Gsk Plc · LSE:GSK

Gsk — ESMO 2026 Analyst briefing

49 slides from Gsk's conference presentation, Oct 27, 2026

  1. Slide 1: ESMO Analyst briefing

    27 October 2026 ESMO Analyst briefing gsk.com

  2. Slide 2: Cautionary statement regarding forward-looking statements

    Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t

  3. Slide 3: Speakers

    Speakers Nina Mojas Hesham Ahmed Rabie President, Global Abdullah SVP Global Product Strategy SVP, Global Head Product Strategy, Oncology R&D Oncology 3

  4. Slide 4: Agenda

    Agenda ESMO review Hesham Abdullah, Global Head, Oncology R&D Closing remarks Nina Mojas, President, Global Product Strategy Hesham, Nina and Ahmed Rabie, Head Oncology Global Product Q&A Strategy 4

  5. Slide 5: ESMO review

    ESMO review Hesham Abdullah, Global Head, Oncology R&D 5 gsk.com

  6. Slide 6: 2L+ SCLC: Emerging global data appear consistent with data generated in China

    2L+ SCLC: Emerging global data appear consistent with data generated in China n End points EMBOLD Pan-Tumour 101 18 ORR: 61% 2L+ SCLC: 8mg/kg q3w n End points ARTEMIS-008 461 - ORR 58.3% China phase III pivotal 2L+ SCLC - OS HR 0.46; mOS 18.5m 6

  7. Slide 7: Risvutatug Rezetecan vs Topotecan in Relapsed SCLC: Primary Results of Phase 3 ARTEMIS-008

    Risvutatug Rezetecan vs Topotecan in Relapsed SCLC: Primary Results of Phase 3 ARTEMIS-008 J. Wang1, L. Wang2, J. Duan1, H. Liu3, Q. Wang4, H. Wang2, L. Sun5, S. Huang6, Y. Huang7, F. Tong8, W. Zheng9, T. Chu10, Y. Fan11, D. Huang12, P. Zhang13, W. Guo14, B. Liu15, J. Zhou16, Q. Li17, Y. Dong18, Q.

  8. Slide 8: Primary Endpoint: OS

    Primary Endpoint: OS ➢ At this IA (DCO June 6, 2026), 77 (33.5%) OS events in Ris-Rez arm and 121 (52.4%) in Topotecan arm. ➢ With a median follow-up of 12.2 months, Ris-Rez demonstrated statistically significant and clinical meaningful survival benefit over topotecan. Ris-Rez Topotecan N=230 N=231

  9. Slide 9: Overall Survival – Benefit Across Pre-defined Subgroups

    Overall Survival – Benefit Across Pre-defined Subgroups Abbreviation: CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; N, number of participants; PD-1, programmed death receptor 1; PD-L1, programmed cell death ligand 1; VALG, Veterans Administration Lung Study

  10. Slide 10: Secondary Endpoints: PFS by BICR and investigator

    Secondary Endpoints: PFS by BICR and investigator BICR-assessed PFS Investigator-assessed PFS Ris-Rez Topotecan Ris-Rez Topotecan N=230 N=231 N=230 N=231 mPFS, months 7.2 3.0 mPFS, months 7.8 4.0 HR (95% CI) 0.33 (0.25, 0.42) HR (95% CI) 0.35 (0.28, 0.45) 59.9% 61.5% 28.5% 26.1% 30.5% 25.5% 5.3% 7.5

  11. Slide 11: Secondary Endpoints: ORR, DCR and DoR by BICR

    Secondary Endpoints: ORR, DCR and DoR by BICR • Ris-Rez demonstrated consistent benefit across secondary efficacy endpoints 70 ORR 58.3% 60 CR 1.7% (4) Best overall Response (%) 50 Ris-Rez Topotecan (N= 230) (N= 231) 40 30 ORR, % (95% CI) 58.3 (51.6, 64.7) 12.6 (8.6, 17.5) PR 20 ORR DCR, % (95% CI)

  12. Slide 12: Recent phase III SCLC datasets

    Recent phase III SCLC datasets Ris-Rez Tam-peli tarlatamab ARTEMIS-008 TAISHAN-302 USPI (China only) (China only) Global phase III 18.5 mo. 13.3 mo. 13.6 mo. mOS vs 9.4 for topotecan2 mOS vs 8.3 for plt-based chemo3 mOS vs 10.2 for topotecan1 HR:0.46, ∆3.9 mos, 9 mos follow-up HR:0.6, ∆5.3 mo.† HR:0

  13. Slide 13: Ris-Rez global pooled analysis: ILD rates ca4% with most events <Grade 3

    Ris-Rez global pooled analysis: ILD rates ca4% with most events <Grade 3 20% ILD incidence with Ris-Rez in patients with advanced solid tumours 15% 10% 5% 0% Tumour NSCLC + Other solid mCRPC SCLC Osteosarcoma type SCLC tumours Number of NSCLC n=44 n=362 n=50 n=230 n=48 patients SCLC n=152 Grade >=3

  14. Slide 14: Pooled analysis of interstitial lung disease cases

    ‘1068P_ Pooled analysis of interstitial lung disease cases among patients with advanced solid tumours who received risvutatug rezetecan monotherapy Jon Zugazagotia Frat, Patrica M.LoRusso?, L-Yuan Bat, Elena Eez!, Mara Eugenia Olmedo Garcia, Javer Garcia-Corbacho#, Sanjay Goo! [Antoine ttaano® Hye R

  15. Slide 15: Ris-Rez vs Gemcitabine and Docetaxel in Osteosarcoma: ARTEMIS-011 Primary Results

    LBA9 Risvutatug Rezetecan Versus Gemcitabine and Docetaxel in Heavily Pretreated Patients With Relapsed or Refractory Osteosarcoma: Primary Results From the Phase 3 ARTEMIS-011 Study L. Xie1; W. Yao2; Y. Hua3; W. Luo4; C. Tu5; J. Wang6; J. Chen7; B. Li8; D. Zhu9; X. Li10; Y. Xiao11; J. Ma12; H. Hu13

  16. Slide 16: ARTEMIS-011: A Multi-Centre, Open-Label, Randomised, Controlled Phase 3 Study

    ARTEMIS-011: A Multi-Centre, Open-Label, Randomised, Controlled Phase 3 Study Key Eligibility Criteria Study Treatment Primary Endpoint • Age ≥12 years Treatment until PD, toxicity, or withdrawal of • PFS by BICR per RECIST v1.1 consent Ris-Rez • Pathologically confirmed diagnosis of osteosarcoma 12

  17. Slide 17: Patient Demographics and Disease Characteristics

    Patient Demographics and Disease Characteristics • A total of 122 patients were randomised and received ≥1 dose of study drug • Median follow-up time was 7.1 months Ris-Rez Gemcitabine + Docetaxel (n = 80) (n = 42) Age Median (IQR), years 22.0 (17.5–33.0) 21.0 (17.0–37.0) 12 to <18 years, n (%) 20 (

  18. Slide 18: Primary Endpoint: BICR-assessed PFS with Ris-Rez vs Gemcitabine + Docetaxel

    Primary Endpoint: BICR-assessed PFS with Ris-Rez vs Gemcitabine + Docetaxel • At data cutoff date, there were 41 PFS events per BICR (41/80; 51%) in the Ris-Rez arm and 31 (31/42; 74%) in the Gemcitabine + Docetaxel arm • Ris-Rez demonstrated a statistically significant and clinically meaningful imp

  19. Slide 19: Tumour Response Assessed by BICR

    Tumour Response Assessed by BICR • BICR-assessed ORR and DCR were markedly higher with Ris-Rez vs Gemcitabine + Docetaxel • Median DOR by BICR was 7.6 months with Ris-Rez and was not reached in the Gemcitabine + Docetaxel arm (only one patient achieved PR) BICR-assessed ORR BICR-assessed DCR 20 Odds

  20. Slide 20: OS in R/R Osteosarcoma with Ris-Rez vs Gemcitabine + Docetaxel

    OS in R/R Osteosarcoma with Ris-Rez vs Gemcitabine + Docetaxel • OS data were immature but suggested a favourable trend towards an OS benefit with Ris-Rez • 10 events had occurred in each arm: 13% with Ris-Rez and 24% with Gemcitabine + Docetaxel • 17 patients* in the Gemcitabine + Docetaxel arm cro

  21. Slide 21: Safety Profile

    Safety Profile TRAEs reported in ≥20% of patients (in either treatment arm) Incidence, % WBC count decreased 14 80 40 43 30 63 29 52 Platelet count decreased 20 71 60 29 9 79 43 31 Lymphocyte count decreased 14 59 33 33 40 1 10 Vomiting 34 4 7 36 1 24 Hypoalbuminaemia 34 19 31 1 2 33 Decreased appet

  22. Slide 22: Mo-Rez in Platinum-Resistant Ovarian Cancer: Updated Results From BEHOLD-1

    Mocertatug Rezetecan (Mo-Rez) in Patients With Platinum-Resistant Ovarian Cancer (PROC): Updated Results With Longer Follow-Up From the Global BEHOLD-1 Study Vanda Salutari1, Stephanie Lheureux2, Myong Cheol Lim3, Isabelle Ray-Coquard4, Marloes G van Dongen5, William McKean6, Jung-Yun Lee7, Victor M

  23. Slide 23: BEHOLD-1 is a two-part, open-label Phase 1 study

    BEHOLD-1 is a two-part, open-label Phase 1 study Eligibility Criteria Phase 1a Dose Escalation Phase 1b Dose Optimisation/Expansion • Aged ≥18 years PROC • Histologically confirmed Advanced solid tumours * 2.8 mg/kg Q3W, (n~30–50) advanced solid tumour R 4.8 mg/kg Q3W, (n~30–50) • ECOG PS 0–2 1:1:1

  24. Slide 24: Baseline characteristics

    Baseline characteristics PROC Total (N=136) Age, median (range), years 60.5 (38, 79) 36% of patients received Race, n (%) White / Asian 112 (82) / 23 (17) >2 prior LOT Black or African American 1 (<1) BMI, median (range), kg/m2 25.8 (16, 50) ECOG PS, n (%) 0/1/2 68 (50) / 67 (49) / 1 (<1) Histology

  25. Slide 25: Mo-Rez was associated with rapid and deep responses at the 5.8 mg/kg Q3W dose

    Mo-Rez was associated with rapid and deep responses at the 5.8 mg/kg Q3W dose Mo-Rez 2.8 mg/kg Q3W (N=45) Mo-Rez 4.8 mg/kg Q3W (N=46) Mo-Rez 5.8 mg/kg Q3W (N=45) 30 P 30 30 D P P D D cORR* (95% CI): 36% (21.9, 51.2) cORR* (95% CI): 57% (41.1, cORR* (95% CI): 62% (46.5, 20 20 20 10 P D S S S S S S S

  26. Slide 26: Mo-Rez was associated with durable responses at 5.8 mg/kg Q3W

    Mo-Rez was associated with durable responses at 5.8 mg/kg Q3W Mo-Rez dose, mg/kg Q3W Kaplan-Meier plot of DoR 2.8 4.8 5.8 Mo-Rez 2.8 Mo-Rez 4.8 Mo-Rez 5.8 (N=45) (N=46) (N=45) mg/kg mg/kg mg/kg 100 90% (70, 100) Events, n (%) 10 (63%) 16 (62%) 11 (39%) 90 80 mDoR (IQR): 12.2 months (7.0, 12.7) Respo

  27. Slide 27: PFS was longest at the 5.8 mg/kg Q3W Mo-Rez dose

    PFS was longest at the 5.8 mg/kg Q3W Mo-Rez dose Mo-Rez dose, mg/kg Q3W Kaplan-Meier plot of PFS 2.8 4.8 5.8 Mo-Rez 2.8 Mo-Rez 4.8 Mo-Rez 5.8 (N=45) (N=46) (N=45) mg/kg mg/kg mg/kg 100 5.8 vs 4.8 mg/kg Events, n (%) 35 (78%) 30 (65%) 23 (51%) 90 80% (60, 90) HR: 0.66 (95% CI: 0.4, 1.1)‡ Progression-

  28. Slide 28: B7-H4 is widely expressed in PROC, enabling tumour selective payload delivery

    B7-H4 is widely expressed in PROC, enabling tumour selective payload delivery 96% of patients with PROC Responses were observed across a range of B7-H4 expression levels had B7-H4+ tumours (n=107/111)* at the 5.8 mg/kg dose (n=34; data cut-off Nov 2025)† Baseline B7-H4 expression was assessed via IH

  29. Slide 29: The most common treatment-related AEs were gastrointestinal and haematological

    The most common treatment-related AEs were gastrointestinal and haematological Mo-Rez 4.8 mg/kg Q3W (N=45) Mo-Rez 5.8 mg/kg Q3W (N=45) ILD/pneumonitis occurred in 9 Non-haematological patients (7%): 8 at 4.8 mg/kg Nausea 4 69 Nausea 4 87 and 1 (2%) at the 5.8 mg/kg dose† Fatigue 4 44 Fatigue 7 53 •

  30. Slide 30: Mo-Rez is being investigated in five global Phase 3 trials

    Mo-Rez is being investigated in five global Phase 3 trials spanning ovarian and endometrial cancer Mo-Rez vs SoC in 2L+ PROC NCT07286266 | GOG-3132 | ENGOT-ov98 | APGOT-OV24 Mo-Rez + BEV vs CT + BEV in PSOC NCT07684612 | GOG-3136 | ENGOT-ov99 | APGOT-OV19 Mo-Rez ± BEV vs active observation ± BEV as

  31. Slide 31: Clinical Complete Response with Dostarlimab Monotherapy in dMMR/MSI-H Rectal Cancer: AZUR-1

    Clinical Complete Response with Dostarlimab Monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer: First Results from the Global Registrational AZUR-1 Trial Andrea Cercek1, Jean-Baptiste Bachet2, Gunnar Folprecht3, Hideaki Bando4, Jenny Seligmann5, Naureen Starling6, María del Carmen Riesco Martí

  32. Slide 32: Background

    Background Locally advanced rectal cancer (LARC) has historically been treated with multimodal SOC1,2 • CRT and surgical approaches are associated with substantial toxicity, morbidity, and QoL burden3,4 • There has been growing interest in organ preservation strategies5,6 • While data are limited, c

  33. Slide 33: Baseline characteristics

    Baseline characteristics Dostarlimab monotherapy (N=154) Dostarlimab monotherapy (N=154) Age, median (range), years 61.5 (23−92) Disease stage at screening, n (%) ≥65, n (%) 65 (42) Stage II 22 (14) Sex, n (%) Stage III 132 (86) Clinical tumour stage, n (%) Male 95 (62) T1–T2 14 (9) Female 59 (38) T

  34. Slide 34: High rate of cCR12 observed with dostarlimab alone

    High rate of cCR12 observed with dostarlimab alone cCR with <12 mo follow-up (n=10) nCR (n=3) cCR with ≥12 mo follow-up (n=98) Non-cCR/pCR (n=34) pCR after dostarlimab monotherapy (n=12) Late cCR (n=8) cCR/pCR nCR cCR12 by INV PR SD 68% (98/144) N/A† PD cCR with ≥12 months follow-up* pCR post Non-cC

  35. Slide 35: Durable responses were observed in patients who achieved cCR

    Durable responses were observed in patients who achieved cCR Patients achieving cCR12 (INV) after dostarlimab alone (n=98) cCR at EOT response assessment 98% of cCRs were durable (n=92) with no recurrences (2 patients with cCR elected for surgery and had pCR) Time from enrolment to start of cCR12 fo

  36. Slide 36: cCR12 + pCR shows high overall benefit of dostarlimab alone

    cCR12 + pCR shows high overall benefit of dostarlimab alone cCR with <12 mo follow-up (n=10) nCR (n=3) cCR with ≥12 mo follow-up (n=98) Non-cCR/pCR (n=34) pCR after dostarlimab monotherapy (n=12) Late cCR (n=8) cCR12 (n=98) + pCR (n=12) cCR/pCR nCR cCR12 + pCR PR 76% SD (110/144) N/A† PD cCR with ≥1

  37. Slide 37: Image of complete response after Dostarlimab monotherapy

    Image of complete response after Dostarlimab monotherapy in LA dMMR/MSI-H rectal cancer Before Baseline evaluation after 2nd follow-up after Dostarlimab Dostarlimab completion Dostarlimab completion 37

  38. Slide 38: Safety profile consistent with prior studies of dostarlimab

    Safety profile consistent with prior studies of dostarlimab Dostarlimab median number of cycles 9 (range 2–9) N=154 Dostarlimab AEs (≥10% of patients) Gr1‒2 ≥Gr3 SAEs* Any causality related† Any dostarlimab-related AE, n (%) 98 (64) 15 (10) Any treatment emergent SAE, n (%) 31 (20) 8 (5) Pruritus 21

  39. Slide 39: Locally advanced rectal cancer is typically treated with multi-modal standard of care

    Locally advanced rectal cancer (LARC) is typically treated with multi-modal standard of care Current Standard of Care AZUR-1 data • Single agent dostarlimab for 9 cycles Chemotherapy Radiotherapy • cCR rate 68% per investigator • 76% cCR12 + pCR Surgery • 98% of cCRs were durable, with no recurrence

  40. Slide 40: Zidesamtinib in TKI-naive ROS1+ NSCLC: ARROS-1 efficacy and safety data

    Zidesamtinib in TKI-naive patients with advanced/metastatic ROS1+ NSCLC: ARROS-1 efficacy and safety data Alexander E. Drilon, Adrianus Johannes de Langen, Benjamin Besse, Aurélie Swalduz, Christina S. Baik, Elaine Shum, Tatsuya Yoshida, Geoffrey Liu, Stephen V. Liu, Julien Mazieres, Joel W. Neal, B

  41. Slide 41: ARROS-1: Patient Population

    ARROS-1: Patient Population ROS1 TKI-Naive Patient Characteristic Efficacy Population Data cut-off: 16 April 2026 All data shown as n (%) unless otherwise specified n = 94 Total Enrolled: N = 629 Age, median (range), years 59 (26, 87) Any ROS1+ solid tumor, any dose Female 55 (59%) Phase 1 + Phase 2

  42. Slide 42: ARROS-1: Objective Response in ROS1 TKI-Naive Patients with NSCLC

    ARROS-1: Objective Response in ROS1 TKI-Naive Patients with NSCLC Advanced ROS1+ NSCLC ROS1 TKI-Naive ± Prior Chemotherapy RECIST v1.1 by BICR (n = 94) ORR, % (n/N) a 94% (88/94) [95% CI] [87, 98] CR, % (n/N) b 15% (14/94) a Includes 1 single-timepoint PR pending confirmation in ongoing patient. b I

  43. Slide 43: ARROS-1: Duration of Response in ROS1 TKI-Naive Patients

    ARROS-1: Duration of Response in ROS1 TKI-Naive Patients with NSCLC Kaplan-Meier Plot of DOR ROS1 TKI-Naive ± Chemotherapy Advanced ROS1+ NSCLC ROS1 TKI-Naive 100 96% ± Prior Chemotherapy 94% Kaplan-Meier Estimate n = 87 86% % DOR ≥ 6 months 96% 75 Patients in response (%) [95% CI] [89, 99] % DOR ≥

  44. Slide 44: ARROS-1: Progression-Free Survival in ROS1 TKI-Naive Patients

    ARROS-1: Progression-Free Survival in ROS1 TKI-Naive Patients with NSCLC Kaplan-Meier Plot of PFS ROS1 TKI-Naive ± Chemotherapy Advanced ROS1+ NSCLC ROS1 TKI-Naive ± Prior Chemotherapy 100 95% 95% Kaplan-Meier Estimate n = 94 90% % PFS ≥ 6 months 95% Event-free probability (%) 75 [95% CI] [87, 98] %

  45. Slide 45: ARROS-1: CNS Activity in ROS1 TKI-Naive Patients with NSCLC

    ARROS-1: CNS Activity in ROS1 TKI-Naive Patients with NSCLC CNS Response-Evaluable ROS1 TKI-Naive ROS1 TKI-Naive CNS Response-Evaluable Population a ± Prior Chemotherapy 50 IC-PR IC-CR + Prior chemotherapy RECIST v1.1 by BICR n = 10 25 CNS target lesions Best % change in 0 IC-ORR, % (n/N) 100% (10/1

  46. Slide 46: ARROS-1: Safety in Advanced ROS1+ NSCLC

    ARROS-1: Safety in Advanced ROS1+ NSCLC TEAEs in ≥ 15% of TKI-Naive or TKI-Pretreated Patients with Advanced ROS1+ NSCLC Receiving Zidesamtinib 100 mg QD (N = 532) • Treatment-related AEs in ≥15% of patients (any grade; grade ≥3): Preferred Term Any Grade Grade ≥3 ‒ Peripheral edema (34%; 0.6%) Peri

  47. Slide 47: Closing remarks

    Closing remarks Nina Mojas, President Global Product Strategy 47 gsk.com

  48. Slide 48: ESMO and WCLC 2026 data summary

    ESMO and WCLC 2026 data summary Ris-Rez: 2L+ SCLC Ris-Rez: 2L+ SCLC Ris-Rez: r/r osteosarcoma EMBOLD pan-tumour 101 ARTEMIS-008 ARTEMIS-011 61% ORR 18.5m mOS vs 10.3m topotecan (HR 0.46) 0.33 PFS HR mPFS 5.5m vs 1.4m ARTEMIS-008 ORR 58% 54% reduction in risk of death for current standard of care Jem

  49. Slide 49: Q&A

    Nina Mojas Hesham Abdullah Ahmed Rabie President, Global SVP, Global Head SVP Global Product Q&A Product Strategy Oncology R&D Strategy, Oncology Klaas Bakker Eric Richards Richard Davidson MDL SVP Oncology MDL Ris-Rez Product Leadership Mo-Rez 49

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