Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surg­ing again off da­ta that sug­gest its an­tivi­ral remde­sivir might im­prove sur­vival.

The new da­ta come from an analy­sis Gilead con­duct­ed com­par­ing the death rate and re­cov­ery time of pa­tients in one of its remde­sivir tri­als to a group of 800 pa­tients “with sim­i­lar base­line char­ac­ter­is­tics and dis­ease sever­i­ty” who re­ceived on­ly stan­dard-of-care around the same time. The re­sult, they said, sug­gest­ed that pa­tients who re­ceived remde­sivir had a 62% bet­ter chance at sur­viv­ing than those who did not.

Ret­ro­spec­tive looks are more sus­pect than place­bo-con­trolled tri­als, so the da­ta are far from con­clu­sive. But it does add new ev­i­dence to the ques­tion of whether remde­sivir can im­prove mor­tal­i­ty. The NIH tri­al that led the FDA to au­tho­rize remde­sivir for use in Covid-19 pa­tients on­ly showed that remde­sivir could help pa­tients re­cov­er faster. Few­er pa­tients on remde­sivir died in that tri­al than on stan­dard-of-care — 8% vs 11% — but the re­sults were not sig­nif­i­cant.

For­mer FDA chief sci­en­tist Lu­ciana Bo­rio said that da­ta from ob­ser­va­tion­al stud­ies are dif­fi­cult to in­ter­pret, but that the bulk of ev­i­dence points to remde­sivir help­ing pa­tients sur­vive Covid-19. “It is very like­ly that Remde­sivir does in­deed af­ford pa­tients a mor­tal­i­ty ben­e­fit,” she said in an email. “The gold stan­dard RCT con­duct­ed by the NIH demon­strat­ing the clin­i­cal ben­e­fit of Remde­sivir in im­prov­ing time to re­cov­er wasn’t pow­ered to de­tect a dif­fer­ence in mor­tal­i­ty. It doesn’t mean that there wasn’t one”

In a tweet, for­mer FDA chief Scott Got­tlieb called the re­sults “en­cour­ag­ing” but urged that it need­ed to be con­firmed. The com­pa­ny ac­knowl­edged in their press re­lease that a prospec­tive study was need­ed.

Gilead was up 2% pre-mar­ket on the news, from $74.71 to $76.18.

Oth­er an­a­lysts and ex­perts, though, were more skep­ti­cal and in some cas­es en­tire­ly dis­mis­sive. Pe­ter Bach, the di­rec­tor for the cen­ter for health pol­i­cy and out­comes at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, said on Twit­ter that com­par­ing tri­al par­tic­i­pants to re­al-world pa­tients on­ly works when doc­tors have a good un­der­stand­ing of the dis­ease, some­thing that isn’t the case with Covid-19.

Baird an­a­lyst Bri­an Sko­r­ney com­pared the study to work from Di­di­er Raoult, the French physi­cian who pub­lished in Feb­ru­ary one of the first tri­als on hy­drox­y­chloro­quine in Covid-19. That study, de­spite gin­ning up sig­nif­i­cant in­ter­est in the drug, was seen as rife with is­sues, in­clud­ing in “los­ing” 6 of the tri­al’s 26 pa­tients “in fol­low-up,” 4 of whom died.

In the study, 312 pa­tients from Gilead’s open-la­bel SIM­PLE tri­al were com­pared to 818 re­al-world pa­tients who had sim­i­lar char­ac­ter­is­tics. Pa­tients who re­ceived remde­sivir had a 7.6% chance of dy­ing, com­pared to 12.6% for those who re­ceived stan­dard-of-care. That trans­lates to 62% im­proved odds of sur­vival — or slight­ly more than dou­ble the 30% im­proved odds the NIH tri­al’s raw num­bers sug­gest­ed.

Sun­Trust an­a­lyst Robyn Kar­nauskas said the sur­vival rates in each tri­al were “com­pa­ra­ble,” while ac­knowl­edg­ing the study was “not an ap­ples-to-ap­ples com­par­i­son.”

The remde­sivir pa­tients in the analy­sis al­so had a 74.4% chance of re­cov­er­ing by day 14, ver­sus 59.9% for stan­dard-of-care.

Not every tri­al, though, has found remde­sivir has a ben­e­fit. On the same day as the NIH read­out, The Lancet pub­lished a study from Chi­na that found remde­sivir im­proved nei­ther mor­tal­i­ty nor oth­er pa­tient met­rics. That study, though, was end­ed ear­ly af­ter the first out­break in Chi­na end­ed.

For hos­pi­tals that can get their hands on it, remde­sivir so far has been one of on­ly two proven treat­ments for Covid-19, along with a gener­ic steroid called dex­am­etha­sone. More an­tivi­rals and neu­tral­iz­ing an­ti­bod­ies, though, are now be­ing stud­ied, hav­ing be­come a grow­ing fo­cus of the Trump ad­min­is­tra­tion. If more ther­a­pies prove ef­fec­tive, the new Gilead da­ta could help physi­cians choose the best op­tion.

“While not as vig­or­ous as a ran­dom­ized con­trolled tri­al, this analy­sis im­por­tant­ly draws from a re­al-world set­ting and serves as an im­por­tant ad­junct to clin­i­cal tri­al da­ta, adding to our col­lec­tive un­der­stand­ing of this virus and re­flect­ing the ex­tra­or­di­nary pace of the on­go­ing pan­dem­ic,” in­ves­ti­ga­tor Su­san Olen­der of Co­lum­bia Uni­ver­si­ty Irv­ing Med­ical Cen­ter said in a state­ment.

So­cial: AP Im­ages

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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.”

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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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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Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

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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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