HARMONi-2 Trial

Key Opinion Leader Sentiment Analysis
Ivonescimab (Summit/Akeso) vs. Pembrolizumab (Keytruda)
9.9.2024


Curated by Brian Shields with support from KOL Pulse AI and CHATGPT4.0


Total Impressions 213,024

KOL Sentiment

 -100100Neutral

 

HARMONI-2 Overview

Sentiment Analysis

Based on the content of the conversations and transcripts provided, there is a mix of excitement and cautious optimism regarding the HARMONi-2 trial results featuring ivonescimab versus pembrolizumab for the first-line treatment of PD-L1 positive advanced NSCLC. Here is a sentiment analysis summarizing these mixed perspectives, including the considerations around the rate of male to female patients:

Positive Sentiments:

  1. Excitement Over Results:

    • Statistical Significance: Multiple sources noted the significant improvement in progression-free survival (PFS) for ivonescimab over pembrolizumab, demonstrating a PFS of 11.1 months versus 5.8 months.
    • Impressive Outcomes: The hazard ratio (HR) of 0.51 for PFS was mentioned multiple times, indicating substantial efficacy.
    • Potential Breakthrough: Commentators are enthusiastic about ivonescimab's potential to disrupt the existing standard of care dominated by pembrolizumab.

  2. Broad Effectiveness:

    • Effectiveness Across Subgroups: The drug has shown efficacy across different subgroups, including histology types (squamous and non-squamous) and levels of PD-L1 expression.

  3. General Enthusiasm:

    • Anticipation and Congratulations: Several comments express congratulations and anticipation of further data, emphasizing the promising nature of the results presented.

Negative/Cautious Sentiments:

  1. Concerns Over Control Arm:

    • Inappropriate Comparisons: Multiple tweets mention that the control arm for patients with PD-L1 1-49% did not reflect the standard of care (SOC), which generally includes chemo with pembrolizumab rather than pembrolizumab alone.
    • Bias from Control Arm: This concern raises questions about the meaningfulness and applicability of the trial results.

  2. Limitations and Data Origin:

    • China-Only Data: Several experts highlighted the limitation of the trial data being solely from a Chinese population, raising concerns about its applicability in more diverse populations like those in the US and Europe.
    • Lack of OS Data: There are calls for more complete data, specifically overall survival (OS) data, before making conclusive judgments.

  3. Toxicity and Safety Concerns:

    • Adverse Events: Discussions around the toxicity profile of ivonescimab, specifically higher instances of proteinuria and hypertension, suggest that safety and side effects are non-trivial considerations.

  4. Regulatory Concerns:

    • FDA Approval Skepticism: Despite positive preliminary results, skepticism exists regarding whether the FDA will approve ivonescimab based on the current data, which lacks diversity and SOC controls.

Gender Representation:

  1. Male to Female Ratio:
    • Dominance of Males: One point of emphasis has been the gender representation in the trial population. Approximately 80% of the participants were male, which creates a gender imbalance and raises questions about the generalizability of the results to female patients.

Summarized Insight:

The overall sentiment tilts towards cautious optimism. While there is significant excitement about the positive and striking PFS benefits of ivonescimab, this enthusiasm is tempered by critical concerns about the trial design, control arm validity, the exclusive collection of data from a Chinese cohort, and the gender imbalance in the trial population. The medical community awaits more comprehensive results, particularly concerning overall survival, confirmatory trials in diverse populations, and gender-specific data before fully endorsing ivonescimab as a new standard of care.

  1. Sally Church on x-trial comparisons
  2. Santhosh Ambika on peri-op signal
  3. Kunal Jobanputra MD on PFS and HR
  4. Vinay Prasad MD MPH on single agent pembro
  5. Dr. John Heymach critique
  6. Giannis Mountzios on plenary results
  7. Dr. Deme Karikios on control arm issues
  8. Community Oncology on FDA recommendations
  9. Dr. Antonio Calles on gender representation

This detailed analysis, now incorporating gender representation, provides a more comprehensive understanding of the sentiments in the medical community regarding the HARMONi-2 trial results.

 

 

Top Tweets

Sentiment Analysis

Doctor Name Sentiment Comment
Cancer Data etc
POSITIVE
Congrats @JackWestMD on Harmoni-2 https://t.co/ICArQZER2F
Rajat Thawani
POSITIVE
Harmoni-2 disrupting the harmony in 1L NSCLC. Impressive results from Dr Zhou. And an excellent discussion by Dr Heymach Overall well designed and powered study! One major drawback is use Pembro monotherapy as control in PDL1 1-49% Looking forward to more data on ivonescimab https://t.co/cRb1FDskIz
Stephen V Liu, MD
POSITIVE
Wow. PFS HR 0.54 vs the current standard. This exceeded my expectation by FAR. The mPFS of pembro was 5.8m is basically the same as what we saw in KEYNOTE 042. Ivonescimab gives a PFS of 11.1m with early and consistent separation of the curves. #WCLC24 https://t.co/KNarf3SaN0
Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation
POSITIVE
🔥🚨@OncoAlert HOT OFF THE PRESS. Just presented at the presidential symposium @IASLC #WCLC24 Results of #HARMONi2 trial of #Ivonescimab VS #Pembrolizumab in advanced non-small cell #LungCancer with PD-L1 >1%. ✅ Significant ⬆️mPFS 11.14 vs. 5.82 months (HR 0.51) #Benefit… https://t.co/JCC4A1EzWw https://t.co/ywkhyopGqb
Fawzi Abu Rous, MD
POSITIVE
🔥Impressive results from the HARMONI-2 trial (Ivonescimab vs Pembrolizumab in advanced PD-L1+ NSCLC) #WCLC2024 #IASLC https://t.co/KdO3mYZ73J
Sally Church
NEUTRAL
@onco_park I do not doubt this although squames is a smaller subset than non-sq and they still need to show a sig benefit in OS in US pats. So much hype
Dr Amol Akhade
NEUTRAL
@MaverickNY @JackWestMD Yes. But for PDL1 above 50 % ( where Pembrolizumab monotherapy is approved subset data of ivonescimab vs Pembrolizumab is very impressive. Probably the next trial will have ivonescimab plus chemo vs Pembrolizumab plus chemo . But I aggre that @US_FDA won't give approval… https://t.co/ayTJIUtCpM
Alper Topal, MD
NEUTRAL
💥HARMONI-2 ➡️stage 3b-4, PD-L1 + NSCLC patients ➡️ivonescimab vs pembrolizumab ✅mPFS: 11.1 vs 5.8 months ✅HR: 0.54 ✅ORR: %50 vs %38.5 In all subgroups, including squamous, non-squamous and never smokers, ivonescimab showed superiority to pembro. ⁉️ Is pembrolizumab alone… https://t.co/oslkt3rhTF https://t.co/2EFYt9jo9O
Jarushka Naidoo
NEUTRAL
I think this is a key question @PatrickCMa1, and also if the comparator arm should be chemo-IO rather than IO alone in this subset
Joshua Reuss
NEUTRAL
Impressive data from HARMONi-2 at #WCLC24. While control arm pembro in PD-L1 1-49% is not standard for most, hard to argue against the impressive PFS benefit across PD-L1 strata. https://t.co/SnEXDdaoZk
Devika Das, MD, MSHQS
NEUTRAL
HARMONi2 PFS benefit but Pembro monotherapy might not be the right control arm in 1-49 subgroup Is VEGF inhibitor combo an option for certain subtypes? Toxicity is a concern specially for ECOG 2 Not practice changing for me yet. #wclc24 https://t.co/oOee8gijpA
Dr Riyaz Shah
NEUTRAL
His conclusions https://t.co/4pLWQUkvpA
Sanjay Popat
NEUTRAL
John Heymach’s conclusions on discussing HARMONi-2. V nice overview and balanced discussion #WCLC24 @IASLC https://t.co/LT2frWJlbo
Aakash Desai, MD, MPH
NEUTRAL
@LungCancerRx @lungoncdoc @StephenVLiu @CharuAggarwalMD @DrJNaidoo @AnaVManana @JackWestMD @FawziAbuRous @thenasheffect @LeiDeng3 Discussant Dr. Heymach @MDAndersonNews gives perspective on: ➡️ 1L landscape ➡️ Strengths and Issues (as raised in my last tweet; 1-49% and China only enrollment) Note: KN42- did not show benefit for pembro/chemo ➡️ Consistent Benefit across subgroups, manageable safety… https://t.co/clIvL3tShY https://t.co/Mv1qayqMRF
Sally Church
NEGATIVE
@SuyogCancer @JackWestMD @US_FDA Doing x-trial comparisons in diff pat pop is always tricky. I’ll hold my hat until we see what happens in US pats
Sally Church
NEGATIVE
The sudden early drop-off in the PFS can be explained by the lack of chemo exerting initial disease control giving the IO time to work.
Maria Antonia Vélez
NEGATIVE
@VPrasadMDMPH Completely agree. Control arm doesn’t reflect SOC. Sadly this data doesn’t inform our practice.
Vinay Prasad MD MPH
NEGATIVE
Good oncologists don't give single agent pembro to pdl1 1-49 And really good oncologists don't give single agent pembro to pdl1 <90 Bizarre trial. Maybe this Ab is better but this trial doesn't prove it. https://t.co/YHVFEAkYeL
Dr Deme Karikios
NEGATIVE
HARMONi-2: striking PFS results. Ivonescimab appears efficacious..but... Patients with PD-L1 1-49% were subject to an inferior control arm. SOC is pembro AND chemo. And I know it's hard but wouldn't it be wonderful if OS was the primary endpoint #WCLC24 @csoncol