Imfinzi Plus Chemotherapy Significantly Improves Pathologic Complete Response in Resectable NSCLC: Positive Interim Results from AEGEAN Phase III Trial

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News on June 30, 2022 /BioValleyBIOON/ -- AstraZeneca recently announced the antiPD-L1 Therapy Imfinzi (Generic Name: Durvalumab) for the Treatment of Resectable Non-Small CellLung Cancer（NSCLC）Positive High-Level Results from Planned Interim Analysis of AEGEAN Phase 3 Clinical Trial.

AEGEAN is a randomized, double-blind, multicenter, global Phase III trial conducted in patients with resectable stage IIA-IIIB (tumor ≥4cm or lymph node positive) NSCLC without EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression. The trial is evaluating the efficacy of Imfinzi in the perioperative setting. Perioperative treatment includes treatments before and after surgery, also known as neoadjuvant/adjuvant therapy. In this trial, 802 patients were randomly assigned to receive Imfinzi (a fixed dose of 1500mg every 3 weeks) plus chemotherapy or placebo plus chemotherapy for four cycles before surgery, followed by Imfinzi (every 4 weeks) or placebo for up to 12 cycles after surgery.

Data shows,In patients with resectable NSCLC, compared with neoadjuvant chemotherapy, Imfinzi combined with neoadjuvant chemotherapy increased the pathological complete response rate (pCR).StatisticsStatistically significant and meaningful improvement. In addition, there was also a significant improvement in major pathological response (MPR).The trial will continue as planned to assess the additional primary endpoint of event-free survival (EFS).

The safety and tolerability of adding Imfinzi in neoadjuvant chemotherapy are consistent with the known profile of this combination, and adding Imfinzi does not reduce the number of patients who can successfully undergo surgery compared to chemotherapy alone.

Globally, up to 30% of NSCLC patients are diagnosed early enough to undergo surgery with curative intent. However, only about 56-65% of stage II patients survive five years. For patients with stage III disease, this proportion drops to 24-41%.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said: "Early treatment for resectable lung cancer offers the best chance of a cure., however,Despite successful chemotherapy and surgery, the lung cancer of most patients will still recur within 5 years.Using Imfinzi before and after surgeryImmunity"The treatment is an exciting new strategy, and we hope that these early findings from the AEGEAN trial will improve survival rates for lung cancer patients in this potentially curative setting."

It is estimated that in 2020, approximately 2.2 million people globally wereDiagnosisFor lung cancer. Lung cancer is the leading cause of cancer death in both men and women, accounting for approximately one-fifth of all cancer-related deaths. Lung cancer is broadly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with 80-85% being NSCLC. Most NSCLC patients are diagnosed at an advanced stage of the disease, and about 25-30% of patients have resectable disease at the time of diagnosis. For patients with resectable tumors, despite complete tumor removal and adjuvant chemotherapy, the majority will eventually relapse.

Imfinzi (Yingfeifan, Durvalumab) is a humanized PD-L1 monoclonal antibody that can block the binding of PD-L1 to PD-1 and CD80, thereby blockingTumor ImmunologyEscape and release the suppressed immune response. To date, Imfinzi has been approved in multiple countries (including the United States, the European Union, China, Japan, etc.) for curative treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent chemoradiation therapy based on platinum drugs. Additionally, Imfinzi has also been approved in several countries (United States, European Union, China, Japan, etc.) for the treatment ofTreatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Currently, AstraZeneca is conducting several registration trials, mainly evaluating Imfinzi for the treatment of earlier-stage lung cancer, including resectable NSCLC (ADJUVANT BR.31 trial), unresectable NSCLC (PACIFIC-2, -4, -5, -8, -9 trials), and limited-stage small cell lung cancer (SCLC) (ADRIATIC trial). (Bioon.com)

Source of the original text:Imfinzi plus chemotherapy significantly improved pathologic complete response in AEGEAN Phase III trial in resectable non-small cell lung cancer