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ESMO Congress 2026

October 23–27, 2026 · Madrid · 4468 items

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osimertinib

21 people · 22 posts

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Deep dive

Osimertinib's evidence base is anchored by multiple phase III trials: FLAURA showed first-line median PFS of 18.9 vs 10.2 months (HR 0.46) in EGFR-sensitizing-mutation advanced NSCLC [2], with final OS of 38.6 vs 31.8 months [4]; AURA3 established its role in T790M-resistant disease with PFS of 10.1 months vs platinum-pemetrexed [3]; ADAURA extended it to the adjuvant setting [5]. Yet resistance is inevitable and highly heterogeneous, with no clear options beyond chemotherapy after progression [6] — exactly the gap repeatedly discussed at this year's ESMO 2026.

The heavyweight presentation was from Dr. Shun Lu, published simultaneously in NEJM: in EGFR+ NSCLC progressing on osimertinib with MET overexpression and/or amplification, osimertinib + savolitinib was superior to chemotherapy — 1746 screened, 338 randomized, PFS 7.6 vs 5.4 months (HR 0.55), OS HR 0.68, and 12-month OS 70% vs 53%. @dplanchard called it a major new milestone post-osimertinib and a new therapeutic standard, urging MET testing for all EGFRm patients at progression, while admitting that access to osimertinib + savolitinib is the hardest step for patients upon return.

ctDNA was the other main thread. The exploratory FLAURA2 analysis [1] showed Week 6 plasma EGFRm clearance of 88% with osimertinib + chemotherapy vs 89% with osimertinib alone — nearly identical; among cleared patients, combination therapy still improved PFS (HR 0.52; another post cited HR 0.51), meaning early clearance is prognostic, not predictive, and cannot justify omitting chemotherapy; for the ~20% of patients with undetectable baseline ctDNA, osimertinib alone achieved mPFS of 30 months. The phase II PACE-LUNG took another approach: patients ctDNA-positive at Week 3 (72/255) added 4 cycles of chemotherapy, with mPFS 17.8 months and OS 31.5 months from start of osimertinib — no comparator, but encouraging.

On the news side, NEJM's Ahead of Print confirmed the savolitinib combination publication without disclosing additional details; separate coverage added Baili Tianheng's iza-bren (EGFR×HER3 bispecific ADC) plus osimertinib first-line China phase II update: ORR 100%, 18-month PFS rate 92.2%, median follow-up 22.8 months; a phase II trial of osimertinib ± cyclosporine A (NCT07874490, planned 60 patients) also opened recruitment. In terms of advancing knowledge, the savolitinib combination moves the post-progression landscape of limited options described in [6] into a stage with both PFS and OS benefit, hailed by experts as a new standard, while FLAURA2 clarifies the interpretive boundary of ctDNA clearance. The limitations are equally clear: PACE-LUNG has no comparator, the FLAURA2 analysis is exploratory, and access was flagged on-site as the biggest practical barrier.

References
  1. 1.2719RO FLAURA2: Analysis of on-treatment plasma EGFRm dynamics and associated clinical outcomes in patients (pts) with EGFRm advanced NSCLC treated with first-line (1L) osimertinib (osi) ± platinum–pemetrexed (plat–pem) · ESMO 2026 2026
  2. 2.Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer · N Engl J Med 2018
  3. 3.Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer · N Engl J Med 2017
  4. 4.Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC · N Engl J Med 2020
  5. 5.Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer · N Engl J Med 2020
  6. 6.Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer · Br J Cancer 2019
  7. 7.Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology · J Natl Compr Canc Netw 2017
Floor
  6. Dra. María Natalia Gandur Quiroga

    🧬 Early ctDNA clearance tells us a lot about prognosis — but not necessarily which treatment to choose.

    引用@

    OncoAlert 4Sight Abstracts to be Presented at #ESMO26 FLAURA2: Analysis of On-Treatment Plasma EGFRm Dynamics and Associated Clinical Outcomes in Patients With EGFRm Advanced NSCLC Treated With First-Line Osimertinib ± Platinum–Pemetrexed @dplanchard 🫁 Exploratory ctDNA analysis of phase III FLAURA2: plasma EGFRm clearance (ddPCR) at Weeks 1, 2, 3 and 6 with first-line osimertinib ± platinum–pemetrexed in EGFRm advanced NSCLC. ➡️ Week 6 clearance: 88% vs 89% ➡️ Week 6 cleared: PFS HR 0.52 (0.36–0.76); not cleared: PFS HR 0.40 (0.16–0.97) ➡️ Week 6 OS HR 0.73 (cleared) and 0.50 (not cleared) ✅ Clearance was prognostic but not predictive; osimertinib + platinum–pemetrexed was superior to osimertinib regardless of clearance status. #NSCLC 🎙️ David Planchard 👥 Pasi Jänne · Ying Cheng · James Yang · Noriko Yanagitani · Sang-We Kim · Shunichi Sugawara · Yan Yu · Yun Fan · Sarayut Geater · Konstantin Laktionov · Chee Lee · Natalia Valdiviezo · Samreen Ahmed · Jean-Marc Maurel · Igor Andrasina · Jonathan Goldman · Dana Ghiorghiu · Yuri Rukazenkov · Alex Todd · Kunihiko Kobayashi (4Sight Made from Abstracts publicly available at the ESMO website) Pinging our faculty @christine_lovly, @GlopesMd, @DrSanjayPopat, @StephenVLiu, @jillfeldman4, @UOzkerim, @DrMirallas, @MartinReck2 , @bmassutis @UmbertoMalapel1 , @CharuAggarwalMD @peters_solange, @HenningWillers, @HHorinouchi, @BRicciutiMD, @PercyLeeMD, @bensolomon1, @Latinamd, @DrJNaidoo, @barlesi, @VanitaNoronha, @ChristianRolfo @Tony_Calles @s_couraud @marinagarassino @g_mountzios @BairdAM @barlesi @JFreemanDaily @Piuchagarrido @PercyLeeMD @bensolomon1 @VanitaNoronha @alexdrilon @JordiRemon @JulienMazieres @TerriConneran @HenningWillers

    Same topic osimertinib · 21 peopleEGFR#NSCLC#LUNGCANCER#EGFR#CTDNA#PRECISIONONCOLOGY108 views3 likes1 repost0 replies
  10. MeDucation

    @HHorinouchi's FLAURA2 summary carries the teaching point of the day: early plasma EGFRm clearance was prognostic but not predictive, so it shouldn't be the reason to add or skip c

    引用@

    🆙#ESMO26 Rapid Oral I: #LCSM Mets 🔥FLAURA2: Analysis of On-Treatment Plasma EGFRm Dynamics and Associated Clinical Outcomes in Patients (Pts) With EGFRm Advanced NSCLC Treated With First-Line (1L) Osimertinib (Osi) ± Platinum–Pemetrexed (Plat–Pem) 🎙️ @dplanchard 🔢2719RO 🎯EGFRm Clearance Prognostic but Not Predictive 🎯Osi+Plat–Pem Benefit Over Osi Alone Consistent Regardless of Clearance Status at Wk 1, 2, 3, 6; Clearance Rates Comparable Between Arms ☑️NCT04035486 🔗 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/255 @OncoAlert @Larvol @myESMO @IASLC @EGFRResisters

    Same topic osimertinib · 21 people#LCSM42 views1 like0 reposts0 replies
  18. METCrusaders

    Promising news about osimertinib + savolitinib for EGFR-mutated NSCLC with MET overexpression or MET amplification #lscm #ESMO26

    引用@

    Simultaneous publication @NEJM of #ESMO26 presentation from Dr. Shun Lu. Osimertinib + savolitinib superior to chemo in EGFR+ NSCLC post osimertinib with MET overexpression and/or amp: 338 randomized / 1746 screened: PFS 7.6 vs 5.4m, HR 0.55, OS HR 0.68 https://www.nejm.org/doi/full/10.1056/NEJMoa2611335

    Same topic osimertinib · 21 peoplesavolitinibEGFRMET#LSCM5 views0 likes0 reposts0 replies
  21. mp.weixin.qq.com

    SystImmune Presents iza-bren Plus Osimertinib Update in First-Line EGFRm NSCLC: ORR 100%, 18-Month PFS Rate 92.2%

    At ESMO 2026, SystImmune presented a China phase II follow-up update of iza-bren plus osimertinib in first-line EGFRm NSCLC, showing an ORR of 100% and an 18-month PFS rate of 92.2%. iza-bren is a bispecific EGFR×HER3 ADC. Median follow-up was 22.8 months, about 10 months longer than at WCLC 2025. The original article says such a PFS curve has never been seen in first-line EGFR lung cancer and sums it up as zero patients with progression.

    Same topic osimertinib · 21 peopleEGFRNo engagement yet
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