AstraZeneca's Imfinzi adds indication for adjuvant therapy before and after lung cancer surgery

AstraZeneca Korea said Friday that it had received approval from the Ministry of Food and Drug Safety (MFDS) for an expanded indication of Imfinzi (durvalumab) as pre- and post-operative adjuvant therapy for patients with resectable non-small cell lung cancer (NSCLC).

The approval allows Imfinzi to be used in combination with platinum-based chemotherapy before surgery and as monotherapy after surgery in adult patients with resectable (tumor >4 cm and/or lymph node positive) NSCLC without EGFR mutation or ALK translocation.

Imfinzi was initially approved in 2018 for unresectable locally advanced stage 3 NSCLC and became available with reimbursement in April 2020.

The recent indication expansion is based on results from the phase 3 AEGEAN trial, which evaluated the efficacy of Imfinzi as pre- and postoperative adjuvant therapy in adult patients with resectable early-stage (stage 2A or stage 3B) NSCLC without EGFR (epidermal growth factor receptor) mutations or ALK (anaplastic lymphoma kinase) rearrangements.

In an interim analysis, pre-and postoperative adjuvant Imfinzi reduced the risk of disease progression, recurrence or death by 32 percent compared to chemotherapy alone (HR 0.68; 95 percent CI 0.53-0.88; p=0.004), with a pathologic complete response (pCR) rate of 17.2 percent in the preoperative adjuvant arm (95 percent CI 8.7-17.6), about 13 percentage points higher than preoperative adjuvant chemotherapy alone (4.3 percent).

No new safety concerns were observed in this study following pre- or post-adjuvant Imfinzi administration. The safety profile of adding Imfinzi to preoperative chemotherapy was consistent with the results observed with each agent individually, and the proportion of patients completing surgery was similar between the two arms.

With this approval, Imfinzi is available in Korea for five indications, including unresectable (stage 3) locally advanced NSCLC with no disease progression after concurrent platinum-based chemoradiotherapy; resectable (stage 2A-3B) NSCLC without known EGFR mutations or ALK translocations; expanded-stage small cell lung cancer; locally advanced or metastatic biliary tract cancer; and advanced or unresectable hepatocellular carcinoma.

“Early-stage resectable NSCLC has a high recurrence rate even after chemotherapy and surgical resection. The results of the AEGEAN study and this approval by the MFDS confirm the clinical value of Imfinzi as an adjuvant pre- and postoperative therapy for early-stage NSCLC,” said Yang Mi-sun, director of the Oncology Business Unit at AstraZeneca Korea. “As an approved immunotherapy and standard of care for treating unresectable stage 3 NSCLC that has not progressed after chemotherapy and radiotherapy, we look forward to helping more patients benefit from the therapeutic value of Imfinzi in clinical practice in Korea.”