Jacob Plieth retweetledi
Jacob Plieth
28.8K posts
Jacob Plieth
@JacobPlieth
Journalist @ApexOnco. The Wolverine Of Biotech / Mr ASH. Never paid for a blue tick. Interested in: oncology. Not interested in: what stock you bought today.
London, UK Katılım Ekim 2012
289 Takip Edilen32.4K Takipçiler
Here's what I make of $CELC overhauled Viktoria-2 gedatolisib study. Comments?
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Design of $AZN Volga is pretty similar to $MRK KN-905, apart from inclusion of an Imjudo cohort. Why does adding Imjudo into the mix make things apparently worse? Tox?
Toni Choueiri, MD@DrChoueiri
JUST IN: VOLGA Phase III is (+)=>Neoadjuvant Durva+EV and adjuvant Durva alone showed EFS & OS benefit. The shorter period of EV is a very attractive option! @DanaFarber_GU @OncoAlert @OncBrothers @AstraZeneca @tompowles1 @AUC3_Official
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$AZN Volga might have matched $MRK $PFE KN-905 in cis-ineligible patients, but here comes chemo-free Padcev + Keytruda in the cis-eligible setting. Via @ApexOnco -> oncologypipeline.com/apexonco/node/…
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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.
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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.
NEJM@NEJM
Original Article: ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer (IMvigor011 phase 3 trial) nej.md/3WIRtEg Editorial: ctDNA-Guided Therapy in Bladder Cancer — Ready? nej.md/4oQSQg5 #Oncology
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Jacob Plieth retweetledi
$VSTM keeps investors waiting in KRAS
oncologypipeline.com/apexonco/node/…
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Catching up with $ZYME pan-RAS inhibitor payload ADCs from #AACR26. Seems the setting for each one is tumours that are RAS-mutated as well as expressing the target antigen (PTK7, Ly6E or Claudin18.2).
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And again, this time with Boehringer! ir.zailaboratory.com/news-releases/… $ZLAB
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Ha ha, great April Fool's joke from $ZLAB $AMGN! ir.zailaboratory.com/news-releases/…
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The $ATRA Ebvallo soap opera - expect more soon. Via @ApexOnco -> oncologypipeline.com/apexonco/node/…
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$DSNKY in a nutshell: expected growth in ADC manufacturing demand didn't materialise, putting CMO minimum-purchase obligations in limbo
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$DSNKY explanation for the curious delay in financials reporting & revision of forecasts: daiichisankyo.com/files/news/pre… Seems unexpected growth in dxd ADC business caused some unwise contracts being signed to secure manufacturing capacity.
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@PDRennert Er... So (not) selling Amtagvi is a front for the real business of selling generic IL-2?!
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@JacobPlieth their BD reached out to sell us proleukin for our CAR-T manufacturing needs ... which seemed odd
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Read $ATRA PR carefully:
FDA agreed that a (not the) single-arm study could (not would) serve.
P Fabre intends to submit updated Allele dataset.
Nowhere does it say the FDA has agreed that Allele will suffice.
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There isn't a cat in hell's chance that $ATRA gets away with just resubmitting the Allele data.
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#JPM26 off to a great start for $ATRA. Looking forward to the FDA publishing the latest CRL.
Madeleine Armstrong@ByMadeleineA
"In a complete reversal of position by the FDA, the CRL claims that the single arm ALLELE trial, which was previously confirmed by the FDA as adequate to support the BLA filing, is no longer considered to be adequate ... for accelerated approval" $ATRA
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