volrustomig (MEDI5752) / AstraZeneca - LARVOL DELTA

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=454 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Aug 2026 ➔ Oct 2027 | Trial primary completion date: Aug 2026 ➔ Oct 2027

Monotherapy • Pan tumor • Trial completion date • Trial primary completion date • Biliary Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

eVOLVE-02: Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=257 | Recruiting | Sponsor: AstraZeneca | N=110 ➔ 257

Enrollment change • Monotherapy • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy from a first-in-human study of volrustomig, a novel PD-1/CTLA-4 bispecific antibody. (PubMed, Clin Cancer Res) - P1 | "These results support further development of volrustomig as monotherapy and in combination regimens, with phase 3 trials ongoing."

First-in-human • Journal • P1 data • PK/PD data • Dermatology • Endocrine Disorders • Oncology • Pruritus • CTLA4 • PD-1

Volrustomig, a novel bispecific PD-1/CTLA-4 monoclonal antibody, as single-agent first-line (1L) therapy for unresectable pleural mesothelioma (PM): Substudy 5 of the eVOLVE-02 phase II study (ELCC 2026) - P2 | "Nivolumab + ipilimumab and pembrolizumab + pemetrexed + platinum chemotherapy showed improved survival vs chemotherapy alone, with greater benefit in non-epithelioid compared to epithelioid PM. eVOLVE-02 is recruiting patients; 3 substudies are ongoing in cervical cancer and head and neck squamous cell carcinoma. Substudy 5 enrolment is planned at sites in 8 countries/regions: Australia, Canada, China, Germany, Italy, Taiwan, UK, and USA."

Bispecific • Clinical • P2 data • Lung Cancer • Solid Tumor • CTLA4

Phase Ib study of first-line (1L) trastuzumab deruxtecan (T-DXd) plus volrustomig in patients (pts) with HER2-overexpressing (HER2-OE) non-small cell lung cancer (NSCLC): DESTINY-Lung03 (DL-03) part 5 (ELCC 2026) - P1 | "Primary endpoints: adverse events (AEs; including serious AEs) and AEs of special interest. Secondary endpoints: investigator-assessed confirmed objective response rate, duration of response, disease control rate, and progression-free survival per RECIST 1.1; and overall survival."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • TIGIT

GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=163 | Recruiting | Sponsor: AstraZeneca | N=240 ➔ 163 | Trial completion date: Sep 2027 ➔ May 2029 | Trial primary completion date: Jul 2026 ➔ Nov 2027

Enrollment change • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=271 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Mar 2024 ➔ Nov 2023 | Trial primary completion date: Mar 2024 ➔ Nov 2023

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=275 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Feb 2023 ➔ Jun 2023 | Trial primary completion date: Feb 2023 ➔ Jun 2023

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=366 | Recruiting | Sponsor: MedImmune LLC | N=271 ➔ 366 | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Nov 2023 ➔ Mar 2024

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=401 | Active, not recruiting | Sponsor: MedImmune LLC | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Dec 2025

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=261 | Active, not recruiting | Sponsor: MedImmune LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=261 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=366 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Mar 2024 ➔ Apr 2025 | Trial primary completion date: Mar 2024 ➔ Apr 2025

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=261 | Recruiting | Sponsor: MedImmune LLC | N=188 ➔ 261

Enrollment change • IO biomarker • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=261 | Recruiting | Sponsor: MedImmune LLC | Active, not recruiting ➔ Recruiting

Enrollment open • IO biomarker • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=401 | Active, not recruiting | Sponsor: MedImmune LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=188 | Recruiting | Sponsor: MedImmune LLC | N=272 ➔ 188

Enrollment change • IO biomarker • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=396 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Jan 2026 ➔ Apr 2025 | Trial primary completion date: Jan 2026 ➔ Apr 2025

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=188 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Oct 2022 ➔ Jul 2022 | Trial primary completion date: Oct 2022 ➔ Jul 2022

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=271 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: May 2023 ➔ Nov 2023 | Trial primary completion date: May 2023 ➔ Nov 2023

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=271 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Nov 2023 ➔ Mar 2024

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=275 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Jun 2023 ➔ Sep 2022 | Trial primary completion date: Jun 2023 ➔ Sep 2022

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=263 | Recruiting | Sponsor: MedImmune LLC

IO biomarker • New P1 trial • Solid Tumor

FTIH: A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=366 | Recruiting | Sponsor: MedImmune LLC | Trial completion date: Apr 2025 ➔ Jan 2026 | Trial primary completion date: Apr 2025 ➔ Jan 2026

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - P1 | N=175 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: May 2023 ➔ Mar 2026

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1