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.

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’ 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.

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.

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.