the op­por­tu­ni­ty to treat women with germline or so­mat­ic BR­CA mu­ta­tions with ru­ca­parib af­ter two pri­or lines of plat­inum-based ther­a­py, rep­re­sents a mean­ing­ful step for­ward for our pa­tients,” said Robert L. Cole­man, a pro­fes­sor at Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter in Hous­ton and one of the prin­ci­pal in­ves­ti­ga­tors in the ARIEL clin­i­cal tri­al pro­gram.

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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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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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.

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.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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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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