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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Ugur Sahin, BioNTech CEO (AP Images)

Covid-19 roundup: BioN­Tech of­fers da­ta show­ing Pfiz­er-part­nered vac­cine pro­tects against vari­ant; No­vavax at­trib­ut­es re­spon­si­bil­i­ty for PhI­II de­lay to OWS

Ugur Sahin and his team at BioNTech have proffered more evidence that their Pfizer-partnered Covid-19 vaccine can protect people from a much-feared variant of SARS-CoV-2.

Colloquially known as the UK variant, the B.1.1.7 lineage triggered alarms because it appeared more transmissible. Among a series of mutations on its spike protein — the key antigen that all frontrunners in the vaccine race targeted — N501Y was of particular concern because it’s located on the receptor-binding site.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.