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DRUG:

volrustomig (MEDI5752)

i
Other names: MEDI5752, MEDI-5752, MEDI 5752
Company:
AstraZeneca
Drug class:
PD1 inhibitor, CTLA4 inhibitor
Related drugs:
27d
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) (clinicaltrials.gov)
P3, N=800, Recruiting, AstraZeneca | Trial primary completion date: Feb 2027 --> Nov 2026
Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
volrustomig (MEDI5752)
2ms
eVOLVE-01: Volrustomig Priming Regimens Exploratory Phase II Platform Study (clinicaltrials.gov)
P2, N=120, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
carboplatin • pemetrexed • volrustomig (MEDI5752)
3ms
NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=490, Recruiting, AstraZeneca | Trial completion date: Dec 2029 --> May 2030 | Trial primary completion date: Dec 2029 --> May 2030
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • datopotamab deruxtecan (DS-1062a) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
3ms
Enrollment open • Combination therapy • Metastases
|
volrustomig (MEDI5752)
4ms
NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=490, Recruiting, AstraZeneca | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2028 --> Dec 2029
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • datopotamab deruxtecan (DS-1062a) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
5ms
New P2 trial • Combination therapy • Metastases
|
volrustomig (MEDI5752)
5ms
eVOLVE-01: Volrustomig Priming Regimens Exploratory Phase II Platform Study (clinicaltrials.gov)
P2, N=120, Not yet recruiting, AstraZeneca | Trial completion date: Jan 2028 --> Oct 2026
Trial completion date • Combination therapy
|
carboplatin • pemetrexed • volrustomig (MEDI5752)
6ms
FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=401, Active, not recruiting, MedImmune LLC | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • volrustomig (MEDI5752)
6ms
New P2 trial • Combination therapy
|
carboplatin • pemetrexed • volrustomig (MEDI5752)
7ms
Enrollment change • IO biomarker • Metastases
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
7ms
MEDI5752 in Japanese Patients With Advanced Solid Tumors. (clinicaltrials.gov)
P1, N=6, Active, not recruiting, AstraZeneca | Trial completion date: Mar 2024 --> Mar 2025
Trial completion date • Metastases
|
volrustomig (MEDI5752)
7ms
Bispecific immunotherapy MEDI5752 or volrustomig and cervical cancer. (PubMed, J Gynecol Oncol)
Only some phase I results in such development is published so far and no full report on this is available till now. This effort will try to record the facts and chain of events which actually occurred in inventing and bringing it in phase III trial.
Review • Journal
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
volrustomig (MEDI5752)
8ms
Enrollment open
|
Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
8ms
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)
8ms
New P1 trial
|
Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
9ms
FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=401, Active, not recruiting, MedImmune LLC | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • volrustomig (MEDI5752)
10ms
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)
10ms
MEDI5752 in Japanese Patients With Advanced Solid Tumors. (clinicaltrials.gov)
P1, N=6, Active, not recruiting, AstraZeneca | Trial primary completion date: Mar 2024 --> Aug 2023
Trial primary completion date • Metastases
|
volrustomig (MEDI5752)
10ms
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)
10ms
Enrollment change
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • datopotamab deruxtecan (DS-1062a) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
10ms
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
Enrollment open • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
volrustomig (MEDI5752)
12ms
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)
1year
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
|
volrustomig (MEDI5752)
1year
Enrollment open
|
Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • pemetrexed • volrustomig (MEDI5752)
1year
Phase 1b/2, open-label dose-escalation and -expansion study evaluating trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with HER2+ and HER2-low gastric cancer (GC): DESTINY-Gastric03 (DG-03). (ASCO-GI 2024)
Previously, confirmed ORRs of 50% and 43% were reported with T-DXd + 5-fluorouracil (5-FU) and T-DXd + capecitabine (Cap), respectively, in the second-line or later setting in part 1 of DG-03. The protocol was amended to add an additional arm in part 2 and a new part 3, which will investigate T-DXd in combination with a fluoropyrimidine and volrustomig (MEDI5752), a PD-1/CTLA-4 bispecific antibody, in pts with HER2+ and HER2-low (IHC 2+/ISH− or IHC 1+) GC...In arm F of part 2, pts with previously untreated HER2+ GC will be treated with T-DXd + investigator’s choice of 5-FU or Cap + pembrolizumab...Secondary endpoints include safety, duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and immunogenicity. Clinical trial information: NCT04379596.
Clinical • P1/2 data
|
HER-2 (Human epidermal growth factor receptor 2) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
HER-2 expression
|
Keytruda (pembrolizumab) • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • volrustomig (MEDI5752)
1year
Enrollment change • Metastases
|
CLDN18 (Claudin 18)
|
5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
1year
Enrollment open
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK rearrangement • PD-L1 negative • ROS1 rearrangement
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • volrustomig (MEDI5752)
1year
A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma (clinicaltrials.gov)
P1, N=179, Recruiting, MedImmune LLC | Phase classification: P1b --> P1 | Trial completion date: Dec 2025 --> Aug 2027 | Trial primary completion date: Dec 2025 --> Aug 2027
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Lenvima (lenvatinib) • Inlyta (axitinib) • volrustomig (MEDI5752)
1year
New P3 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
volrustomig (MEDI5752)
1year
NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=350, Recruiting, AstraZeneca | Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2028
Trial completion date • Trial primary completion date • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • datopotamab deruxtecan (DS-1062a) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
1year
New P3 trial • Combination therapy
|
Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • pemetrexed • volrustomig (MEDI5752)
1year
Enrollment open • Combination therapy • Metastases
|
volrustomig (MEDI5752)
1year
New P3 trial • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PGR expression
|
volrustomig (MEDI5752)
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
New P3 trial • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK rearrangement • PD-L1 negative • ROS1 rearrangement
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • volrustomig (MEDI5752)
over1year
Phase Ib multicenter study of trastuzumab deruxtecan (T-DXd) and immunotherapy with or without chemotherapy in first-line treatment of patients (pts) with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and HER2 overexpression (OE): DESTINY-Lung03 (ESMO 2023)
This trial is evaluating T-DXd alone or in combination with durvalumab (durva) or MEDI5752 (a PD-1/CTLA-4 bispecific antibody) with or without chemotherapy in pts with unresectable/metastatic, HER2-OE, nonsquamous NSCLC...In part 1 (enrollment completed), pts with disease progression after 1 or 2 lines of systemic therapy in the recurrent/metastatic setting receive T-DXd monotherapy or T-DXd + durva in combination with cisplatin, carboplatin, or pemetrexed...The primary endpoint is the frequency of adverse events (AEs) and serious AEs (SAEs) with T-DXd + durva + chemotherapy (part 1) or T-DXd + MEDI5752 ± chemotherapy (part 3). Secondary endpoints include confirmed objective response rate, duration of response, disease control rate, progression-free and overall survival, pharmacokinetics, and immunogenicity in all arms as well as the frequency of AEs and SAEs with T-DXd monotherapy (part 1).
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
EGFR mutation • HER-2 overexpression • EML4-ALK fusion • ALK fusion
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed • volrustomig (MEDI5752)
over1year
MEDI5752 (volrustomig), a novel PD-1/CTLA-4 bispecific antibody, in the first-line (1L) treatment of 65 patients (pts) with advanced clear cell renal cell carcinoma (aRCC) (ESMO 2023)
Volrustomig with lenvatinib is also being evaluated in 1L aRCC (NCT04522323). Table: 1883MO Efficacy DCO 25Jan2023 M750 M500 Total IMDC Total IMDC F I/P F I/P Response-evaluable, N 32 8 24 33 12 21 ORR, n (%) 15 (46.9) 2 (25) 13 (54.2) 15 (45.5) 7 (58.3) 8 (38.1) CR, n (%) 3 (9.4) 1 (12.5) 2 (8.3) 2 (6.1) 2 (16.7) 0 (0) DCR, n (%) 28 (87.5) 6 (75) 22 (91.7) 23 (69.7) 11 (91.7) 12 (57.1) Progressive disease, n (%) 4 (12.5) – – 8 (24.2) – – mPFS (95% CI), months 11.1 (4.5–NE) – – 9.9 (3.9–NE) – – Per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. CI, confidence interval; CR, complete response; DCR, disease control rate; F, favorable; IMDC, International Metastatic RCC Database Consortium; I/P, intermediate/poor; mPFS, median progression free survival; NE, not estimable.
Clinical • Metastases
|
PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Lenvima (lenvatinib) • volrustomig (MEDI5752)
over1year
Enrollment change • Combination therapy • Immunomodulating • Metastases
|
Avastin (bevacizumab) • cisplatin • gemcitabine • Lenvima (lenvatinib) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
over1year
Trial initiation date • Combination therapy • Metastases
|
volrustomig (MEDI5752)
over1year
New P2 trial
|
volrustomig (MEDI5752)
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)