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ESMO Congress 2026

October 23–27, 2026 · Madrid · 5037 items

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pembrolizumab

★★★

56 people · 81 posts

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Deep dive

Pembrolizumab's evidence base was built on published phase 3 trials: KEYNOTE-024 showed that in previously untreated advanced NSCLC with PD-L1 ≥50% and no sensitizing EGFR mutation or ALK translocation, monotherapy extended median PFS over platinum-based chemotherapy (10.3 vs 6.0 months), establishing single-agent first-line standard of care for this high-expression population [7]; KEYNOTE-189 established the value of adding chemotherapy in metastatic nonsquamous NSCLC without sensitizing mutations [11]; mechanistic studies linked tumor mutation burden and pre-existing intratumoral CD8+ T cells to efficacy [9][10].

The headline pembrolizumab story at this ESMO is PERSEE (GFPC 01-2020), a phase 3 open-label trial: 321 patients with PD-L1 ≥50% advanced NSCLC were randomized first-line to pembrolizumab plus platinum-based chemotherapy or pembrolizumab alone, with PFS by blinded central review as the primary endpoint. Median PFS was 16.1 vs 6.9 months, HR 0.56 (0.43–0.74), p<0.001; ORR 77.5% vs 50.3%; median OS 50.2 vs 29.9 months, HR 0.77 (0.57–1.05), a notable numerical difference that missed statistical significance, and OS was not the primary endpoint; grade ≥3 toxicity was 53.8% vs 19.3%. The trial was published simultaneously in Annals of Oncology.

The main-site news did not independently cover PERSEE; it instead covered two other pembrolizumab combination threads: in the phase 3 INTerpath-001, the mRNA-based individualized neoantigen therapy intismeran autogene plus pembrolizumab as adjuvant treatment of resected melanoma reduced the risk of recurrence or death by 42% versus pembrolizumab alone, corresponding to abstract LBA1 [6]; and Kelun-Biotech reported phase 2 results of sac-TMT plus pembrolizumab in advanced pMMR endometrial cancer with a confirmed ORR of 40%. Field posts also flagged final phase 2 IOV-COM-202 data — lifileucel plus pembrolizumab in checkpoint inhibitor-naïve advanced melanoma, with ORR 62.5%, CR 29.2% and mPFS 19.8 months — as well as the negative KEYNOTE-975, in which pembrolizumab plus dCRT did not improve EFS or OS in esophageal/GEJ cancer [3].

PERSEE's advance is that it directly tests the question left open by [7]: whether single-agent therapy is enough for everyone with PD-L1 ≥50%. The answer leans toward the combination substantially extending PFS and raising response rates, but grade ≥3 toxicity rose nearly threefold, and identifying which patients truly need the combination remains unresolved; the open-label design and OS not being the primary endpoint and missing significance also counsel restraint. The lifileucel combination remains a phase 2 signal, awaiting confirmation in the phase 3 TILVANCE-301.

References
  1. 1.2551TIP Krascendo 3: A randomised, phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer · ESMO 2026 2026
  2. 2.2614O 2614O · ESMO 2026 2026
  3. 3.2875O Pembrolizumab or placebo plus concurrent definitive chemoradiotherapy in esophageal and gastroesophageal junction (GEJ) cancer: The phase 3 randomized KEYNOTE-975 study · ESMO 2026 2026
  4. 4.3821P Sustained survival with extended follow-up of tarlatamab plus anti-PD-L1 as first-line maintenance (1LM) after chemoimmunotherapy for extensive-stage small cell lung cancer (ES-SCLC): DeLLphi-303 phase 1b study · ESMO 2026 2026
  5. 5.7P Proffered paper 1: Gastrointestinal tumour, upper digestive · ESMO 2026 2026
  6. 6.LBA1 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma… · ESMO 2026 2026
  7. 7.Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer · N Engl J Med 2016
  8. 8.PD-1 Blockade in Tumors with Mismatch-Repair Deficiency · N Engl J Med 2015
  9. 9.Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer · Science 2015
  10. 10.PD-1 blockade induces responses by inhibiting adaptive immune resistance · Nature 2014
  11. 11.Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer · N Engl J Med 2018
  12. 12.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial · Lancet 2016
Floor
  5. Gil Morgan, MD

    An important negative trial to be presented at #ESMO26

    引用@

    OncoAlert 4Sight Abstracts to be Presented at #ESMO26 2875O: Pembrolizumab or Placebo Plus Concurrent Definitive Chemoradiotherapy in Esophageal and Gastroesophageal Junction (GEJ) Cancer: The Phase 3 Randomized KEYNOTE-975 Study @MDmanishshah @BennounaJaafar @cbcbc1971 🔬 Phase 3, double-blind trial (n=703): pembrolizumab or placebo plus definitive chemoradiotherapy in untreated, unresectable esophageal/GEJ cancer. Dual primary endpoints: EFS and OS. ➡️ CPS ≥10 EFS: median 15.2 vs 14.7 mo; HR 0.97 (0.77–1.23); P=0.3994 ➡️ CPS ≥10 OS: median 32.2 vs 35.0 mo; HR 1.00 (0.77–1.30); nominal P=0.5003 ➡️ Grade 5 AEs 13% vs 10%; discontinuation due to AEs 34% vs 27% ✅ Pembrolizumab + dCRT did not significantly improve EFS in PD-L1 CPS ≥10; no new safety signals observed. 🎙️ Manish Shah 👥 Jaafar Bennouna · Toshihiko Doi · Lin Shen · Ken Kato · Antoine Adenis · Harvey Mamon · Markus Moehler · Xiaolong Fu · Byoung Chul Cho · Sonal Bordia · Pooja Bhagia · Chie-Schin Shih · Anjali Desai · Peter Enzinger (4Sight Made from Abstracts publicly available at the ESMO website) Pinging OncoAlert Faculty @CathyEngMD, @BenWestphalen, @graokane, @NiuSanford, , @GillSharlene, @pashtoonkasi, @DrVilmaPBarcia, @Erman_Akkus, @GIMedOnc, @UOzkerim, @MarioBalsaMD, @p_ciracimd, @DraMartinezLago, @DaisukeKotani, @Aiims1742, @ARosen380, @realbowtiedoc, @KoheiShitara,

    ★★★Same topic pembrolizumab · 56 people1072 views13 likes8 reposts0 replies
  12. Dra. María Natalia Gandur Quiroga

    🫁 PD-L1 ≥50% has long supported pembrolizumab monotherapy — but PERSEE asks whether some of these patients should receive more upfront.

    引用@

    OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Pembrolizumab With or Without Platinum-Based Chemotherapy as First-Line Treatment in Advanced NSCLC With PD-L1 ≥50%: PERSEE Phase 3 Trial (GFPC 01-2020) @decroisette @BenjaminBesseMD @LGreillier @C_Ricordel @FGuisier 🫁 Phase 3, open-label (n=321): pembrolizumab + platinum-based chemotherapy vs pembrolizumab alone, first-line advanced NSCLC with PD-L1 ≥50%. Primary endpoint: PFS by blinded central review. ➡️ Median PFS 16.1 vs 6.9 mo; HR 0.56 (0.43–0.74); p<0.001 ➡️ Median OS 50.2 vs 29.9 mo; HR 0.77 (0.57–1.05); ORR 77.5% vs 50.3% ➡️ Grade ≥3 TRAEs 53.8% vs 19.3% ✅ Pembrolizumab-chemotherapy significantly improved PFS vs pembrolizumab monotherapy and may help refine treatment selection. #NSCLC #LungCancer 🎙️ Chantal Decroisette 👥 Renaud Descourt · Christos Chouaid · Maurice Pérol · Benjamin Besse · Laurent Greillier · Olivier Bylicki · Charles Ricordel · Florian Guisier · Radj Gervais · Roland Schott · Jean-Bernard Auliac · Gilles Robinet (4Sight Made from Abstracts publicly available at the ESMO website) Pinging our OncoAlert Lung Cancer 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 @LeciaSequist @bensolomon1 @VanitaNoronha +@alexdrilon @JordiRemon @caliraf @JulienMazieres @TerriConneran

    Same topic pembrolizumab · 56 people#NSCLC#LUNGCANCER#PDL1#PRECISIONONCOLOGY192 views6 likes4 reposts0 replies
  15. Gil Morgan, MD

    🔁 Important findings from the PERSEE Phase 3 trial to watch at #ESMO26!

    引用@

    OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Pembrolizumab With or Without Platinum-Based Chemotherapy as First-Line Treatment in Advanced NSCLC With PD-L1 ≥50%: PERSEE Phase 3 Trial (GFPC 01-2020) @decroisette @BenjaminBesseMD @LGreillier @C_Ricordel @FGuisier 🫁 Phase 3, open-label (n=321): pembrolizumab + platinum-based chemotherapy vs pembrolizumab alone, first-line advanced NSCLC with PD-L1 ≥50%. Primary endpoint: PFS by blinded central review. ➡️ Median PFS 16.1 vs 6.9 mo; HR 0.56 (0.43–0.74); p<0.001 ➡️ Median OS 50.2 vs 29.9 mo; HR 0.77 (0.57–1.05); ORR 77.5% vs 50.3% ➡️ Grade ≥3 TRAEs 53.8% vs 19.3% ✅ Pembrolizumab-chemotherapy significantly improved PFS vs pembrolizumab monotherapy and may help refine treatment selection. #NSCLC #LungCancer 🎙️ Chantal Decroisette 👥 Renaud Descourt · Christos Chouaid · Maurice Pérol · Benjamin Besse · Laurent Greillier · Olivier Bylicki · Charles Ricordel · Florian Guisier · Radj Gervais · Roland Schott · Jean-Bernard Auliac · Gilles Robinet (4Sight Made from Abstracts publicly available at the ESMO website) Pinging our OncoAlert Lung Cancer 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 @LeciaSequist @bensolomon1 @VanitaNoronha +@alexdrilon @JordiRemon @caliraf @JulienMazieres @TerriConneran

    Same topic pembrolizumab · 56 people#NSCLC535 views7 likes2 reposts0 replies
  26. Hidehito HORINOUCHI

    🔥OptiTROP-Lung06: Sac-TMT + pembrolizumab vs chemo + pembrolizumab in PD-L1-negative advanced NSCLC

    引用@

    🆙#ESMO26 Proffered Paper I: #LCSM Mets 🔥OptiTROP-Lung06: Sacituzumab Tirumotecan (Sac-TMT) Plus Pembrolizumab (P) Versus Chemotherapy (Chemo) Plus Pembrolizumab (P) as First-Line (1L) Treatment for PD-L1-Negative Advanced Non-Squamous (Nsq) NSCLC: Randomized Phase 3 Study 🎙️Dr. Caicun Zhou 🔢LBA66 🎯Met Primary Endpoint: BICR-PFS 15.0 vs 5.7mo (HR 0.49, p<0.0001; n=455) 🎯OS Immature, Favorable Trend (HR 0.58) 🎯Grade≥3 TEAEs 47.6% vs 60.6%; Grade≥3 Stomatitis 2.2% ☑️NCT06711900 🔗 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/272 @OncoAlert @Larvol @myESMO @IASLC

    Same topic pembrolizumab · 56 peopleOPTITROP-LUNG06#LCSM74 views3 likes2 reposts0 replies
  27. Dr Amol Akhade

    The benifit is same as if you give neo adjuvant pembrolizumab? - cross trial comparisons-

    引用@

    🚨 ESMO 2026 | INTErpath-001 (LBA1) - as data is released by Esmo 🔹 24-month RFS: 82.2% vs 70.0% HR 0.58 (95% CI 0.45–0.75); P<0.001 🔹 24-month DMFS: 88.5% vs 80.2% HR 0.62 (95% CI 0.45–0.85); P=0.002 🔹 Grade ≥3 adverse events: 23.6% vs 20.3% The trial randomized 1,137 patients with resected stage IIB–IV melanoma. Both arms received pembrolizumab; the experimental arm added an individualized mRNA neoantigen therapy. The key question now: will better recurrence control translate into an overall survival benefit? Looking forward to full dataset on day 2 . #ESMO26 @myESMO

    Same topic pembrolizumab · 56 people1451 views3 likes2 reposts1 reply
  29. Dr Rishabh Jain

    🚨 PD-L1 ≥50% NSCLC: Is pembrolizumab alone enough?

    引用@

    🚨 PD-L1 ≥50% in NSCLC: Is pembrolizumab alone enough? 🔥 PERSEE Phase III | #ESMO26 Concomitant publication in Annals of Oncology. Pembrolizumab + chemotherapy vs pembrolizumab alone: 📊 PFS: 16.1 vs 6.9 months (HR 0.56) 🎯 ORR: 77.5% vs 50.3% ⚠️ Grade ≥3 toxicity: 54% vs 19% OS: 50.2 vs 29.9 months (HR 0.77), not statistically significant. 💡 Verdict: Better disease control, but at a substantial toxicity cost. Is PD-L1 ≥50% alone sufficient to omit chemotherapy? @ESMO_open @myesmo @ASCO @oncoalert #ESMO26 #LungCancer

    Same topic pembrolizumab · 56 people118 views3 likes1 repost0 replies
  30. Hidehito HORINOUCHI

    🔥PERSEE: Pembrolizumab + chemo vs pembrolizumab monotherapy in PD-L1 ≥50% advanced NSCLC

    引用@

    🆙#ESMO26 Proffered Paper I: #LCSM Mets 🔥PERSEE (GFPC 01-2020): Pembrolizumab With or Without Platinum-Based Chemotherapy as First-Line Treatment in Advanced NSCLC With PD-L1 ≥50%, Phase 3 Trial 🎙️ @decroisette 🔢2614O 🎯Pembro-Chemo Improved BCR-PFS vs Pembro Alone 🎯PFS HR 0.56, mPFS 16.1 vs 6.9m 🎯OS HR 0.77 not significant; mOS 50.2 vs 29.9mo 🎯Grade≥3 TRAEs 53.8% vs 19.3% ☑️NCT04547504 🔗 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/272 @OncoAlert @Larvol @myESMO @IASLC

    Same topic pembrolizumab · 56 people#LCSM66 views2 likes2 reposts0 replies
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