AstraZeneca has reached a crucial milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). This recommendation paves the way for a new treatment option for NSCLC patients across Europe.

Imfinzi, an immunotherapy drug, targets adults with NSCLC whose tumors express PD-L1 on ≥1% of tumor cells and who have not shown disease progression following platinum-based chemotherapy and radiation therapy (CRT). The positive CHMP opinion is a significant step forward in the regulatory process, potentially offering new hope to patients who have had limited treatment options for decades.

The recommendation for Imfinzi’s approval is based on the results of the phase III PACIFIC trial, which demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS). The trial included NSCLC patients regardless of their PD-L1 status, marking a comprehensive assessment of Imfinzi’s efficacy.

AstraZeneca has reported that the suggested label includes data reflecting a majority of the patients in the PACIFIC trial with a known PD-L1 status, underlining the drug’s broad potential impact. These findings have been crucial in securing CHMP’s support, with detailed post-hoc subgroup analyses emphasizing the drug’s benefits across different patient groups.

Following CHMP’s endorsement, the European Commission will make the final decision on Imfinzi’s approval, which will apply to all 28 EU member states plus Iceland, Norway, and Liechtenstein. This decision is eagerly anticipated by the medical community and patients alike, offering a potential breakthrough in the treatment landscape of NSCLC.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, expressed optimism about the CHMP’s positive opinion: “The CHMP positive opinion brings European patients closer to having a treatment following chemoradiation therapy. There have been no new treatments in this setting for decades. With approximately a third of European non-small cell lung cancer patients presenting with this stage of disease, we are excited by this potential new standard of care in this curative-intent setting.”

Imfinzi is a human monoclonal antibody that enhances the body’s immune response against cancer by inhibiting the PD-1/PD-L1 pathway. This mechanism prevents PD-L1 from binding with PD-1 and CD80 proteins, thus countering the tumor’s immune evasion tactics.

  AstraZeneca, CHMP, Committee for Medicinal Products for Human Use, Durvalumab, EMA approval, European Medicines Agency, Imfinzi, Immunotherapy, Lung cancer, NSCLC treatment, Oncology, PD-(L)1 inhibitor, Sean Bohen, United Kingdom