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LAURA

Lung Cancer

LAURA

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

About the LAURA Trial

The LAURA trial is a Phase III, double-blind study evaluating the efficacy of osimertinib as consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or L858R mutations who had not progressed during or following definitive chemoradiotherapy. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR), with secondary endpoints including overall survival (OS), CNS-specific PFS, and safety. Osimertinib demonstrated a significant PFS benefit, with a median of 39.1 months compared to 5.6 months in the placebo group. Interim OS analysis showed a positive trend favoring osimertinib. The treatment was well-tolerated, with a manageable safety profile. These landmark results were presented at the 2024 ASCO Annual Meeting by Dr. Suresh S. Ramalingam, with further insights from Dr. Lecia V. Sequist. Additional expert commentary was shared via social media by Drs. Alessandro Russo, Charu Aggarwal, and Sanjay Popat.

LAURA Trial NEJM Publication

FDA Press Release LAURA Trial

LAURA Trial KOL Discussion Leaders
Stephen Liu-1

Dr. Stephen Lui

suresh ramalingam
Dr. Suresh Ramalingam
PatrickForde-1
Dr. Patrick Forde
lecia sequist
Dr. Lecia Sequist
ericSinghi
Dr. Eric Singhi
nathan pennell
Dr. Nathan Pennell

LAURA TRIAL Top Tweets

 

 

 

 

 

 

Trial Methodology

  • Study Design: Phase III randomized clinical trial, focusing on patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC).
  • Randomization: 2:1 allocation of patients to receive osimertinib or placebo after definitive chemoradiotherapy.
  • Endpoints: The primary endpoint was progression-free survival (PFS). Overall survival (OS) and safety/tolerability were secondary endpoints.

• • Crossover: Crossover to osimertinib in the placebo group was permitted upon progression

Detailed Results

  • Progression-Free Survival (PFS): Median PFS was significantly longer in the osimertinib group (39.1 months) compared to the placebo group (5.6 months), with a hazard ratio of 0.16.
  • Improved Trend Toward OS

Safety and Tolerability

  • Adverse Events (AEs):
    • Significant increase in > Grade 3 AEs compared to placebo. 35% osimertinib vs 12% in placebo arm
    • LauraSafety

Clinical Significance

  • Practice-Changing Potential: The significant increase in PFS positions osimertinib as a new potential standard of care for this patient population, enhancing post-chemoradiotherapy management.
  • Implications for Treatment Strategy: The trial highlights the importance of early intervention with osimertinib, compared to traditional approaches or just observation.
  • Unresolved Questions: Full implications for overall survival and long-term QoL outcomes remain to be evaluated as OS data matures.

KOL Sentiments on LAURA Trial

Doctor Name Sentiment Comment
Patrick Forde POSITIVE Impressive increase in PFS with consolidation osimertinib after CRT for pts w unresectable stage III lung cancer. Crossover on progression 82% higher than in most other studies. OS far from mature. Will be adopted as a new standard where it is available I believe. #lcsm #ASCO24 https://t.co/vO4uuOVtAo
Dr. CORAL OLAZAGASTI POSITIVE @RamalingamMD presents the heavily anticipated results of the #LAURA study assessing adjuvant osi vs placebo in EGGR mutated stage III unresecfable NSCLC after CRT 💥 Osi PFS 39.1 vs 5.6M, HR 0.16 👏🏽 👏🏽👏🏽👏🏽 across the room https://t.co/PJU3Ky69Py
Chul Kim POSITIVE Standing ovation after Dr. Ramalingam’s presentation on LAURA! 👏 👏 #ASCO24 https://t.co/skHZZiyTgN
Dr. MARK LEWIS POSITIVE LAURA passes the "truck test" to a rousing ovation at #ASCO24 plenary session, with osimertinib given to patients with locally advanced unresectable stage III EGFRmut NSCLC with no progression following definitive chemoRT #lcsm https://t.co/K8Iwlc9Rbv https://t.co/SXIbtFohJf
Jarushka Naidoo POSITIVE #ASCO24 Plenary🔥 Ph III LAURA trial of consolidation osi v pbo in stage III EGFR+ nsclc: - mPFS 39.1m v 5.6m (HR 0.16; P<0.001) - ⁠ 36m OS 84% v 74% (p NS) Standing ovation for this new SOC, & for the very best of leaders @RamalingamMD @asco @myESMO @IASLC @OncoAlert #LCSM https://t.co/0rFfLNjZxk
Patrick C. Ma, MD POSITIVE LAURA study #ASCO24 Plenary presentation the Applause Ovation Loudness "Inversely Correlating" to its PFS HR 0.16 (p<0.001). 👍🏆👏🎉 Congratulations to Dr. Ramalingham and the LAURA Team! https://t.co/59ExYEiObo
Chul Kim POSITIVE Thoughtful and insightful discussion on practice changing LAURA results by Dr. Sequist @LeciaSequist. 👏 Molecular profiling is critical. Can we identify a small subset of patients who are candidates for de-escalation? #ASCO24 https://t.co/4EIkcybfRc
Charu Aggarwal, MD, MPH, FASCO POSITIVE Beautiful, eloquent and poised discussion of #LAURA by @LeciaSequist emphasizing the importance of PFS benefit in this population, preventing morbidity from CNS Mets while balancing the issue of cost, QoL and biomarkers 👏🏽🫁 @ASCO #ASCO24 @OncoAlert https://t.co/K4tNw5SJCz
Dr. DAVID GANDARA POSITIVE Home run! LAURA: Osimertinib after chemoRT in EGFR-mutated unresectable stage III NSCLC. @ASCO https://t.co/ZeXJESEX33
Dr. THOMAS SEMRAD POSITIVE @drgandara @ASCO Grand Slam
Christine Lovly, MD, PhD POSITIVE LAURA results - immediately practice changing. Trial includes del19 + L858R. Acknowledging benefit of TKI after chemorads but lack of approval for atypical EGFR mut… ➡️ Tomorrow, how would you treat a pt with stage 3 unresectable EGFR G719x? #LCSM #ASCO24 https://t.co/FqhxRrrUhw
Ana I. Velázquez Mañana, MD MSc (she/her/ella) POSITIVE Outstanding discussion by @LeciaSequist of the LAURA study highlighting unanswered questions regarding length of osimertinib use and need for better diagnostics and studies to identify patients who may potentially benefit from de-escalation #LCSM #ASCO24 #ASCOLung https://t.co/8b153KFQMc
Nathan A. Pennell MD, PhD, FASCO NEUTRAL Sobering data from LAURA: the 2 year PFS in the control arm is only 13%, showing how incredibly high risk locally adv EGFRm+ NSCLC can be, 65% with osi. When almost no one is cured with CRT alone, tx with indefinite TKI a'la stage 4 becomes more understandable. #ASCO24 #LCSM https://t.co/DRNUFWUF2O
Timothée Olivier, MD NEUTRAL What to look for in LAURA: 1-proper initial staging? (if not, ⬆️difference btw curves) 2-rate of pts not progressing in the control arm ? looks very low, understaging? 3-crossover, 80%, really ? why not 100%? more details? 4-post-RT tox: looks⬆️with osi https://t.co/Wxu1MPJgf6 https://t.co/jqZYUaiB31 https://t.co/hiNtOkuLAg
Vinay Prasad MD MPH NEGATIVE 80% is false. Crossover to OSI was only given to 50/66 75% of patients I guess the other 25% of patients didn't deserve the best care? Paper also doesn't say if OSI was the next initial therapy or given later @Timothee_MD #asco24 #asco2024. https://t.co/9LKVxtEboh
Steve Lee NEGATIVE @AnaVManana @LeciaSequist @COlazagasti @IvyLorena_Md @MomaVelez11 @NarjustFlorezMD @lungoncdoc @CharuAggarwalMD @ADesaiMD It's pretty pessimistic that the best rationale for forever osimertinib is that stage 3 unresectable EGFR+ NSCLC is actually stage 4 in disguise.

 

 

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