As ri­vals wait in line, Mer­ck­'s Keytru­da scores ear­ly FDA nod for front­line pa­tients with the most com­mon form of kid­ney can­cer

Mer­ck’s key­stone im­munother­a­py Keytru­da is poised to be­come the key front­line ther­a­py for a com­mon form of kid­ney can­cer, ahead of check­point in­hibitor ri­vals who are vy­ing for a piece of the mar­ket for pre­vi­ous­ly un­treat­ed pa­tients with re­nal cell car­ci­no­ma (RCC).

Topline da­ta re­leased last Oc­to­ber showed a com­bi­na­tion of Keytru­da and Pfiz­er’s $PFE ty­ro­sine ki­nase in­hibitor (TKI) In­ly­ta in the KEYNOTE-426 tri­al im­proved over­all sur­vival, pro­gres­sion-free sur­vival and over­all re­sponse rates across risk groups, re­gard­less of PD-L1 sta­tus, com­pared to Pfiz­er’s Su­tent in first-line RCC pa­tients. Mer­ck $MRK of­fered fur­ther de­tail in Feb­ru­ary, in­di­cat­ing the Keytru­da com­bo sig­nif­i­cant­ly im­proved OS [re­duc­ing the risk of death by near­ly half (HR 0.53)] as well as PFS (HR 0.69).

The Keytru­da com­bo had been grant­ed pri­or­i­ty re­view by the US health reg­u­la­tor in Feb­ru­ary, and on Mon­day the drug­mak­er said com­bo had been ap­proved for first­line RCC.

“Bris­tol-My­ers has been gain­ing share in the 1L RCC mar­ket with their Op­di­vo + Yer­voy com­bo but Mer­ck’s da­ta ap­pears su­pe­ri­or giv­en…Op­di­vo + Yer­voy showed an OS ben­e­fit (but not a PFS ben­e­fit) over Su­tent in the Check­Mate-214 tri­al but on­ly in in­ter­me­di­ate and high-risk pa­tients and the ben­e­fit, in our view, be­ing dri­ven by the re­spons­es seen in pa­tients that were PD-L1 pos­i­tive. Over time, the avail­abil­i­ty of a gener­ic ver­sion of In­ly­ta (we as­sume in 2025) could al­so pro­vide a cost ad­van­tage for the Keytru­da + In­ly­ta reg­i­men over Op­di­vo + Yer­voy,” Cred­it Su­isse an­a­lyst Vamil Di­van wrote in a Feb­ru­ary note.

Vamil Di­van

TKI’s such as In­ly­ta and Su­tent block chem­i­cal mes­sen­gers en­zymes called ty­ro­sine ki­nas­es, which help send growth sig­nals in cells. Some an­a­lysts have sug­gest­ed that a TKI/IO com­bo will emerge as the stan­dard of care in first line RCC, and that they an­tic­i­pate sim­i­lar re­sults to emerge from the on­go­ing Check­Mate 9ER tri­al, which is test­ing a com­bi­na­tion of Bris­tol-My­er’s $BMY Op­di­vo and Ex­elix­is’ $EX­EL TKI Cabome­tyx ver­sus Su­tent in RCC pa­tients.

Mean­while, Pfiz­er and Ger­many’s Mer­ck KGaA are not far be­hind. The FDA has agreed to a speedy re­view for their ap­pli­ca­tion to mar­ket a com­bi­na­tion of their check­point in­hibitor Baven­cio and In­ly­ta in RCC pa­tients — and the agency is ex­pect­ed to make its de­ci­sion by June. The com­bo has shown more than 5 months of PFS ben­e­fit (13.8 months vs. 8.4 month with Su­tent; HR = 0.69), but the tri­al has, so far, not demon­strat­ed OS im­prove­ment.

Yaron Wer­ber

In March, Cowen an­a­lysts sur­veyed RCC ex­perts and found that 64% of polled spe­cial­ists ex­pect­ed Keytru­da + In­ly­ta to take the lead­ing po­si­tion in front­line RCC in the next three years. The ex­perts “do not be­lieve that re­sults from Check­Mate-9ER could sal­vage Cabo for a 1L po­si­tion. We be­lieve CaboNi­vo needs to show ben­e­fits in both sur­vival and safe­ty to be com­pet­i­tive. Hence the fu­ture for the drug will be in 2L where Cabo is in­creas­ing­ly ex­pect­ed to be the dom­i­nant drug,” Cowen’s Yaron Wer­ber wrote in a note on Sun­day.

About 73,820 new cas­es of kid­ney can­cer will oc­cur in 2019, and rough­ly 14,770 peo­ple will suc­cumb to the dis­ease this year, the Amer­i­can Can­cer So­ci­ety es­ti­mates.


Im­age: Shut­ter­stock

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.