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

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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