Mer­ck KGaA, Pfiz­er's Baven­cio set to seal blad­der can­cer ap­proval af­ter con­fir­ma­to­ry tri­al scores

Baven­cio could use the win.

More than two years af­ter its mak­ers — Ger­many’s Mer­ck KGaA and Pfiz­er — se­cured FDA ap­proval for a form of blad­der can­cer, the com­pa­nies un­veiled that the con­fir­ma­to­ry study test­ing the PD-L1 in­hibitor had per­formed as ex­pect­ed, help­ing pa­tients live longer as a main­te­nance treat­ment ver­sus stan­dard-of-care.

The drug was grant­ed ac­cel­er­at­ed ap­proval on the ba­sis of tu­mor re­sponse and du­ra­tion of re­sponse in May 2017 in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma (UC) whose dis­ease has pro­gressed dur­ing or af­ter plat­inum-con­tain­ing chemother­a­py. On Mon­day, the com­pa­nies said that da­ta from the con­fir­ma­to­ry JAVELIN Blad­der 100 tri­al showed pa­tients treat­ed with Baven­cio lived sig­nif­i­cant­ly longer than those who re­ceived stan­dard care.

A sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival was demon­strat­ed in the Baven­cio arm in each of the co-pri­ma­ry pop­u­la­tions: all ran­dom­ized pa­tients and pa­tients with PD-L1–pos­i­tive tu­mors, the com­pa­ny added, with­out dis­clos­ing the num­bers. The da­ta will be hand­ed over to the FDA.

Baven­cio was late to the check­point in­hibitor game. Mer­ck’s mar­ket-lead­ing Keytru­da and Bris­tol-My­ers’ pi­o­neer­ing Op­di­vo were the first two PD-1/L1 drugs to make the cut, and have since scored var­i­ous ap­provals across im­muno-on­col­o­gy and now reap in bil­lions in sales. Re­gen­eron, Roche and Chi­na-based drug de­vel­op­ers al­so have their own check­points — PARP in­hibitors are al­so the mix.

Last Sep­tem­ber, Cowen an­a­lysts shaved their 2024 pro­jec­tions for Baven­cio by $170 mil­lion to $480 mil­lion, cit­ing flat growth and rel­a­tive­ly few cat­a­lysts ahead. In com­par­i­son, Op­di­vo is ex­pect­ed to gen­er­ate a meaty $12.4 bil­lion that year, and king Keytru­da a hefty $20.6 bil­lion, the an­a­lysts es­ti­mat­ed.

Baven­cio, for which Pfiz­er paid $850 mil­lion up­front in 2014 to part­ner with Mer­ck KGaA on, has had some se­ri­ous set­backs in its quest to make a mark. The part­ners were forced to ad­mit de­feat in ovar­i­an can­cer in March last year af­ter three straight tri­al fail­ures. Months lat­er in No­vem­ber, the drug al­so fiz­zled as a first-line main­te­nance ther­a­py for gas­tric can­cer pa­tients, years af­ter fal­ter­ing in a gas­tric can­cer study to im­prove over­all sur­vival. In 2018, Baven­cio al­so botched a key study in the lu­cra­tive field of lung can­cer.

The com­pa­nies, how­ev­er, did have some luck in kid­ney can­cer. Baven­cio was grant­ed ap­proval in May 2019 in com­bi­na­tion with Pfiz­er’s ty­ro­sine ki­nase in­hibitor In­ly­ta for use as a front­line ther­a­py for re­nal cell car­ci­no­ma, af­ter late-stage da­ta showed the com­bi­na­tion demon­strat­ed a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit. It is al­so ap­proved for use in Merkel cell car­ci­no­ma.

UC ac­counts for about 90% of all blad­der can­cer cas­es. When blad­der can­cer is metasta­t­ic, the five-year sur­vival rate is 5%, ac­cord­ing to Amer­i­can Can­cer So­ci­ety es­ti­mates.

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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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.

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.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

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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Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.

Neil Desai, Aadi Bioscience CEO (Specialised Therapeutics via YouTube)

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

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SPACs have become the preferred fast track for public markets over the past year, but apparently there’s still room for a good, old-fashioned reverse merger.

Cancer-focused Aadi Bioscience announced Monday that they would merge with the struggling public biotech Aerpio Pharmaceuticals. To go along with the merger, Aadi raised $155 million from private investors to commercialize their lead drug, Fyarro, which is now sitting before the FDA. Acuta Capital Partners and KVP Capital led the round.

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