Timothée Olivier, MD Profile picture
Jun 8, 2023 8 tweets 4 min read Read on X
Hey #ASCO2023, keep following !

Let's have a 👀 at the LUNAR phase 3 trial,
showing an OS benefit with tumor treating fields (TTFs) in addition to SoC in platinum refractory meta NSCLC❗️

3.3 months median OS improvement,
Wow... a new SoC ❓

A few thoughts🧵👇
1/7
First the design :
OPEN LABEL 👇

+again and again, a restricted physician's choice
(see our work here : bit.ly/3DsYqPx)

but let's be fair, it's the same in both arms
2/7 Image
Look at the OS ITT curve... 👇

OS benefit in platinum resistant lung cancer...

HR = 0.74 (0.56 - 0.98), p = 0.035
Ok ok...

BUT now let's talk about the OPEN LABEL design
3/7 Image
I think this is the most important slide 👇

When patients are in the TTF arm, look the level of EXTRA healthcare they get

➡️24/7 support
➡️ arrays changed at home by patient / caregiver every 3⃣ days meaning a special attention at these moments
➡️TTF delivered directly at… twitter.com/i/web/status/1… Image
This is one of the most important slide:

look at the level of "extra" care the patients get in the TTF arm

1⃣ training and 24/7 support
2⃣ arrays changed at home every 3 days with special attention at these moments
3⃣ TTFs delivered directly at patients ' home ❗️
4/7 Image
This is the crux of the issue...
LUNAR = OPEN LABEL
LUNAR is not sham-controlled trial

What would be sham-controlled ?
➡️"false" TTF with all the extra-care around patients

To go deeper @VPrasadMDMPH @adamcifu
bit.ly/3P0HTdq
5/7 Image
Another very compelling argument leading to take the LUNAR results with a BIG grain of salt is...

that we know from a randomized trial led by Jennifer Temel that early palliative care (first line NSCLC) led to better survival ❗

👉2.7 Mo (p= 0.01)
nejm.org/doi/full/10.10…
6/7 Image
That's why we need trials testing therapies like TTFs to be tested within sham-controlled trials ❗️

Thanks for following 🙏
7/7

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More from @Timothee_MD

Jun 4, 2023
Some toughts about the INDIGO phase 3 trial, vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma #ASCO2023

- setting = residual or recurrent disease
- primary EP = PFS = improved from 11.1 to 27.7 Mo (16.6)

Here are some toughts 🧵
1/6 Image
First, we can see that median time from diagnosis ≥ 2.5 years in both groups, so it really looks like mostly recurrent disease.

Now let's make some comparison with another trial, the "PCV trial" -->
This trial was in first-line patients ❗️
2/6 Image
In INDIGO, the primary EP is PFS ...

and OS is a secondary EP which is ... far below in the clinicaltrial.gov list 👇

3/6 Image
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