Key Opinion Leaders React to TROPION-Lung01 at #WCLC24
Clinically Significant, Spin, or AI Biomarker Breakthrough???
Curated by Brian Shields with support from KOL Pulse AI and CHATGPT4.0
KOL Sentiment
TROPION-Lung01: Interesting Intersection of Science and PR
The TROPION-Lung01 trial is a phase 3 trial of Datopotamab Deruxtecan (DatoDXD) vs docetaxel in the pretreated setting for the treatment of NSCLC. The clinical trial sponsors AstraZeneca and Daiichi Sankyo chose a fairly aggressive PR strategy as they rolled out their media communications at #ASCO24 , for a data presentation at #WCLC24. The data may potentially lead to an FDA approval in a subset of patients, as the broad population of patients in the trial did not achieve a survival benefit. So what do KOLs think of the data?
The ASCO discusion whihc only included the data from the Press Release was fairly critical of the trial sponsors:
Typical spin with claims of "clinically meaningful but statistically negative results". Further spin with claims of benefit based on subgroup analysis. This could be another example of a potentially billion dollar subgroup analysis in lung cancer- https://t.co/vYxz2s0gmj @JAMAOnc https://t.co/zEiGCB8SAJ
— Bishal Gyawali (@oncology_bg) May 27, 2024
However, there is a great need for treatments in the non-squamous NSCLC population, and Dr. Patrick Forde asked a good questions regarding the potential for an FDA approval from these data (from the ASCO24 discussion).
Dato-did doesn't improve OS in overall study pop vs docetaxel but does in non-sq subgroup. Key decision for @FDAOncology - is a subgroup analysis sufficient to support an approval? My guess is yes but w post marketing requirement for a non-sq trial, #lcsm https://t.co/MoNyS3mWkS
— Patrick Forde (@FordePatrick) May 27, 2024
At #WSCLC24, @ASCO shared a tweet highlighting a quote from presenter Dr. Jacob Sands regarding the potential for DatoDXD in the non-squamous population.
🔬🫁 #WCLC24: New TROPION-Lung01 study data on Dato-DXd for advanced #NSCLC presented today, published in @ASCO_JCO! Learn more about its impact on progression-free survival & safety: https://t.co/QSLyw6Dy18 @sands_jacob @DanaFarber #LungCancer #ClinicalTrials #CancerResearch pic.twitter.com/L5mTJwugGj
— ASCO (@ASCO) September 9, 2024
For more information from Dr. Sands, please see the podcast below:
In this episode, @NarjustFlorezMD & @StephenVLiu recap #WCLC24. @sands_jacob discusses TROPION-Lung01 w/datopotamab deruxtecan & DeLLphi-301 w/tarlatamab. @HHorinouchi reports results from the LUMINOSITY study, & @NReguart gives some perspective on TRUST-II w/talectrectinib.… pic.twitter.com/R7xVaKrpmC
— IASLC (@IASLC) September 11, 2024
However, KOL Dr. Riyaz Shah, an oncologist from the UK was not impressed with the data.
TROPION-Lung01; datoDXd v docetaxel; final OS; higher RR and mPFS (esp in Nsq) already known. Sadly not tantalising #WCLC24 pic.twitter.com/gVI2iBMBmB
— Dr Riyaz Shah (@DrRiyazShah) September 9, 2024
However, there was some excitement from the KOLs regaridng the potential for an AI based biomarker to support the patient selection of DataDXD in this patient population.
Dr. @marinagarassino at #WCLC24 Presidential Plenary presents Normalized Membrane Ratio of TROP2 as a biomarker for datopotamab deruxtecan in TROPION-Lung01 (Dato-DXd vs docetaxel in previously treated NSCLC which previously showed PFS benefit with Dato-DXd. pic.twitter.com/WyjzFXVQAx
— Stephen V Liu, MD (@StephenVLiu) September 8, 2024
Biomarkers critical for optimizing drug delivery and QCS-NMR carries potential (for ADCs that rely on internalization like Dato-DXd) but some practical barriers, particularly digitization of pathology slides on a large scale for this type of analysis. #WCLC24 pic.twitter.com/a1c19fCb3g
— Stephen V Liu, MD (@StephenVLiu) September 8, 2024
Dr Tom John expressed some positivity regarding this new technology for treatment selection of with DATADXD. Could this be a breakthrough?
This actually seems to be a good predictive assay. The question is how deliverable is this assay scoring system?
— A/Prof Tom John (@TommyJohn00) September 8, 2024
Dr. Young Kwon Chae is impressed by the potential for an AI based biomarker.
Impressed by the potential of the AI-based biomarker!
— Young Kwang Chae, MD, MPH, MBA (@youngkwangchae) September 9, 2024
Will the FDA approve DatoDXD in this difficult to treat patient population based on subset data? Will Artificial Intelligence based biomarker save the day? Jacob Plieth asked the question:
So does $DSNKY $AZN dato-dxd get approved on these data in non-squamous 2L NSCLC? Final OS from Tropion-Lung01, via Jacob Sands #WCLC24
— Jacob Plieth (@JacobPlieth) September 9, 2024
HR=0.84 in non-squames (CI upper bound 1.05)
HR=1.32 in squames (we already knew that didn't work)
Q4 2024 Pdufa date pic.twitter.com/xAgj1LI1EM
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