Imfinzi Plus Neoadjuvant Chemo May Improve Surgery for Patients With NSCLC

Treatment with perioperative Imfinzi (durvalumab) plus neoadjuvant chemotherapy may improve surgery outcomes for patients with resectable non-small cell lung cancer (NSCLC), according to findings from a trial presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer in Singapore.

Imfinzi is a type of monoclonal antibody and immune checkpoint inhibitor that blocks and binds to the protein PD-L1, which helps the immune cells kill cancer cells more effectively, as defined by National Institute of Cancer. The term perioperative refers to the period around surgery, which includes the time from when a patient goes to the hospital for surgery until the time the patient returns home, as also defined by National Institute of Cancer.

NSCLC is a group of lung cancers, which includes three types: adenocarcinoma (most common), squamous cell carcinoma and large cell carcinoma. NSCLC is the most common group of lung cancers between the two main types, including small-cell lung cancer and NSCLC, according to National Institute of Cancer. Resectable NSCLC refers to the process of surgically removing the cancerous tumor.

The phase 3 trial, AEGEAN, included 802 patients who had not previously received treatment and had resectable NSCLC, according to a press release from IASLC. Patients in this double-blind (neither the researchers nor patients know the treatment patients receive in order to reduce biases) trial either received perioperative Imfinzi in addition to neoadjuvant (treatment to shrink tumor before surgery) chemotherapy or a placebo treatment.

Researchers from the study analyzed the efficacy in the modified intent-to-treat population, in which there were 740 total patients with no EGFR (estimated glomerular filtration rate) mutations or ALK gene rearrangements. Of the 740 total patients, there were 366 patients in the Imfinzi group and 374 patients in the placebo group.

“The AEGEAN trial demonstrated a clinically meaningful improvement in event-free survival (EFS) with the addition of perioperative durvalumab to neoadjuvant chemotherapy, alongside significantly improved pathological complete response (pCR) and major pathological response (MPR),” Dr. Tetsuya Mitsudomi, from the division of thoracic surgery, department of surgery at Kindai University Faculty of Medicine in Osaka-Sayama, Japan, said in a press release.

“Understanding surgical outcomes can further inform the use of this treatment and is an important consideration for patients and physicians,” she said.

In this modified intent-to-treat population, 80.6% of patients in the Imfinzi group and 80.7% of patients in the placebo group underwent surgery, as reported in the press release. Regarding patients who completed surgery, there were 77.6% of patients in the Imfinzi group and 76.7% in the placebo group. The press release also reported that some patients canceled surgery (6.8% vs. 7.8%, respectively) or did not complete surgery (1.4% vs. 2.1%) because of disease progression.

For patients who underwent surgery, the press release noted that 17.3% in the Imfinzi group and 22.2% of patients in the placebo group delayed their surgeries, most commonly because of logistical reasons, such as scheduling issues, which 9.5% and 12.3% of patients specifically reported.

According to the findings from the press release, the median time from the last dose of neoadjuvant treatment until surgery was 34 days in both groups.

The types of planned surgery allowed in the trial included lobectomy (removing a whole section of the lung), sleeve resection (removing a lung tumor in a section of the lung and part of the main airway) and a bilobectomy (removing two sections of the lung).

Among the patients who underwent surgery, the researchers found that 49.2% of patients from the Imfinzi group and 50.7% of patients in the placebo groups had open procedures, whereas 49.2% and 47% underwent minimally invasive procedures, respectively. According to the press release, there was a high proportion of patients in both groups who had R0 resection, which is when no microscopic tumor remains in the tumor bed (94.7% vs. 91.3%, respectively).

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