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FLAURA2

Lung Cancer

FLAURA2

Manufactured by: AstraZeneca
Product name: Tagrisso® (osimertinib)

 

FLAURA2 Trial KOL Discussion Leaders

Dr Stephen V Liu
Dr. Stephen Liu
Dr. Balasz Halmos
Dr. Balazs Halmos
PatrickForde-1
Dr. Patrick Forde
Dr. Jarushka Naidoo
Dr. Jarushka Naidoo
manochakian
Dr. Rami Manochakian
Dr. Eric Singhi
Dr. Eric Singhi

FLAURA2 Trial Top Tweets

About the FLAURA2 Trial

The FLAURA2 trial is a Phase III, randomized study investigating the efficacy of osimertinib in combination with chemotherapy compared to osimertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations (Ex19del or L858R). Eligible patients had not received prior systemic therapy for advanced disease. The primary endpoint was progression-free survival (PFS) assessed by investigators, with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), and safety. The combination of osimertinib plus chemotherapy resulted in improved PFS over osimertinib alone, with an improved OS. While the combination arm had a higher incidence of adverse events—primarily hematologic toxicities—the safety profile remained manageable. These findings were presented at the European Lung Cancer Congress (ELCC) 2024, with expert commentary provided by Dr. Natalia Valdiviezo and shared by Dr. Stephen V. Liu. Additional insights into the trial’s design, efficacy, and safety outcomes were shared via social media by Dr. Liu and Dr. Martin Dietrich

 

FDA Press Release

Trial Methodology

Study Design: Phase III, randomized, multi-center trial
Population: Patients with EGFR-mutated advanced NSCLC who had not previously been treated
Interventions: Randomization to receive either osimertinib plus chemotherapy or osimertinib alone
Endpoints: Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety assessment.

 

Detailed Results

Progression-Free Survival (PFS)

  • Combination Therapy (Osimertinib + Chemo): Demonstrated an improved median PFS of 25.5 months compared to 16.7 months with osimertinib alone.

    Overall Survival (OS)

  • Following the AstraZeneca announcement the Overall Survival data was presented by Dr. Planchard at the #WCLC25 meeting. The Combination of osimertinib and chemo improved mOS 47.5m v 37.6m with single agent osimertinib (HR 0.77 p=0.02).

Safety and Tolerability

The addition of chemotherapy increased toxicity, including grade 3/4 adverse events, compared to osimertinib monotherapy. 
Flaura2 Safety summary



Clinical Significance

The FLAURA2 trial introduces a potential new standard of care by demonstrating improved efficacy of osimertinib in combination with chemotherapy for EGFR-mutated NSCLC, particularly benefiting patients with high-risk features such as CNS involvement. However, the increased toxicity associated with the combination regimen necessitates careful patient selection and shared decision-making regarding treatment options. 

 

FLAURA2 TRIAL

KOL Sentiment Table

Doctor Name Sentiment Comment
d.planchard POSITIVE Great news !! Another milestone for Tagrisso and our EGFRmut pts... happy to see the completion of the FLAURA2 study @NEJM . Always a step ahead for the US versus Europe !! @EGFRResisters #EGFR @FDAOncology https://t.co/588l4gcMJ6
Martin Dietrich, MD, PhD POSITIVE FLAURA2 Update: OS trend HR=0.75, not final but improved from HR=0.9 at 1st interim analysis. Median OS in osi arm 36 months, similar to FLAURA results . Postprogression tx with old concern of ?combination > sequential tx. SOC for 1st line EGFRmt NSCLC for chemo eligible… https://t.co/SnO20luLow https://t.co/1Yt8D2KIgu
Giannis Mountzios POSITIVE An excellent debate here in #ELCC25 on the optimal choice for 1st Line treatment of EGFR pos #NSCLC : ⭐️. Osimertinib monotherapy VS Combinations (FLAURA2/MARIPOSA) Insightful lectures by @ZPiotrowskaMD and @APassaroMD focusing on efficacy endpoints, biology, toxicity and https://t.co/ugf8xpFS6D
Crispin Hiley POSITIVE The trial that should be done - hopefully coming sometime in the future somewhere. A great discussion on monotherapy vs combo therapy for patients with EGFR mutation positive NSCLC. Patient relevant endpoints so key. #ELCC25 https://t.co/FOtxpOx34j
Santhosh Ambika POSITIVE @JulienMazieres @OncoAlert Rough regimen , but numbers are impressive. Need Flaura2 vs mariposa trial
Yakup Ergün POSITIVE @VPrasadMDMPH @SuyogCancer @myESMO @BalazsHalmosMD @Alfdoc2 @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell I do not accept statements like 'there's no need.' I cannot recommend an inferior treatment in the first-line setting while planning for second-line therapy. It's inappropriate to disregard the number of patients who may move to the second line, as well as the developments that
Yakup Ergün POSITIVE @Alfdoc2 @SuyogCancer @myESMO @BalazsHalmosMD @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell The OS data in FLAURA2 is not yet mature; however, based on the survival curves, the OS benefit seems to become more pronounced over time. It is definitely necessary to discuss with the patient and proceed according to their preference. #elcc24 https://t.co/2Hd59Dps4y
Dr. Estela Rodriguez NEUTRAL Sometimes the FDA approves treatments that I'm not ready to start in all patients. .. @FDAOncology approves #osimertinib for 1st Line metastatic EGFR NSCLC based on #FLAURA2 which compared chemo+ osi vs osi alone w ⬆️ PFS but ⬆️⬆️toxicity This is a great option for selected pts… https://t.co/BFJBcbPtyB https://t.co/p9G3lp2Gg7
Alfredo Addeo MD NEUTRAL @AndresFCardonaZ @StephenVLiu I have had only a few patients treated… and moving from 1 pill a day to this is a big jump that requires a completely different setting and management. I will stick to very selected cases not for everybody hoping to be reassured by better OS at least in specific subgroups
Balazs Halmos NEUTRAL @JackWestMD Certainly CNS disease seems key in decision-making as: ☑️poor progn w osi alone ☑️very large PFS benefit w projected QOL impact ☑️anticipated OS benefit given delta in PFS But even there amount of CNS disease prob relevant as per👇data More complicated choices ahead for sure.. https://t.co/FHt72BI40w
D. Ross Camidge NEUTRAL @DrRiyazShah I favor it as a means to an end. To get to maximal response before consolidation radiation. If viewed this way chemo doesn't have to start day 1. Can be after mex response on tki
Patrick Forde NEUTRAL @DRCamidge @DrRiyazShah Same here, that is how I have used it even before flaura2 ie a pt where goal is to get to definitive therapy to all detectable sites of disease.
Jarushka Naidoo NEUTRAL @DrRiyazShah I think at the end of the day, it is an option. Right now, I'm not sure in which groups (brain Mets/co mutations) I would actually recommend it tho. Fundamentally there are still pts who have a poor trajectory with EGfR-mt dx, & if this helps them- fair enough.
Stephen V Liu, MD NEUTRAL Dr. Natalia Valdiviezo presents post-progression outcomes including OS from FLAURA-2 at #ELCC24. Adding platinum-based chemotherapy to first-line osimertinib for #EGFR NSCLC improved PFS (HR 0.62) but what is the impact on long-term outcomes? https://t.co/gIXQrFOltq
Dr. Estela Rodriguez NEUTRAL Its not everyday that you get to discuss a #lungcancer case with a zoom room of experts. Great conversation with @LeXiuning @MDAndersonNews @LuisRaezMD @mhshospital on 1L EGFR therapy tonight. 👉The standard of care is no longer osimertinib monotherapy- how do you decide https://t.co/HVF5pXDsIt
Bijoy Telivala NEUTRAL @SuyogCancer @myESMO @BalazsHalmosMD @Alfdoc2 @dr_yakupergun @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell Judgement call Older / Frail pt - Osi alone Others can discuss options but if not choosing Osi alone , I would prefer Mariposa rather than Flaura protocol Hoping for the Subq version of Avimantanib
Oncology Brothers NEUTRAL @SuyogCancer @myESMO @BalazsHalmosMD @Alfdoc2 @dr_yakupergun @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell Convenience and good tolerability of oral Osimertinib has been hard to beat. But now with OS data for Chemo + Osi or Ami + Laz, these options should come up more and more. Also we need to get better in addressing toxicities with Ami anyhow (COCOON is similar to what we have done
Balazs Halmos NEUTRAL @SuyogCancer @myESMO @Alfdoc2 @dr_yakupergun @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell It will take a lot of balancing of pros/cons, subset considerations and of course shared decision making to settle on optimal choice Just OS cross-look might end up misleading w good crossover to chemo in FLAURA2 while practically none for ami But a precision onc combo that https://t.co/0EYNmvvdjJ
Bertrand Delsuc NEUTRAL @ArianaPantasy @Banana_Oncology It's my understanding that Astra positions FLAURA2 only for subpopulations like pts with brain mets or other subgroups of interest with a larger clinical benefit than in ITT, given the tox addon of chemo. For the other settings, they're currently relying on osi mono. That's why I… https://t.co/ZIa8sgZnFT
Dr Amol Akhade NEUTRAL Now that latest data for Mariposa is out @myESMO #ELCC2025 , for high risk egfr mutated advanced nsclc , what will u prefer? Osi plus Chemo or Amivantamab plus Lazertinib? @BalazsHalmosMD @Alfdoc2 @dr_yakupergun @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell https://t.co/QFBZPJt3Zr
Stephen V Liu, MD NEUTRAL Dr. @DrRoyHerbstYale at #NYLung24 discusses the relative merits of different 1L #EGFR regimens. Does the PFS improvement with osimertinib plus chemotherapy or amivantamab plus lazertinib over osimertinib alone justify the toxicity and impact on lifestyle? Will vary for patients. https://t.co/vEjYP9Uyet
Stephen V Liu, MD NEUTRAL Dr. @ZPiotrowskaMD at #CFS24 discusses the suddenly complex first line space for #EGFR NSCLC with approvals for osimertinib alone (FLAURA), osimertinib plus chemotherapy (FLAURA2), and amivantamab plus lazertinib (MARIPOSA). Need to learn who benefits most from each approach. https://t.co/jAzZJvzkj2
Santhosh Ambika NEUTRAL @StephenVLiu @DrRoyHerbstYale @gotoPER Probably not worth the toxicity with FLAURA2 data available . Maybe high risk L858R .. we should do Met IHC which may help to stratify. Rx cutaneous a/e prophylactically like Cetuximab protocol , propranolol for scalp lesions . Subq will ameliorate infusion reactions.
Vinay Prasad MD MPH NEGATIVE FDA has no standards Approving chemo + Osi based on FLAURA2 is a terrible decision Osi -> chemo may have similar or better OS with better QoL. FDA has no clue. They are permitting an option that could worsen outcomes for people. Terrible decision, par for course https://t.co/bMgYZk6W9T
Alan Reyes-M.D NEGATIVE Too much toxicity: Chemo/ TKI G3 AE's 53% vs TKI mono G3 AE 11%, with no OS benefit… should we use only in CNS mets patients?? #FLAURA2 #EGFRm #NSCLC https://t.co/C8dX9ijMRb
Antonious Z. Hazim, MD NEGATIVE With increased level of toxicity, is it right to approve a study without showing OS benefit? #FLAURA2 trial #Osimertinib + Chemo vs #Osimertinib alone, in first line Treatment in Patients with #EGFRm Advanced #NSCLC
Alfredo Addeo MD NEGATIVE Dr Piotrowska is delivering an elegant presentation to affirm that Osi could remain SOC for MOST patients: a few reasons (QoL, more options afterwards , yes OS benefit but caveats), ##ELCC25 @myESMO #ESMOambassadors https://t.co/20dx6wzPuy
Vinay Prasad MD MPH NEGATIVE @dr_yakupergun @SuyogCancer @myESMO @BalazsHalmosMD @Alfdoc2 @5_utr @StephenVLiu @ADesaiMD @FordePatrick @n8pennell Osi alone is still fine too Flaura 2 post progression care is not up to the US standard so one doesn't have to add chemo
Dr. Luis E. Raez NEGATIVE usually we change therapy only when we see progression, all of us have a lot of survivors in OSI alone and probably will not change for this or FLAURA2 unless there is PD because these patients are probably selected long term survivors on OSI not the average new EGFR patient that… https://t.co/q7IdMx3AV6 https://t.co/bac0dbrBDh

FLAURA2 Trial Interactive Sentiment Timeline

(click column for tweets)

FLAURA2 KOL PulseRank

Most Active and Engaged US Physicians on X

KOL

Pulse Score
Dr. Stephen Liu
49
ericSinghi-1
Dr. Eric Singhi
40
Dr. Rami Manochakian
29
Dr. Santhosh Ambika
26
Dr. Jarushka Naidoo
23
Oncology Brothers
20
halmos
Dr. Balazs Halmos
19
Dr. Joshua Reuss
18
Dr. Estelamari Rodriguez
18
Dr. Patrick Forde
17
Dr. Charu Aggarwal
14
Dr. Vinayak Prasad
13
Dr. Aakash Desai
12
Dr. Bijoy Telivala
10
Dr. Chandler Park
10
NathanPennel2
Dr. Nathan Pennell
9
Dr. Tejas Patil
9
KelseyPan
Dr. Kelsey Pan
9
Dr. David Camidge
9
Dr. Howard West
8
Dr. Luis Raez
8
Dr. Clay Reed
7
ChristianRolfo
Dr. Christian Rolfo
6
Dr. Sandip Patel
6
Dr. Kyaw Thein
5
Dr. Chul Kim
5
Dr. Thomas Varghese
5
Dr. Gilberto Lopes
5
Dr. Michael Pishvaian
5
Dr. Misty Shields
4
Dr. Julia Rotow
4
Dr. Tisdrey Torres
3
Dr. Narjust Florez
3
Dr. Brendon Stiles
3
Dr. Ana Velazquez Manana
3
Dr. Fawzi Abu Rous
3
Dr. Sewanti Limaye
3
Dr. Isabel Preeshagul
2
Dr. Sarah Waliany
2
Dr. Susan Scott
2
Dr. Suresh Ramalingam
2
Dr. Jeffrey Ryckman
2
dietrich
Dr. Martin Dietrich
2
Dr. Anis Toumeh
2
Dr. Xiuning Le
2
Dr. Sean Mcbride
2
Dr. Dipesh Uprety
2
Dr. Aditya Juloori
2
Dr. Petros Grivas
2
Dr. Marina Garassino
2
Dr. Jonathan Spicer
2
Dr. Patrick Ma
2
Dr. Coral Olazagasti
2