For the first time in its 100-year-plus his­to­ry, the Amer­i­can As­so­ci­a­tion for Can­cer Re­search is host­ing its an­nu­al meet­ing com­plete­ly on­line. Here’s a glance at some of the ab­stracts — which dropped ear­ly Mon­day — mak­ing the rounds:

Roche con­ced­ed that Tecen­triq failed to help prostate can­cer pa­tients live longer when added to Xtan­di, Pfiz­er and Astel­las’ main­stay an­dro­gen re­cep­tor an­tag­o­nist. The Phase III study dubbed IM­bas­sador en­rolled 759 pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer who had been treat­ed with one pri­or line of chemother­a­py and had pro­gressed af­ter tak­ing an­dro­gen syn­the­sis in­hibitors.

On the pri­ma­ry end­point of over­all sur­vival, no dif­fer­ence was ob­served be­tween the Tecen­triq/Xtan­di and Xtan­di groups. In fact, the me­di­an OS for the com­bo group was slight­ly short­er at 15.2 months com­pared to 16.6 months on the monother­a­py arm.

“Sub­group analy­ses were con­sis­tent with the pri­ma­ry end­point,” the in­ves­ti­ga­tors added in an ab­stract.

Re­searchers had hy­poth­e­sized that Xtan­di may en­hance IFNɣ sig­nalling and sen­si­tive tu­mor cells to an im­mune at­tack. Mid-stage da­ta from Mer­ck have fu­eled that hope, but with the ex­cep­tion of a bio­mark­er-based OK for Keytru­da that po­ten­tial­ly in­clud­ed prostate can­cer, no PD-(L)1 drugs have been ap­proved for the in­di­ca­tion.

Roche is spon­sor­ing a small, open-la­bel study to eval­u­ate us­ing Tecen­triq in the neoad­ju­vant set­ting. Mer­ck, the leader in the check­point field, has a trio of Phase III tri­als un­der­way, pair­ing Keytru­da with Xtan­di, Lyn­parza as well as chemo.

A Chi­nese biotech rais­es ear­ly hope for next-gen CAR-T 

Will the next break­through in CAR-T be made in Chi­na? Gra­cell Bio is build­ing its case for it.

The Shang­hai-based biotech is re­port­ing re­sults from the first five adult pa­tients treat­ed with its al­lo­gene­ic CAR-T for re­lapsed/re­frac­to­ry T-cell acute lym­phoblas­tic leukemia. In a nut­shell:

4 pts achieved MRD neg­a­tive com­plete re­spons­es (MRD- CR) at D28 eval­u­a­tion: 3 of them re­mained MRD- at fol­low-up re-eval­u­a­tions (D118, 61, 161, re­spec­tive­ly, and none was bridged to HSCT); 1 just achieved MRD- CR at D28 and fol­low-up re­sults will be up­dat­ed at the meet­ing. 1 pt achieved MRD+ CR at D14 but had re­lapsed dis­ease at D29.

For the pa­tients with a re­sponse, in­ves­ti­ga­tors doc­u­ment­ed peak ex­pan­sions of the ge­net­i­cal­ly en­gi­neered T cells be­tween the first and sec­ond weeks af­ter in­fu­sion of GC027.

Gra­cell at­tract­ed a well-heeled syn­di­cate — fea­tur­ing 6 Di­men­sions, Temasek and Lil­ly Asia Ven­tures — on the promise to over­come mul­ti­ple con­straints of tra­di­tion­al CAR-T: shrink­ing the man­u­fac­tur­ing process from two weeks to one day, low­er­ing the cost, as well as tweak­ing genes to avoid strong im­mune re­ac­tions.

But they weren’t ex­act­ly able to avoid the safe­ty pit­falls that plagued the ear­li­er prod­ucts. Four pa­tients ex­pe­ri­enced grade 3 cy­tokine re­lease syn­drome and the oth­er one had grade 4 CRS along with el­e­vat­ed lev­els of IL6, IFNγ and TN­Fα — though all were re­solved af­ter treat­ment and sup­port­ive care.

Mer­ck

Af­ter be­ing knocked by a re­jec­tion from the FDA ear­li­er this year, Mer­ck has re­cent­ly re­filed a 6-week dos­ing sched­ule for Keytru­da. At AACR, the phar­ma gi­ant un­veiled the clin­i­cal re­sults be­hind the ap­pli­ca­tion.

The ma­jor take­away from co­hort B of KEYNOTE-555, the com­pa­ny said, is that ad­min­is­ter­ing 400 mg of Keytru­da every six weeks yields com­pa­ra­ble ef­fi­ca­cy and safe­ty as 200 mg every three weeks. At the in­ter­im analy­sis, over­all re­sponse rate was 38.6% — a da­ta point that adds to pre­vi­ous phar­ma­co­ki­net­ic num­bers.

Mer­ck has al­ready se­cured ap­proval in Eu­rope for the less fre­quent reg­i­men, Q6W, which it said would of­fer greater flex­i­bil­i­ty for pa­tients. It didn’t dis­close de­tails from the FDA’s com­plete re­sponse let­ter.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.