Actually, Avanzar slip from H1 -> H2 2026 was already disclosed by $DSNKY in Feb. The other two delays are new though $AZN
Looks like $ERAS was taking lessons from $AZN $DSNKY https://t.co/ukxzGGCdas
$DSNKY's first DXd ADC for haematology, DS-3790, enters the clinic. As I reported last November: https://t.co/9CcbISqbqK
@raffcolo Does anyone have any info on how Chia Tai got rights to deuderuxtecan? Does the deuterated form get around $DSNKY patents for DXd? And does DDDXd lie behind all Chia's other ADCs?
Some revelations for ADC nerds: $SNY uses the same MAb in its new CEACAM5 ADC as in the one it discontinued in 2023. Chia Tai claims a deuterated DXd payload (with no link to $DSNKY?). $DSNKY TA-MUC1 ADC uses sacomitatug, not Glycotope's gatipotuzumab.
However, Ideate-Lung02 is still on clinical hold in the EU $MRK $DSNKY
$MRK $DSNKY say FDA has lifted the clinical hold on Ideate-Lung02 after implementation of strategies related to ILD risk: now exclude patients at a high risk of ILD & more frequent review of unblinded efficacy and safety data by IDMC.
CT-gov quietly discloses that $AZN put Datroway into Tropion-Lung17 last Oct. Basically a do-over of Tropion-Lung01, but in non-squam and in TROP2 +ve only (using QCS assay?) https://t.co/cp2di8dcVf $DSNKY $MRK $GILD
...in case you didn't read to the end, $AZN $DSNKY Tropion-Lung15 study of Datroway has also been halted, also because of ILD (though no deaths cited specifically in this case).
Pivotal ifinatamab deruxtecan trial on global clinical halt over ILD deaths. Scoop via @ApexOnco -> https://t.co/XNvk4BD4Sd $MRK $DSNKY $AZN
Newly disclosed targets/modalities from $DSNKY: DS-3790a = anti-CD37 ADC DS9051 = protein degrader for prostate cancer DS5361 = nonsense-mediated mRNA decay inhibitor to increase neoantigen burden https://t.co/dy9R017MvZ
Who won #ESMO25 and who lost? Via @ApexOnco https://t.co/EWzHIIH1Ck $IOBT $CELC $RCUS $CGEM $IDYA $NUVL $AGEN $GILD $DSNKY $INCY $CATX $LPTX $OLMA $SMMT $AVBP $GMAB $EXEL $CGEN $ZLAB $RHHBY
So the ILD grading shenanigans continue. Here's another grade 5 event, adjudicated as grade 3 ILD https://t.co/0IxfsWlY0J $DSNKY $AZN #ESMO25
@raffcolo You saw this detail? Gr5 events include 2 x ILD, 1 x respiratory tract infection, 1 x acute respiratory faillure, 1 x ARDS. Adjuvant setting $DSNKY $AZN #ESMO25 https://t.co/cZYT1ejifZ
#ESMO25 regular abstracts are now live, with first-in-human data being revealed by $LLY $INCY $DSNKY $MRNA $NVS Parabilis & others. Preview via @ApexOnco https://t.co/4oZFL7a5bt
#ESMO25 Sunday late-breakers: LBA20 - $GILD Ascent-03 "One LBA TBC" LBA21 - unassigned https://t.co/hufsi0OmAu $DSNKY $AZN
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
$DSNKY DS3610 starting phase 1 in October. Sting agonist payload ADC (targets still unknown - any ideas?) https://t.co/elQaFNChtq
Herthena-Lung02 data wouldn't have been part of this filing, so *technically* CRL didn't identify issues with data submitted. But $DSNKY (and by implication $MRK) wasn't telling the whole story. Threat of FDA publishing future CRLs might avoid similar obfuscation. Hopefully!
$DSNKY was already told in mid-2024 that Herthena-Lung02 might not work as a confirmatory trial for patritumab-dxd. This wasn't disclosed, and only blew up a year later. Revealed in the latest cache of FDA CRLs, via @ApexOnco -> https://t.co/6pvWiDtUCJ $MRK $AZN
$DSNKY $MRK patritumab deruxtecan CRL as press released (May 2024), and as revealed by the FDA yesterday https://t.co/7jyqA5i3Q3
FDA appears not to have published these recent CRLs (or have I missed them??): Linvoseltamab $REGN Datroway $AZN $DSNKY Talzenna $PFE Columvi $RHHBY
Quite a few (redacted) oncology CRLs released then: $REGN odronextamab x3 SC Rybrevant $JNJ $REPL $ATRA Patri-dxd $MRK $DSNKY Camrelizumab + rivoceranib x2
This is a remarkable amount of disclosure from $DSNKY. Up-fronts & milestones booked under the $AZN & $MRK ADC deals👏👏👏 https://t.co/sdueo35TKs
$DSNKY presenting first clinical data with DS-3939 (anti-TA-Muc1 ADC) at #ESMO25 https://t.co/hWfmymfEXQ
DS3610, new Sting agonist-based ADC (target undisclosed?) from $DSNKY. Starting ph1 shortly. https://t.co/o0klwF2iVJ
Key Datroway trials in NSCLC, via $DSNKY. Note $AZN recently delayed Avanzar readout from H2 2025 to H1 2026. https://t.co/8PqyMBo9hg
OK then, let's try breast cancer! New ph3 for patritumab-dxd $MRK $DSNKY https://t.co/7JEuJUZcBU
$DSNKY $AZN Destiny-Endometrial01 study ("initiaed" today) was first reported on @Apexonco 10 days ago -> https://t.co/iU7lrMMsPL
