AstraZeneca’s Imfinzi, in combination with chemotherapy, has received European Commission (EC) approval to treat a type of non-small cell lung cancer (NSCLC).
The regimen is indicated for at-risk adults with NSCLC, without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), based on results from the AEGEAN clinical trial.
AstraZeneca oncology haematology business unit executive vice president Dave Fredrickson said: “Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable non-small cell lung cancer, enabling more patients to access this important immunotherapy-based regimen.
“This new indication builds on the established role of Imfinzi in unresectable disease and underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.”
In the study, the Imfinzi-based regimen showed a 32% reduction in the risk of recurrence, progression, or death compared to neoadjuvant chemotherapy alone.
The pathologic complete response (pCR) rate was 17.2% for patients taking Imfinzi plus neoadjuvant chemotherapy before surgery, compared to 4.3% for chemotherapy alone.
In the study, Imfinzi was generally well-tolerated, with no new safety signals observed in neoadjuvant and adjuvant settings.
Imfinzi is already approved in the US, China, and other countries for this indication based on the AEGEAN results, with regulatory applications under review in several other countries.
AEGEAN Steering Committee head and trial investigator Martin Reck said: “Today’s approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable non-small cell lung cancer, who have historically faced high rates of recurrence and a poor prognosis.
“When added to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.”
In a separate development, AstraZeneca and Daiichi Sankyo’s Enhertu has been approved in the EU as a monotherapy for adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.
The approval is based on results from the DESTINY-Breast06 Phase 3 trial.
In the study, Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer.
The median progression-free survival (PFS) was 13.2 months for Enhertu compared to 8.1 months for chemotherapy.
With the EU approval in place, AstraZeneca will make a $125m milestone payment to Daiichi Sankyo.
Enhertu is already approved in over 75 countries for patients with HER2-low metastatic breast cancer who have received prior chemotherapy or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Dave Fredrickson added: “This approval underscores the importance of testing metastatic breast cancer tumours for any IHC staining to identify patients with HR-positive, HER2-low or HER2-ultralow disease who may be eligible for Enhertu once sustained responses are no longer achieved with endocrine-based therapy.”
Daiichi Sankyo president, CEO and oncology business global head Ken Keller said: “Enhertu continues to evolve what is possible with breast cancer treatment, becoming the first HER2-directed medicine approved in the EU for patients with HR-positive metastatic breast cancer with HER2-low or HER2-ultralow expression following endocrine therapy.
“Today’s approval expands the use of Enhertu to now include an earlier treatment setting of HER2-low metastatic breast cancer and broadens the patient population eligible for treatment to those with HER2-ultralow disease.”
