In the bat­tle against kid­ney can­cer, Mer­ck­'s key­stone im­munother­a­py Keytru­da edges in front

Mer­ck $MRK may not just have a leg up over Bris­tol-My­ers Squibb $BMY in the lu­cra­tive field of lung can­cer. It looks like the com­pa­ny’s block­buster check­point in­hibitor Keytru­da — large­ly con­sid­ered the pre­em­i­nent im­munother­a­py — is on its way to es­tab­lish­ing its edge in re­nal can­cer. Ahead of the Gen­i­touri­nary (GU) Can­cers Sym­po­sium lat­er this week, an ab­stract de­tail­ing the re­sults of a piv­otal study test­ing a Keytru­da com­bi­na­tion in pre­vi­ous­ly un­treat­ed re­nal cell car­ci­no­ma (RCC) pa­tients ce­ment­ed the PD-1 drug’s lead­ing sta­tus.

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 and re­gard­less of PD-L1 sta­tus, com­pared to Pfiz­er’s Su­tent, in first-line RCC pa­tients. Mer­ck of­fered fur­ther de­tail on Mon­day, 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).

An­a­lysts cheered the da­ta. Cowen an­a­lysts 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 Op­di­vo and Ex­elix­is’ $EX­EL TKI Cabome­tyx ver­sus Su­tent in RCC pa­tients.

Keytru­da+In­ly­ta showed im­pres­sive over­all re­sults and will like­ly gain ap­proval in 1L set­ting. While these da­ta may cause some volatil­i­ty in EX­EL stock…the on­go­ing Check­Mate 9ER tri­al should re­port sim­i­lar if not bet­ter re­sults…Cabo re­mains the pre­ferred TKI for RCC based on NC­CN guide­lines. Ad­di­tion­al­ly, we an­tic­i­pate that many physi­cians will view KEYNOTE-426 as a class ef­fect (strong syn­er­gy be­tween TKI and check­point in­hibitor), and this may even re­sult in an in­cre­men­tal in­crease in cabo use in the front­line set­ting with a check­point in­hibitor pri­or to Check­Mate 9ER re­sults and po­ten­tial la­bel ex­pan­sion.

Cred­it Su­isse’s Vi­mal Di­van said the Keytru­da com­bo’s OS haz­ard ra­tio sur­passed ex­pec­ta­tions, con­sid­er­ing in­vestors had an­tic­i­pat­ed a HR around the 0.60 thresh­old.

“Bris­tol-My­ers has been gain­ing share in the 1L RCC mar­ket with their Op­di­vo + Yer­voy com­bo but Mer­ck’s da­ta ap­pears su­pe­ri­or giv­en a low­er OS HR, a pos­i­tive im­pact on PFS and an im­pact be­ing seen across a broad­er pop­u­la­tion. 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,” Di­van said.

In its fourth-quar­ter earn­ings call, Mer­ck said it has al­ready sub­mit­ted an ap­pli­ca­tion to mar­ket Keytru­da to treat first line RCC pa­tients, but Pfiz­er and Mer­ck KGaA on Mon­day said the FDA had agreed to a speedy re­view for their ap­pli­ca­tion to mar­ket a com­bi­na­tion of their check­point in­hibitor Baven­cio and In­ly­ta in RCC pa­tients — the agency is ex­pect­ed to make its de­ci­sion by June.

“(The) Baven­cio com­bi­na­tion with In­ly­ta may get to mar­ket in the US first, hav­ing been grant­ed pri­or­i­ty re­view by the FDA…based on da­ta from JAVELIN Re­nal 101. How­ev­er, we view Keytru­da + In­ly­ta as like­ly to over­take Baven­cio + In­ly­ta as well giv­en greater physi­cian com­fort with Keytru­da over Baven­cio and the pos­i­tive OS da­ta that KEYNOTE-426 de­liv­ered at the first in­ter­im analy­sis (as com­pared to JAVELIN Re­nal 101 where we on­ly saw a PFS ben­e­fit at the in­ter­im analy­sis),” Di­van added.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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Flex­ion se­cures Chi­na deal for os­teo­poro­sis drug; Strug­gling to find a buy­er, Ako­rn throws in the tow­el

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoporosis Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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