A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved lung cancer survival rates, according to a new study.
This was compared to the use of chemotherapy alone for patients with operable non-small cell lung cancer.
The findings of the Phase III trial by researchers at The University of Texas MD Anderson Cancer Center were published in the New England Journal of Medicine.
The AEGEAN trial evaluated durvalumab given peri-operatively, meaning therapy is given both before and after surgery.
Participants received pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab.
Others received a pre-surgical placebo and chemotherapy followed by a post-surgical placebo.
AEGEAN was the first Phase III trial investigating peri-operative immunotherapy in patients with resectable non-small cell lung cancer to report positive outcomes.
“Our goal is to increase cures for lung cancer,” said principal investigator Dr John Heymach, chair of thoracic/head and neck medical oncology at MD Anderson Cancer Center.
“Throughout decades of research with post-surgical and pre-surgical chemotherapy, we only succeeded in increasing cures by around 5%.
“This one study alone has the potential to increase that percentage significantly, and we look forward to many more improvements going forward.”
Success rates
Of the patients receiving peri-operative durvalumab, 17.2% had a pathologic complete response compared to just 4.3% of those receiving chemotherapy alone.
At the first interim analysis of event-free survival, with a median follow-up of 11.7 months, the median event-free survival was 25.9 months in the placebo arm, but had not been reached in the durvalumab arm.
These data correspond to a 32% lower chance of patients experiencing disease recurrence, progression events or death with the immunotherapy-based treatment when compared to chemotherapy alone.
About four times as many patients treated with peri-operative durvalumab plus chemotherapy achieved a pathologic complete response when compared to those treated with chemotherapy alone.
Durvalumab, an immune checkpoint inhibitor targeting PD-L1, has previously been approved for treating patients with biliary tract cancer, liver cancer, small cell lung cancer and non-small cell lung cancer.
Currently, durvalumab is used for treating patients with locally advanced, un-resectable non-small cell lung cancer following definitive chemoradiotherapy, and for patients with metastatic non-small cell lung cancer in combination with tremelimumab and platinum-based chemotherapy.
For resectable non-small cell lung cancer, previous studies have shown some benefit from using post-surgical or pre-surgical immunotherapy, but Heymach explained the benefits have been modest so far.
MD Anderson is engaged in longstanding multidisciplinary efforts to use pre-surgical treatments to improve outcomes for patients.
Numerous clinical studies, such as the NEOSTAR and NeoCOAST trials, are evaluating pre-surgical immunotherapy and novel combinations to eliminate viable tumours before surgery and to reduce recurrence rates.