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DRUG:

rilvegostomig (AZD2936)

i
Other names: AZD2936, AZD-2936, AZD 2936
Company:
AstraZeneca, Compugen, Xoma
Drug class:
PD1 inhibitor, TIGIT inhibitor
Related drugs:
2ms
New P3 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • rilvegostomig (AZD2936)
2ms
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • rilvegostomig (AZD2936)
3ms
New P2 trial
|
cisplatin • gemcitabine • albumin-bound paclitaxel • rilvegostomig (AZD2936)
3ms
New P3 trial • Combination therapy • Circulating tumor DNA
|
cisplatin • carboplatin • pemetrexed • etoposide IV • vinorelbine tartrate • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936)
3ms
Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific, for CPI-naïve Metastatic NSCLC with PD-L1 1-49% or ≥50% (IASLC-WCLC 2024)
Conclusions : In CPI-naïve patients, rilvegostomig showed a favourable safety profile and encouraging preliminary efficacy in those with PD-L1 TPS 1‒49% and PD-L1 TPS ≥50%. Data support 750 mg Q3W as the pivotal dose for registrational studies.
Clinical • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
VENTANA PD-L1 (SP263) Assay
|
rilvegostomig (AZD2936)
4ms
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 | Trial completion date: Nov 2025 --> Apr 2026 | Trial primary completion date: Nov 2025 --> Apr 2026
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
rilvegostomig (AZD2936)
5ms
New P3 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • rilvegostomig (AZD2936)
5ms
A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov)
P1/2, N=340, Recruiting, AstraZeneca | N=248 --> 340 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
puxitatug samrotecan (AZD8205) • rilvegostomig (AZD2936)
6ms
Enrollment change • IO biomarker • Metastases
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
6ms
Enrollment open • Trial primary completion date • 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)
7ms
Enrollment open
|
Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
7ms
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 • prednisone • leucovorin calcium • datopotamab deruxtecan (DS-1062a) • saruparib (AZD5305) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
7ms
Molecular residual disease (MRD) interception in locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC): MERIDIAN study. (ASCO 2024)
Rilvegostomig (AZD2936) is a monovalent bispecific TIGIT/PD-1 antibody that has shown acceptable safety in phase I studies, currently in phase III studies...Exploratory analyses include: ctDNA detection using other assays (HPV DNA, methylated ctDNA), ctDNA detection in part E and beyond W10 in part D, quality of life assessments (FACT-ICM, EORTC-HN43), health economics and radiomics. As of February 2024, 19 patients are recruited.
PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
RaDaR™ assay
|
rilvegostomig (AZD2936)
7ms
Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
rilvegostomig (AZD2936)
7ms
New P1 trial
|
Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
7ms
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)
9ms
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)
9ms
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)
9ms
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)
11ms
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)
11ms
Enrollment open
|
cisplatin • gemcitabine • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • rilvegostomig (AZD2936)
11ms
Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
rilvegostomig (AZD2936)
12ms
Enrollment change • Metastases
|
CLDN18 (Claudin 18)
|
5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • AZD0901 • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
1year
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)
1year
New P3 trial • Combination therapy
|
cisplatin • gemcitabine • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • rilvegostomig (AZD2936)
over1year
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)
over1year
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)
over1year
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)
over1year
Enrollment change • Combination therapy • Immunomodulating • Metastases
|
Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
over1year
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)
over1year
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)
over1year
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)
over1year
Enrollment open • Combination therapy • Immunomodulating • Metastases
|
Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
over1year
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)
over1year
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)
almost2years
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)
2years
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)
2years
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)
2years
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)
3years
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)
over3years
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)