Roger Dansey, Seagen CEO (via Merck)

As Mer­ck buy­out buzz heats up, Seagen touts a pos­i­tive up­date on their Pad­cev/Keytru­da com­bo

Most of the news at Seagen these days re­volves around hot buzz about a po­ten­tial $40 bil­lion-plus Mer­ck buy­out. But to­day the fo­cus has shift­ed to an ex­per­i­men­tal com­bo that us­es the phar­ma gi­ant’s big PD-1 can­cer drug Keytru­da.

Ex­ecs at Seagen and their part­ner Astel­las post­ed pos­i­tive top-line num­bers for a com­bi­na­tion of Pad­cev and Keytru­da, not­ing a con­firmed over­all re­sponse rate of 64.5% for front­line urothe­lial can­cer pa­tients who are in­el­i­gi­ble for cis­platin.

Me­di­an du­ra­tion of re­sponse had not yet been achieved.

This was the EV-103 Co­hort K ex­pan­sion tri­al, which saw a dip in the ORR rate from the 73% tracked in Co­hort A. But sev­er­al an­a­lysts to­day were quick to of­fer the re­sults at least a ten­ta­tive thumbs-up, while not­ing that a num­ber of ques­tions have to be an­swered be­fore they can ful­ly de­ter­mine the com­bo’s val­ue.

An­drew Berens at SVB Se­cu­ri­ties took a look at the da­ta and not­ed:

We be­lieve the re­sults were gen­er­al­ly ex­pect­ed to come down in larg­er pa­tient num­bers, but still came in above what we viewed as the bar for suc­cess (ORR in the low 60%’s). Me­di­an du­ra­tion of treat­ment was un­reached, and treat­ment ex­po­sure in the tri­al was not dis­closed. More im­por­tant­ly, me­di­an cy­cles of Pad­cev us­age were un­re­port­ed, a key met­ric giv­en that pe­riph­er­al neu­ropa­thy ap­pears to lim­it us­age of Pad­cev in some set­tings, and is like­ly cu­mu­la­tive.

Berens came up with his own set of out­stand­ing ques­tions.

(T)he an­nounce­ment was sparse on key ef­fi­ca­cy de­tails like: 1) du­ra­tion of Pad­cev us­age (num­ber of cy­cles); 2) dura­bil­i­ty met­rics (me­di­an du­ra­tion of re­sponse [DOR] not reached), and 3) the ef­fi­ca­cy of Pad­cev monother­a­py arm. We think that the ab­sence of in­clu­sion of the monother­a­py da­ta in the press re­lease sug­gests the ac­tiv­i­ty/du­ra­tion is like­ly mean­ing­ful­ly less than com­bi­na­tion, im­por­tant to some in­vestors spec­u­lat­ing on the like­li­hood of op­tion­al­i­ty, which would be large­ly dri­ven by syn­er­gies with check­point agents.

Pad­cev is Seagen’s sec­ond best-sell­ing drug, with $340 mil­lion in sales last year. Com­pa­ny ex­ecs have been fo­cused on this new com­bo tri­al as a ma­jor cat­a­lyst for big­ger sales ahead, if they can par­lay the da­ta in­to an ac­cel­er­at­ed ap­proval. But the ju­ry is still out on that score.

Count Boris Peak­er at Cowen, though, as an­oth­er in­ter­est­ed on­look­er. He’s ready to give the com­bo sol­id odds for an ap­proval in the ear­ly part of next year, push­ing fran­chise rev­enue to $665 mil­lion next year.

Ah­san Arozul­lah

“Ap­prox­i­mate­ly half of pa­tients with ad­vanced urothe­lial car­ci­no­ma are in­el­i­gi­ble for cis­platin-based chemother­a­py,” said Ah­san Arozul­lah, SVP and head of de­vel­op­ment ther­a­peu­tic ar­eas at Astel­las, in a press re­lease. Cis­platin-in­el­i­gi­ble pa­tients typ­i­cal­ly have few treat­ment op­tions and a poor prog­no­sis.

Pad­cev is the first an­ti­body-drug con­ju­gate of its kind, the pair says, and works by at­tach­ing it­self to Nectin-4, a cell sur­face pro­tein high­ly ex­pressed in blad­der can­cer. A spe­cif­ic chemother­a­py agent is then re­leased to kill the cells. The com­pa­nies will dis­cuss the re­sults with reg­u­la­to­ry au­thor­i­ties.

Mean­while, Mer­ck is in ad­vanced talks to buy Seagen for about $40 bil­lion or more, or above $200 per share, ac­cord­ing to Wall Street Jour­nal re­ports. The lat­est word from the Jour­nal was that any move would like­ly come af­ter their earn­ings call Ju­ly 28. If the deal goes through, it could be one of the biggest trans­ac­tions in re­cent his­to­ry.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.