rilvegostomig (AZD2936) / AstraZeneca 
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  • ||||||||||  GEMINI-Hepatobiliary: A phase 2 study of novel first-line immuno-oncology-based treatments in patients with advanced hepatobiliary cancers. (Hall A; Poster Bd #: 163b) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_3916;    
    P2
    Early-phase studies have demonstrated the efficacy of volrustomig (volru; anti-PD-1/CTLA-4 bispecific humanized IgG1 monoclonal antibody [mAb]) in patients (pts) with non-small-cell lung cancer (NSCLC) and renal cell carcinoma, and of rilvegostomig (rilve; anti-PD-1/TIGIT bispecific humanized IgG1 mAb) in pts with NSCLC, along with manageable safety profiles...Pts will be treated with volru as monotherapy or in combination with bevacizumab or lenvatinib...Pts will be treated with gemcitabine + cisplatin with either rilve or volru...The study is currently recruiting at sites in the US, Asia, and Europe. GEMINI-Hepatobiliary master protocol design.
  • ||||||||||  rilvegostomig (AZD2936) / AstraZeneca
    Molecular residual disease (MRD) interception in locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC): MERIDIAN study. (Hall A; Poster Bd #: 433b) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_3572;    
    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.
  • ||||||||||  Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Dual immune checkpoint inhibition enhances the anti-tumor activity of trastuzumab deruxtecan in preclinical models (Section 3) -  Mar 5, 2024 - Abstract #AACR2024AACR_4155;    
    The anti-tumor activity of T-DXd in combination with volrustomig, a monovalent bispecific antibody targeting PD-1 and CTLA-4, was also assessed in hu-CD34+ NSG mice bearing HER2-low Caki-1 renal cell carcinoma tumors...Pharmacodynamic analysis revealed how the combination of T-DXd and PD-1/TIGIT inhibition increased tumoral NK cells (3.2-fold, P <0.001) and CD8+ T cells (3.8-fold, P <0.001) relative to vehicle. Consistent with findings in syngeneic models, the combination of T-DXd with a bispecific PD-1/CTLA-4 inhibitor also enhanced tumor growth inhibition in a humanised Caki-1 model (121%) compared to T-DXd alone (72%) (P <0.001).ConclusionsThese data provide insight into the clinical activity observed with T-DXd and provide scientific rationale for combination strategies with novel, bispecific IO agents targeting CTLA-4 or TIGIT in addition to the PD-1/PD-L1 axis.
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca
    Trial completion date, Metastases:  MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) -  Mar 2, 2024   
    P1,  N=175, Active, not recruiting, 
    Consistent with findings in syngeneic models, the combination of T-DXd with a bispecific PD-1/CTLA-4 inhibitor also enhanced tumor growth inhibition in a humanised Caki-1 model (121%) compared to T-DXd alone (72%) (P <0.001).ConclusionsThese data provide insight into the clinical activity observed with T-DXd and provide scientific rationale for combination strategies with novel, bispecific IO agents targeting CTLA-4 or TIGIT in addition to the PD-1/PD-L1 axis. Trial completion date: May 2023 --> Mar 2026
  • ||||||||||  volrustomig (MEDI5752) / AstraZeneca, rilvegostomig (AZD2936) / AstraZeneca
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Immunomodulating, Metastases:  Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (clinicaltrials.gov) -  Feb 15, 2024   
    P2,  N=260, Recruiting, 
    Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2025 --> Jul 2026 | Trial primary completion date: Sep 2025 --> Jul 2026 N=180 --> 260 | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca
    Enrollment change, Trial completion date, Trial primary completion date, Metastases:  MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) -  Jun 1, 2023   
    P1,  N=175, Active, not recruiting, 
    Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026 N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca
    Trial completion date, Trial primary completion date, Metastases:  MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) -  May 5, 2022   
    P1,  N=212, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026