Possible reason, on further thought: $AZN Serena-6 proposed giving treatment sooner than standard; $RHHBY Imvigor-011 proposes to eliminate it in patients who might not need it.
Why no #odac for $RHHBY Imvigor-011? Pdufa date May 2026, uses ctDNA to guide treatment decision in a similar way to $AZN Serena-6 study of camizestrant - which did get an odac.
Just to rub salt into $AZN's wounds then. $ARVN https://t.co/kivCygY5ZL
@ablT315I @AppleHelix Oh, did you notice this gem from Joshua Donaldson (FDA reviewer): "The applicant $AZN cancelled the teleconferences associated with each of these meeting requests." https://t.co/oStDKxXQdV
@AppleHelix Agreed, and I though Capitello-281 was on far shakier ground than Serena-6. FDA basically told $AZN: if you don't show a strong PFS benefit you need OS. Result: weak PSF, no OS benefit. And yet, Truqap gets the thumbs up. What do I know!
OS curves in Truqap Capitello-281 study in PTEN deficient mHSPC $AZN, per adcom https://t.co/nyWpzLQjpJ
Will the FDA approve $AZN camizestrant despite the 6-3 vote adcom against Serena-6?
Yet again I'm wrong on an adcom outcome! So I guess Truqap now sails through unopposed $AZN https://t.co/Ci3f1Qfqk9
$AZN Serena-6 immature OS curves as revealed at the adcom. Not sure we've seen these before. https://t.co/L9oAQxhrh9
@AppleHelix Case against camizetrant seems pretty thin so far $AZN
$AZN refutes FDA's cardiac tox claim https://t.co/bCnd1bRbtL
$AZN camizestrant voting question for the odac: https://t.co/YArq80g3f1
The FDA review team's case against $AZN camizestrant: ESR1 detection isn’t established No info on long-term benefits No OS benefit (might never see one) PFS2 endpoint is BS Calls out cardiac tox https://t.co/RwItZVpGU2
$AZN adcom starting now.
Background on $AZN Serena-6, via @ByMadeleineA -> https://t.co/YNYQ697rlf And on Capitello-281 -> https://t.co/ucskHwSgkC
Reminder that the dual $AZN ODAC takes place tomorrow. Camizestrant Serena-6 trial being debated in the morning, then Truqap Capitello-281 in the afternoon. Youtube link -> https://t.co/RDcvhRqVWR
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
Now Avanzar readout slips from H1 to H2 2026. Plus further delays for Tropion-Lung07 & 08 $AZN https://t.co/iW8zSQw8Uv
FDA launches effort with $AZN $AMGN to speed up clinical trials, using AI https://t.co/k4LjxnDLmq via @LizzyLaw_
...and here comes another $AZN "Titan" project, AZD8359 - Astra's 5th (!) against Steap2 #AACR26 https://t.co/CN4CXTzmr6 https://t.co/u2YfJ9W8xA
Fun to see $LLY snatch $AZN's double-Asco plenary crown at #Asco26
Also... BREAKING.... No #ASCO26 Plenary spots for $AZN. The streak is broken.
Kelonia turns #ASH25 late-breaker into buyout, with $LLY's second move into in vivo Car-T. Via @ApexOnco -> https://t.co/NPhdnuhPu3 $AZN $GILD
$LLY Kelonia tech is based on a modified, inactivated lentivector, so similar to $GILD Interius, $ABBV Umoja & $AZN Esobiotec. $ABBV Capstan uses lipid nanoparticle mRNA. https://t.co/omoGt4MvaM
Just disclosed in #AACR26 abstracts: $AZN AZD4956 = DNA pol theta inhibitor. My story from when it entered phase 1/2 Parthenon study +/-saruparib -> https://t.co/bHoOKqd7da
We know $ARVN is no different, and I doubt $OLMA will be. You can game a trial, but you can't really circumvent basic science $AZN $RHHBY $LLY
$AZN isn't the only company that still believes in PD-(L)1 x TIGIT: SH006 just went into phase 3! https://t.co/AxyTJdFBzF
And here's what $AZN has in store for AZD0120, via @ApexOnco -> https://t.co/xE9uzw5RFp
The enlarged $TPST prioritising a CD19 x BCMA Car-T (TPST-2003), just as $AZN launches its phase 3 study of (ex $GRCL) AZD0120/GC012F: https://t.co/o5QBIUWIS7
So $LLY not interested in oncology applications of Orna's in vivo Car-T? $ABBV $AZN $BMY $GILD https://t.co/wB3rR5LID8
Confirmned discontinuation of $NVS PIT565, which seems to be a specifically targeted T-cell engager (also hit CD2). cf $AZN Titan platform.
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
...while ATR inhibition fails again. No surprise there TBH https://t.co/LNra4muDj0 $AZN $RPTX $MKGAF $RHHBY
$AZN follows $LLY $PFE $AMGN $ONC & $ALPMF into pan-KRAS, but should it be looking more to pan-RAS approaches like $RVMD & $ERAS? Via @ApexOnco -> https://t.co/MioOWziuSt
@NotGenentech @bioinvestor24 Here's a list of just the clinical pan-RAS & pan-KRAS assets from Oncologypipeline $RVMD $LLY $ONC $RHHBY $PFE $ERAS $AZN $AMGN $ALPMF https://t.co/oeb4Yr2nzo
JAB-23425, which appears to have been an earlier molecule in Jacobio's pan-KRAS series, but presumably closely related to $AZN JAB-23E73. Poster from #AACR23 https://t.co/VZytnlTpiV
$AZN just paid Jacobio $100m for ex-China rights to the pan-KRAS inhibitor JAB-23E73 https://t.co/NyCItnvJ0h
...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
@NotGenentech @jq1234t $AZN will 100% succeed with Fc-reduced MAb.
Shock! $LLY reveals Inluriyo + Verzenio combo filing in ESR1m only, despite showing #SABCS25 promise in ESR1w/t. Scoop via @ApexOnco -> https://t.co/gUDeeMpmXb $RHHBY $AZN $ARVN $OLMA
Say hello to $AZN, last man standing in #tigit, and holder of an unconfortable similarity to $RCUS $GILD. Via @ApexOnco -> https://t.co/mqqRC9NaGZ
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 ?
@avidresearch Wait until you see $AZN CD8-based T-cell engagers! (Perhaps.)
$LLY Jaypirca looks best... up to a point. Via @ApexOnco from #ASH25 https://t.co/SgHJrraNrI $ONC $AZN $JNJ $ABBV $NRIX
@herbert_ou Yes, but does this make it an $AZN project? Or does one of the investigators just happen to be affiliated with AZN? I'd never heard of an AZN DLL3 Car-T, and the code is weird.
GC511B appears to be an $AZN Car-T therapy against DLL3. Can anyone corroborate? https://t.co/BsCiZ6UBmI https://t.co/5a6ebgFJXE
Is it a reverse merger? Is it a fund raising? I've tried to decipher the $TPST Factor deal, which is structured to avoid litigation vs $CLLS & $AZN. Via @ApexOnco -> https://t.co/C2XYWk7rtd
Akeso claims cadonilimab is safest in class as well as first in class PD-1 x CTLA-4. So dissing $AZN (notoriously toxic) volrustomig? #Jefferies25
More "first-line" multiple myeloma shenanigans from $AZN (ex $GRCL) AZD0120 / GC012F coming at #ASH25 https://t.co/6uNKnqttQl
@MarkYarchoan I need to doublecheck, but I think $AZN rivegostomig total recruitment target might now be higher than $RHHBY's for tiragolumab. Just amazing.
@gmt9992 Funnily enough, on this morning's media call $AZN specifically called out its significant R&D investment in AZD0120, the CD19 x BCMA Car-T it got from Gracell (FKA GC012F)
Sellside today highlighting $AZN moving puxitatug samrotecan into phase 3 (Bluestar-Endometrial01 study), something @ApexOnco reported four months ago
UK #sadtrombone $AZN https://t.co/pZqQU1E6x4
Quick reminder: I make that 6,536 patients on late-stage rilvegostomig trials $AZN $GILD $RCUS #tigit https://t.co/Qy6CxQTCIc
Also gone is the anti-CD123 ADC AZD9829 (no great surprise there) $AZN https://t.co/tQxWfYjvej
$AZN just discontinued AZD0022
$AZN scrapped a clinical trial collaboration over Asher Bio's CD8-guided IL-2, then started its own study of a near-identical in-house project. Scoop via @ApexOnco -> https://t.co/PPLhL8mKaL
From #ESMO25 yesterday, via @ApexOnco -> how $LLY sprang a surprise for $AZN in FRα. Also key datasets for $GMAB https://t.co/UfWdYMuyKe
Something tells me $GMAB is about to get eclipsed in folate receptor alpha ADC $LLY $AZN #ESMO25 https://t.co/tmaxi9P5bt
@ohadhammer Apparently no PFS data on torvuta-S, which $AZN had promised in the #ESMO25 abstract https://t.co/Z7xkFa5n74
At #ESMO25, AstraZeneca $AZN, Gilead $GILD square off in triple-negative breast cancer https://t.co/X4ZAFATrqi via @DrewQJoseph
So the ILD grading shenanigans continue. Here's another grade 5 event, adjudicated as grade 3 ILD https://t.co/0IxfsWlY0J $DSNKY $AZN #ESMO25
Meanwhile, here's $AZN FRα ADC torvutatug samrotecan in first-in-human Fontana study. No clear cut by FRα expression #ESMO25 via Ana Oaknin https://t.co/dtWYT4VvVO
Pretty decent #ESMO25 data for $LLY Mablink-derived FRα ADC LY4170156, which is about to go into phase 3. 40% ORR in FRα 0-24% expressers! $GILD $ABBV $AZN https://t.co/ArytMgHh2e
Someone at $AZN might be getting fired for failing to organise a standing ovation for Destiny-Breast05 & 11 #ESMO25
How did $AZN Potomac readout match $PFE Crest almost number for number? Plus a #sadtrombone for Tecentriq in $RHHBY Alban, from #ESMO25 yesterday via @ApexOnco -> https://t.co/twVmLvjhMv
Enhertu pushes into early breast cancer, as antibody-drug conjugates move up the line https://t.co/zg7YpsUwB1 via @DrewQJoseph #ESMO25 $AZN $DSKNY
@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
Meanwhile, here's Skyscraper-03, stage III NSCLC. #tigit combo is no better than Imfinzi, but adds tox. No attempt by Rafal Dziaduszko to gloss over how bad these data are #ESMO25 $RHHBY $RCUS $GILD $AZN https://t.co/ACHpJ4614l
V early solid tumour data for Synnovation's Parp1 inhibitor SNV1521 via Pat LoRusso #ESMO25 $AZN $GILD $MKGAF https://t.co/3YOsBFhiqQ
Is this a world record? Seven days from data toplining to appearance in an #ESMO25 late-breaker $AZN https://t.co/NZhQHxF2IT
Now $BMY buys Orbital for... $1.5bn! Focus seems to be autoimmune, but pipeline also includes some oncology work $AZN $ABBV $GILD $SNY $ALPMF https://t.co/rHXCOm2idI
Keep them coming, big pharma! $AZN https://t.co/znDWRNZDhl
#ESMO25 Sunday late-breakers: LBA20 - $GILD Ascent-03 "One LBA TBC" LBA21 - unassigned https://t.co/hufsi0OmAu $DSNKY $AZN
Compare design of Titan projects AZD5492 & AZD9793, versus TED4 molecule AZD6621. All are CD8-guided T-cell engagers $AZN https://t.co/l9OG7LknpE
Especially for the science nerds, I looked at $AZN's latest attempt at CD8-guided T-cell engagement, which seems to be a new take on the Titan planform. Via @ApexOnco -> https://t.co/z49yeGLNnv
$IOBT (-75% this am), $LPTX, $CELC & some other #ESMO25 late breakers, via @ApexOnco https://t.co/FAEqm9otw5 $EXEL $RHHBY $AZN
Two newly disclosed #ESMO25 late-breakers: LBA1 $AZN Destiny-Breast05 (also toplined +ve today) LBA31 ??? https://t.co/QF1kqhZl0J
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
Amazing similarities (& differences?) between Flaura2 vs Mariposa $AZN $JNJ
Indeed. $MRK $AZN $LLY decisions are clearly driven by numerous factors, not solely the incompetence of UK government.
From CHMP documents it seems $AZN has filed Imfinzi + BCG for BCG-naive NMIBC (Potomac indication). Not yet filed in US, as far as I can tell. My earlier take on the limited data topline from this trial https://t.co/anDnaxRmv0
Is $AZN still buying $SMMT?
If you're catching up with #WCLC25 news, @ApexOnco coverage can be found here: https://t.co/Jl2xGAtcZw $SMMY $IDYA $AZN $JNJ $BMY $ZLAB $BNTX
Guess who just went into the clinic with a new menin inhibitor $SNDX $KURA $JNJ $AZN https://t.co/J1NxKIddpD
$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
FDA appears not to have published these recent CRLs (or have I missed them??): Linvoseltamab $REGN Datroway $AZN $DSNKY Talzenna $PFE Columvi $RHHBY
@NotGenentech ...or maybe I should have said the post-covid paths of $AZN vs $PFE
@NotGenentech Also that of $AZN
This is a remarkable amount of disclosure from $DSNKY. Up-fronts & milestones booked under the $AZN & $MRK ADC deals👏👏👏 https://t.co/sdueo35TKs
Key Datroway trials in NSCLC, via $DSNKY. Note $AZN recently delayed Avanzar readout from H2 2025 to H1 2026. https://t.co/8PqyMBo9hg
$AZN filed Imfnizi + chemo for the Matterhorn indication at last, Q4 2025 Pdufa date with priority review. #ASCO25 data -> https://t.co/Hy7o2z7zQk
@avidresearch ...and is still being wasted! $AZN $RCUS $GILD
5,000 patients later $RHHBY finally dumps its #tigit (Sky-14 is quietly said to have failed). Via @ApexOnco -> https://t.co/nAdoMmG6tI $RCUS $GILD $AZN https://t.co/ufrJGMzbh1
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
@AppleHelix Why? $AZN has all the EGFR TKI expertise it needs, and a dominant position. It's made it clear that exon 20ins is irrelevant.
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