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    DRUG:

    rilvegostomig (AZD2936)

    i
    Other names: AZD2936
    Company:
    AstraZeneca, Compugen, Xoma
    Drug class:
    PD1 inhibitor, TIGIT inhibitor
    Related drugs:
    5d
    MST01-AZN-05: PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, Presage Biosciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    10d
    Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (clinicaltrials.gov)
    P2, N=531, Recruiting, AstraZeneca | Trial completion date: Mar 2025 --> Aug 2026 | Trial primary completion date: Mar 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Combination therapy • Pan tumor • Metastases
    |
    Avastin (bevacizumab) • carboplatin • Imfinzi (durvalumab) • 5-fluorouracil • capecitabine • leucovorin calcium • datopotamab deruxtecan (DS-1062a) • saruparib (AZD5305) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    12d
    ARTEMIDE-01: A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=179, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    19d
    PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Presage Biosciences
    New P1 trial
    |
    Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    25d
    TROPION-Lung10: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=675, Not yet recruiting, AstraZeneca
    New P3 trial • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    TROP2 positive
    |
    Keytruda (pembrolizumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936)
    2ms
    MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov)
    P1, N=175, Active, not recruiting, AstraZeneca | Trial completion date: May 2023 --> Mar 2026
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • pemetrexed • oleclumab (MEDI9447) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • danvatirsen (AZD9150)
    3ms
    Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (clinicaltrials.gov)
    P2, N=357, Recruiting, AstraZeneca | Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2025 --> Jul 2026 | Trial primary completion date: Sep 2025 --> Jul 2026
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • Imfinzi (durvalumab) • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    3ms
    Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, AstraZeneca | N=180 --> 260 | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Immunomodulating • Metastases
    |
    Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    5ms
    TROPION-Lung04: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1; Phase classification: P1b --> P1 | N=232 --> 321
    Combination therapy • Enrollment change • Phase classification • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • PD-L1 IHC 28-8 pharmDx
    |
    carboplatin • Imfinzi (durvalumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    5ms
    ARTEMIDE-Bil01: Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (clinicaltrials.gov)
    P3, N=750, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • gemcitabine • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • rilvegostomig (AZD2936)
    5ms
    ARTEMIDE-01: A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=192, Recruiting, AstraZeneca | Trial primary completion date: Dec 2023 --> Jan 2026
    Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    5ms
    Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=240, Recruiting, AstraZeneca | N=80 --> 240
    Enrollment change • Metastases
    |
    CLDN18 (Claudin 18)
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • AZD0901 • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    6ms
    ARTEMIDE-01: A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=192, Recruiting, AstraZeneca | Trial completion date: Jul 2025 --> Jan 2026
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    6ms
    ARTEMIDE-Bil01: A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (clinicaltrials.gov)
    P3, N=750, Not yet recruiting, AstraZeneca
    New P3 trial • Combination therapy
    |
    cisplatin • gemcitabine • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • rilvegostomig (AZD2936)
    9ms
    TROPION-Lung04: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b; Trial completion date: Feb 2025 --> Jan 2026 | Trial primary completion date: Feb 2025 --> Jan 2026
    Combination therapy • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • PD-L1 IHC 28-8 pharmDx
    |
    carboplatin • Imfinzi (durvalumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    9ms
    Preliminary efficacy and safety of rilvegostomig (AZD2936), a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-pretreated advanced/metastatic non-small-cell lung cancer (NSCLC): ARTEMIDE-01 (ESMO 2023)
    Further investigation is ongoing in CPI-naïve cancer patients. Table: 1446P Safety and efficacy of rilvegostomig
    Clinical • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    rilvegostomig (AZD2936)
    10ms
    MERIDIAN: Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • CDKN2A negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    rilvegostomig (AZD2936)
    10ms
    Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, AstraZeneca | N=120 --> 180
    Enrollment change • Combination therapy • Immunomodulating • Metastases
    |
    Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    10ms
    MERIDIAN: Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC (clinicaltrials.gov)
    P2; Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • CDKN2A negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    rilvegostomig (AZD2936)
    11ms
    MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov)
    P1, N=175, Active, not recruiting, AstraZeneca | N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • pemetrexed • oleclumab (MEDI9447) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • danvatirsen (AZD9150)
    12ms
    Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=80, Recruiting, AstraZeneca | Trial completion date: Mar 2025 --> Feb 2026 | Trial primary completion date: Jun 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    12ms
    Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Immunomodulating • Metastases
    |
    Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    1year
    Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-experienced advanced/metastatic non-small-cell lung cancer (NSCLC): First report of ARTEMIDE-01. (ASCO 2023)
    In this interim analysis, AZD2936 showed an acceptable safety profile and preliminary antitumor activity in pts with advanced/metastatic NSCLC previously treated with standard therapy including CPIs. Further exploration of AZD2936 in CPI-naïve NSCLC pts, including a randomized dose optimization cohort is ongoing. Clinical trial information: NCT04995523.
    Clinical • PK/PD data • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    rilvegostomig (AZD2936)
    1year
    TROPION-Lung04: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b; Trial completion date: Mar 2026 --> Feb 2025
    Combination therapy • Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • PD-L1 IHC 28-8 pharmDx
    |
    carboplatin • Imfinzi (durvalumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    over1year
    ARTEMIDE-01: Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=192, Recruiting, AstraZeneca | N=147 --> 192
    Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    over1year
    TROPION-Lung04: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b; N=68 --> 232 | Trial completion date: Jun 2024 --> Mar 2026 | Trial primary completion date: Sep 2023 --> Dec 2024
    Combination therapy • Trial completion date • Trial primary completion date • Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • PD-L1 IHC 28-8 pharmDx
    |
    carboplatin • Imfinzi (durvalumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    over1year
    Preclinical studies support clinical development of AZD2936, a monovalent bispecific humanized antibody targeting PD-1 and TIGIT (SITC 2022)
    These preclinical results support the ongoing clinical development of AZD2936 in patients with cancer. Trial Registration NCT04995523
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule)
    |
    rilvegostomig (AZD2936)
    over1year
    ARTEMIDE-01: Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=147, Recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Jul 2025
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    over2years
    ARTEMIDE-01: A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=147, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)
    over2years
    ARTEMIDE-01: A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=147, Not yet recruiting, AstraZeneca
    Clinical • New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    rilvegostomig (AZD2936)