MHRA Approves AstraZeneca's Imfinzi Regimen for Resectable Lung Cancer

AstraZeneca (AZ) has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Imfinzi (durvalumab) regimen in a specific group of adults with resectable non-small cell lung cancer (NSCLC). This approval in Great Britain permits the use of the anti-PDL1 antibody in combination with platinum-based chemotherapy before surgery (as a neoadjuvant treatment) and as a standalone treatment after surgery (as an adjuvant monotherapy).

The newly approved regimen is designated for patients with resectable NSCLC who do not have known mutations in the epidermal growth factor receptor, ALK rearrangements, or other aberrations. The MHRA’s decision expands Imfinzi’s approval in Great Britain to cover both resectable and unresectable NSCLC, based on positive outcomes from the AEGEAN trial, a late-stage clinical study.

Findings from the AEGEAN trial underscore the efficacy of the Imfinzi regimen. Patients treated with this combination experienced a 32% reduction in the risk of recurrence, disease progression, or death compared to those who received neoadjuvant chemotherapy alone. Furthermore, the combination treatment achieved a pathologic complete response rate of 17.2%, significantly higher than the 4.3% observed in patients receiving only neoadjuvant chemotherapy.

Lung cancer remains a major health challenge in the UK, accounting for 21% of all cancer-related deaths. Non-small cell lung cancer (NSCLC) represents up to 85% of these diagnoses. David Harland, head of oncology medical affairs at AZ UK, hailed the MHRA's approval as a significant advancement in the treatment of resectable NSCLC, noting that it "opens a new chapter" in patient care. Harland emphasized AZ’s commitment to collaborating with the National Institute for Health and Care Excellence and NHS England to facilitate swift access to this new treatment for patients.

Dr. John Conibear, clinical director of thoracic oncology at Barts Cancer Centre, echoed Harland’s enthusiasm. He highlighted the MHRA's decision as a recognition of a meaningful clinical improvement for patients with resectable NSCLC, stressing the urgent need for new treatment options that can enhance long-term survival.

The MHRA's approval comes shortly after another milestone for Imfinzi and AZ’s PARP inhibitor Lynparza (olaparib). The European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended these drugs for the treatment of certain endometrial cancer patients. Specifically, the committee endorsed Imfinzi in combination with chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi, for patients with mismatch repair proficient primary advanced or recurrent endometrial cancer. Additionally, Imfinzi plus chemotherapy, followed by Imfinzi alone, was recommended for those with mismatch repair deficient disease.