So where does this the #tigit Fc debate? Fc-active: $GSK $ITOS fail, $MRK fail, $RHHBY fail Fc-silent: $RCUS $GILD fail Fc-reduced: $AZN $CGEN ?
Seems my story on $GSK $ANAB falling out was correct in speculating that trials of B7-H3 ADC combos were a problem. Surprisingly, the complaint also cites the I-Spy trial - curious since that's an academic study to which GSK only supplies Jemperli https://t.co/IqBfpezECU
Some background: when researching this story I tried numerous times to call the contact cited at the bottom of $GSK's PR - no reply. I also emailed $ANAB for comment; they replied almost immediately, at what was for them the middle of the night.
Here's why $GSK and $ANAB have fallen out (again), and what's at stake. Via @ApexOnco -> https://t.co/5few1aPJag https://t.co/tbURMQvCOm
@Lord_of_Biotech @Loving_pharma To which $ANAB will claim that the 2020 $GSK settlement related only to combos of Zejula https://t.co/6mJ9GftPYq
@Lord_of_Biotech @Loving_pharma One possibility: $GSK thought that the 2020 settlement allowed it to study Keytruda combos. $ANAB
@Lord_of_Biotech @Loving_pharma Well, that's in the past. For me more relevant is who (knowing $GSK had already had to settle once before) allowed GSK to launch a new study involving Keytruda.
@Loving_pharma @Lord_of_Biotech ...and remember the last time $ANAB alleged this $GSK ended up paying it $60m and >doubling the Jemperli royalty payable!
@Loving_pharma @Lord_of_Biotech So the mere allegation by $ANAB that $GSK studying Keytruda was in breach of the deal put $ANAB itself in material breach? Extraordinary.
@Lord_of_Biotech If the 2020 settlement relating to Zejula combos is anything to go by, then yes. Still unclear what "material breach" $GSK is accusing $ANAB of having committed though.
More detail just out from $ANAB. Seems to be a repeat of the allegations vs $GSK re Zejula, which resulted in Anaptys getting an increased royalty rate in 2020 https://t.co/qExYywgcYB
Reminder of the terms of the $ANAB $GSK deal https://t.co/249IraFiyy
Some possibly relevant detail from $ANAB re the $GSK deal https://t.co/8oDw03ijFt
Spectacular falling out between $GSK & $ANAB. Is this the end of the Jemperli deal? https://t.co/jZV3zDgEW8
$GSK just followed $NVS $LLY $PFE & $SNY into myeloid cell engagers. LTZ tech seems to do this via activity at CLEC5A
Has anyone previously seen the Dreamm-7 data cut for the 3L+ subgroup? Closest I've seen (until yesterday) was a cut for "2 or 3" and "≥4" prior lines, but even here the numbers don't match those cited by the FDA $GSK
@RxRegA Keep checking for whenever $GSK posts the new Blenrep US prescribing info. I can't see it yet, only the old (5th-line +) label.
@RxRegA The thing is this approval seems to be something (a compromise between a CRL based on the adcom vote, and just waving it through 2nd-line?) that the FDA came up with. $GSK basically wanted two 2nd-line approvals.
@RxRegA There was a PR, but that doesn't make this 3rd-line approval any less weird. Was the 3rd-line cohort from Dreamm-7 disclosed before? https://t.co/LO2zuXbar9 $GSK
FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases https://t.co/H92Fm5RbbK via @DrewQJoseph $GSK
Novel synthetic lethality approaches from Synnovation, Artios & $NVS leave much to prove. Via @ApexOnco at #ESMO25 -> https://t.co/B5FWHlomX6 $IDYA $RPTX $GSK
@jeromeleonard5 @NotthatkindofDr GSK4418959 / IDE275? I was kind of hoping to see FIH data on that at #ESMO25 $GSK $IDYA
@kakulukeka @bradloncar To be fair to $GSK Walmsley, however, she was left a terrible legacy by Andrew "we're exiting oncology at the height of the IO revolution" Witty
In a nice bit of timing. $GSK Emma Walmsley will be interviewed on stage at the STAT Summit in Boston on Oct. 15. Agenda details and registration here: https://t.co/Ls3j1cYQ1p
$GSK CEO Walmsley to step down, be succeeded by company’s commercial lead https://t.co/e1uHSdZLYM via @DrewQJoseph
@bradloncar What would you say are Dame Walmsley's three most notable achievements during her 8 years as the head of $GSK?
Kudos to $RHHBY for not trying to bury its Tigit failures. 4 pivotal trials will feature at #ESMO25, incl 2 late-breakers & Imbrave-152. Via @ApexOnco -> https://t.co/8rgBs3O2Wy $RCUS $GILD $AZN $MRK $GSK
FDA brings back $GSK ‘s leucovorin drug that RFK Jr. touted as autism treatment https://t.co/RCMlqXcsf6 via @DrewQJoseph @_daniel_payne
What the FDA is doing with $GSK's Wellcovorin (leucovorin) in autism is f--king insane. Sorry, but I don't have any other words to describe this action.
My earlier take on this and other ADCs that use Sting agonist payloads, from July: https://t.co/B879yVppH0 $DSNKY $ESALY $EXEL $MKGAF $TAK $MRSN $GSK
Surprise! $GSK https://t.co/6PJjOrUnsh
So do you reckon $GSK was interested in buying $VRNA? https://t.co/d82EUvNVnS $MRK https://t.co/IpqBdgO0qb
If I understand correctly LaNova's (Sino's) anti-CDH17 LM-350 just got IND approved to start US trials https://t.co/9IqnIu6PyY $AVBP $GSK
It's... not a CRL! (Yet?) Blenrep Pdufa date extended from 23 July -> 23 Oct $GSK
Nerd alert! What do the latest proposed INNs tell us about $MGNX $AZN $BNTX $GSK $IVBXF and other ADCs? Via @ApexOnco -> https://t.co/vHyv47fFqn H/t @raffcolo
It would be nice if investors, doctors & patients somehow didn't have to wait 7 years for this kind of stuff to be disclosed, but then that would breach confidentiality, and the wheels of capitalism would fall off $GSK https://t.co/WaF6YFVQ8d
Fresh Padzur intervention sees FDA's odac strike down Blenrep. 23 July Pdufa date, tic toc! Via @ApexOnco -> https://t.co/PqbIEAOYQE $GSK
@DrPaulyDeSantis Well... $GSK argument was that you need to start with a high dose for deep responses, then dose-reduce if necessary so ultimately patients get lower dose overall. I guess adcom didn't buy that.
@DrPaulyDeSantis Not only that, but looks like FDA told $GSK to test lower doses, and GSK didn't.
@adamfeuerstein $GSK's mistake: not to have studied Blenrep in smouldering myeloma.
And a final sideswipe from Padzur, who took $GSK to task for enrolling so few US patients into Dreamm-7 & 8: "If the drug is so good patients should be enrolled in the US."
So judging by panellists' comments the key issue was $GSK's refusal to investigate lower Blenrep doses. Pertinent slide from FDA: https://t.co/zCIIyk7lgP
Dreamm-8 vote: 7-1 against $GSK I was wrong!! https://t.co/sdrK1UcH3i
Dreamm-7 vote: 5-3 against! $GSK https://t.co/1KyT8nKamV
...and already my head hurts (slide from $GSK) https://t.co/W5JEfF43d8
Latest OS curves, from IA2 of Dreamm-7 and IA1 of Dreamm-8. Comment from FDA was that Dreamm-8 isn't sufficiently powered for OS, and might never show a benefit $GSK https://t.co/qBzbMbOjX9
Based on the low-key comments from the FDA (nothing like the attacks we've heard at recent adcoms) I see $GSK Blenrep getting positive votes both for Dreamm-7 & 8.
Admirable effort by FDA's Deepti Telajara to present the current treatment paradigm for multiple myeloma $JNJ $BMY $GSK https://t.co/VfdzITcqRY
$GSK Blenrep adcom briefing documents & Youtube link -> https://t.co/7raeXKcV46 Starts 8am ET
It took 3 years for $AZN to report phase 1 data for puxita-S, and now it's gone straight into phase 3. What could possibly go wrong? Via @ApexOnco -> https://t.co/GDdGnBOC1A $GSK
#ESMOGI25 $REGN $GSK $RHHBY $COGT $REPL
@avidresearch At last year's Jefferies London conf $GSK guided to first clinical data in 2025.
$RHHBY dumps Werner helicase. Over to $GSK, $NVS, Nimbus & Moma. Via @ApexOnco -> https://t.co/nrFQP64eMR https://t.co/KiDoTjHV3y
