Clinical Trial - Open Access

TROPION-Lung01 Clinical Trial Sentiment

Written by Brian Shields | Sep 13, 2024 2:30:39 PM

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

Total Impressions 110,186

KOL Sentiment

 -100100Negative

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:

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).

At #WSCLC24, @ASCO shared a tweet highlighting a quote from presenter Dr. Jacob Sands regarding the potential for DatoDXD in the non-squamous population.

For more information from Dr. Sands, please see the podcast below:

 

However, KOL Dr. Riyaz Shah, an oncologist from the UK was not impressed with the data.

 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 Tom John expressed some positivity regarding this new technology for treatment selection of with DATADXD. Could this be a breakthrough?

Dr. Young Kwon Chae is impressed by the potential for an AI based biomarker.

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:

 

TopTweets

 

Sentiment Analysis

Doctor Name Sentiment Comment
NEUTRAL
Keeping up with the press-release literature pre-#ASCO24 #TROPION-lung01 #Datopotamab deruxtecan (ADC) showed meaningful (?magnitude) OS advantage vs. chemo in the subgroup of non-squamous NSCLC (but not overall population) #lcsm ⁦👀following…⁩ https://t.co/ia9maehj0c
Dr. Nathan Pennell
NEUTRAL
@FordePatrick @FDAOncology Sounds like how pemetrexed ended up approved only for nonsquamous NSCLC based on planned subgroup.


Dr. Gilberto Lopes

NEUTRAL
Press release just in time to make things more interesting for #ASCO24 - Datopotamab deruxtecan showed "clinically meaningful" overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial.… https://t.co/P64nUM9C79 https://t.co/j2djiOh5nZ
NEUTRAL
Final OS from TROPION-Lung01 #WCLC24 mOS 12.9 vs. 11.8 mo, HR 0.94. By histology NSQ HR 0.84 (w AGAS 15.6 vs 9.8 mo HR 0.65; w/out AGAS 13.6 vs 12.3 HR 0.89) . No benefit in SQ (HR 1.32). Published simultaneously at JCO. https://t.co/pr59OixPRL
Mandy Jackson
NEUTRAL
$AZN AstraZeneca/Daiichi Sankyo TROP2 ADC Dato-DXd overall survival not stat sig in P3 TROPION-Lung01 trial. OS in ITT population 12.9 vs 11.8 months for docetaxel, HR 0.94; but in non-squamous NSCLC where they have sought approval OS is 14.6 vs 12.3 months, HR 0.84. #WCLC24
Timothée Olivier, MD
NEGATIVE
Spin alert with TROPION-Lung01 ! A press release reporting a "clinically meaningful OS improvement" when it "did not reach statistical significance" ⁉️ What is "high level OS" exactly? @IsabelleBoutron et al. ➡️"spin" = "specific reporting strategies, whatever their motive, to… https://t.co/fDexdbWUaI https://t.co/Yk0eUwIOBn
M. Bolton
NEGATIVE
@oncology_bg @JAMAOnc Yep, a good example of spin; can the bar possibly be lower?
Bishal Gyawali
NEGATIVE
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
Dr. Harold Burstein
NEGATIVE
If a drug company feels compelled for SEC or other reasons to issue a press statement, it should report the top-line data. Especially if it claims 'clinically meaningful overall survival improvement' that 'did not reach statistical significance.' https://t.co/lJShSTJ7P6
Dr Amol Akhade
NEGATIVE
So Datopotamab Deruxtecan failed to get statistically significant OS in second line NSCLC. It is numerically better but statistically not significant. Can statistically" not significant " OS benifit be " clinically meaningful " as the Press release heading says ? We will love… https://t.co/brJsrW5pNA https://t.co/jWaZLY83dY https://t.co/gXVJQzIfD9


Dr. Santhosh Ambika

NEGATIVE
@FordePatrick @FDAOncology Agree- FDA WILL approve it in non SqCC. Bar is so low nowadays.
Dr Riyaz Shah
NEGATIVE
TROPION-Lung01; datoDXd v docetaxel; final OS; higher RR and mPFS (esp in Nsq) already known. Sadly not tantalising #WCLC24 https://t.co/gVI2iBMBmB