Bris­tol My­er­s' Op­di­vo scores pri­or­i­ty re­view in com­mon blad­der can­cer, mark­ing lat­est win in PD-1 bat­tle with Keytru­da

Two months af­ter Bris­tol My­ers Squibb an­nounced Op­di­vo near­ly dou­bled the av­er­age length of time pa­tients with a com­mon blad­der can­cer lived with­out dis­ease re­cur­rence, reg­u­la­tors have said they’ll give the PD-1 block­buster an ex­pe­dit­ed look.

The FDA has grant­ed pri­or­i­ty re­view to Op­di­vo as an ad­ju­vant treat­ment in mus­cle-in­va­sive urothe­lial can­cer, Bris­tol My­ers said on Fri­day, mark­ing the lat­est win in the phar­ma’s bid to out­shine Mer­ck’s su­per­star I/O Keytru­da. The agency tapped Sept. 3 for a PDU­FA date.

Dana Walk­er

Urothe­lial car­ci­no­ma fre­quent­ly be­gins in the cells that line the in­side of the blad­der, but can al­so oc­cur in oth­er parts of the uri­nary tract, in­clud­ing the ureters and re­nal pelvis. While the ma­jor­i­ty of cas­es are di­ag­nosed ear­ly, the chance of re­cur­rence and dis­ease pro­gres­sion is high.

“Af­ter pa­tients un­der­go surgery for mus­cle-in­va­sive urothe­lial car­ci­no­ma, they con­tin­ue to face un­cer­tain­ties giv­en the high rate of dis­ease re­cur­rence and the lack of safe and ef­fec­tive treat­ment op­tions,” Dana Walk­er, Bris­tol My­ers’ VP and de­vel­op­ment lead for gen­i­touri­nary can­cers, said in a state­ment. “We look for­ward to work­ing with the FDA to­wards the goal of bring­ing the first ad­ju­vant im­munother­a­py op­tion to these pa­tients in the U.S.”

The FDA’s de­ci­sion was based on re­sults from the Phase III Check­Mate -274 tri­al, in which Op­di­vo came close to dou­bling dis­ease-free sur­vival, with a me­di­an of 21 months in the treat­ment arm and 10.9 months in the place­bo arm. And for pa­tients whose tu­mors ex­press PD-L1 ≥1%, Op­di­vo re­duced the risk of dis­ease re­cur­rence or death by 47%, ac­cord­ing to BMS.

In ad­di­tion to meet­ing both pri­ma­ry end­points — dis­ease-free sur­vival in all pa­tients and in the sub­set whose tu­mors ex­pressed PD-L1 ≥1% — Op­di­vo met key sec­ondary end­points, in­clud­ing the time pa­tients lived with­out re­cur­rence out­side the blad­der, ureters or re­nal pelvis (al­so called non-urothe­lial tract re­cur­rence-free sur­vival, or NU­TRFS.) Those giv­en Op­di­vo achieved a me­di­an NU­TRFS of 24.6 months com­pared to 13.7 months for those who got the place­bo.

Since snag­ging its first ap­proval in 2014, Op­di­vo has built up a long list of in­di­ca­tions, rang­ing from metasta­t­ic non-small cell lung can­cer to metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, and sev­er­al oth­ers in com­bi­na­tion with Yer­voy. But set­backs over the last few years have left it trail­ing be­hind Mer­ck. While Keytru­da raked in $14.4 bil­lion in sales last year, Op­di­vo took home just un­der $7 bil­lion.

Back in De­cem­ber, BMS agreed to stop mar­ket­ing  Op­di­vo in third-line-or-lat­er small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. And just a week be­fore that, the phar­ma  did the same for its pro­gram for brain tu­mor pa­tients af­ter Op­di­vo failed to pro­long the lives of pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme.

Ear­li­er this year, though, Op­di­vo picked up an­oth­er pri­or­i­ty re­view to treat first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma in com­bi­na­tion with chemother­a­py. The agency set an ac­tion date of May 25 for that ap­pli­ca­tion.

Keytru­da scored an ap­proval in non-mus­cle-in­va­sive blad­der can­cer last Jan­u­ary.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Pascal Soriot, AstraZeneca CEO (AP Images)

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.