The European Commission (EC) has granted approval for AstraZeneca’s Imfinzi plus chemotherapy for treating resectable non-small cell lung cancer (NSCLC) in adults. NSCLC is the most prevalent form of lung cancer.
This approval in the European Union is intended for individuals who are at high risk of recurrence and do not have anaplastic lymphoma kinase (ALK) rearrangements or epidermal growth factor receptor (EGFR) mutations.
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The decision follows the Committee for Medicinal Products for Human Use’s positive opinion and is anchored in the outcomes from the pivotal randomised Phase III AEGEAN trial.
The AEGEAN trial’s interim analysis demonstrated a 32% decrease in the recurrence, disease progression and mortality risk in subjects treated with the human monoclonal antibody Imfinzi-based perioperative regimen against only neoadjuvant chemotherapy.
The final analysis of pathologic complete response (pCR) revealed that the regimen achieved a 17.2% pCR rate against 4.3% with chemotherapy alone.
Imfinzi was found to be well-tolerated and consistent with the combo’s known safety profile, with no safety concerns identified.
AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson stated: “Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable NSCLC, enabling more patients to access this important immunotherapy-based regimen.”
The latest decision extends the antibody’s reach, which is already approved in the US, China and other regions, with ongoing reviews in Japan and elsewhere.
Since its first approval in May 2017, the antibody has been administered to more than 374,000 subjects.
It is a part of a wide development programme, being evaluated as both monotherapy and as conjunction therapy for small cell lung cancer (SCLC), NSCLC, and for gastrointestinal, bladder and breast cancers, among others.
The EC previously approved AstraZeneca and Daiichi Sankyo’s Enhertu for use as a single agent in treating adults with unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2 low or ultralow breast cancer.
