2022 World Conference on Lung Cancer (Posters)-P1.10-01. Phase 3 Study of Durvalumab Combined with Oleclumab or Monalizumab in Patients Phase 3 Study of Durvalumab Combined with Oleclumab or Monalizumab in Patients

P1.10-01. Phase 3 Study of Durvalumab Combined with Oleclumab or Monalizumab in Patients Phase 3 Study of Durvalumab Combined with Oleclumab or Monalizumab in Patients

Pdf Summary

This poster presents the design and rationale for the Phase 3 PACIFIC-9 study (NCT05221840), which aims to evaluate the efficacy and safety of combining durvalumab with either oleclumab or monalizumab compared to durvalumab alone in patients with unresectable Stage III non-small-cell lung cancer (NSCLC) who have completed chemoradiotherapy without disease progression. Durvalumab is an immunotherapy that blocks PD-L1, while oleclumab inhibits CD73 and monalizumab blocks NKG2A. Both these novel immunotherapies have shown promising results in preclinical and Phase 2 studies. The PACIFIC-9 study plans to recruit approximately 999 patients at 199 sites across multiple countries.<br /><br />The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival, objective response rate, duration of response, and time to first subsequent therapy or death, among others. The study will also assess the safety and tolerability of the combinations, as well as pharmacokinetics and immunogenicity.<br /><br />The PACIFIC study established durvalumab as the standard of care for patients with unresectable Stage III NSCLC who have not progressed after chemoradiotherapy. The PACIFIC-9 study aims to build upon this standard by exploring combination immunotherapy approaches to further improve patient outcomes. The scientific rationale for combining durvalumab with oleclumab or monalizumab in this patient population is based on their mechanisms of action and preclinical and clinical data demonstrating increased antitumor activity when these agents are combined with radiotherapy.<br /><br />The study is currently ongoing and is expected to be completed in May 2026. The results from the PACIFIC-9 study will provide valuable insights into the potential benefits of combining durvalumab with oleclumab or monalizumab in patients with unresectable Stage III NSCLC.

Asset Subtitle

Aarthi Gopinathan, United Kingdom

Meta Tag

Speaker Aarthi Gopinathan, United Kingdom

Topic Locally Advanced Non-small Cell Lung Cancer - Chemoradiotherapy and Radiotherapy

Keywords

PACIFIC-9 study

durvalumab

oleclumab

monalizumab

unresectable Stage III NSCLC

chemoradiotherapy

PD-L1

CD73

NKG2A

progression-free survival