Announcement of data from a study of pembrolizumab in adjuvant treatment of patients with stage IB-IIIA non-small cell lung cancer (NSCLC)

Recently, Merck, European Organization for Research and Treatment of Cancer ( EORTC ) and European Thoracic Oncology Platform ( ETOP ) announced their pivotal Phase III clinical trial KEYNOTE-091 (also known as EORTC-1416-LCG/ETOP-8-15-PEARLS ) research data
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The study was designed to evaluate the PD-1 inhibitor pembrolizumab versus placebo, with or without adjuvant chemotherapy, in patients with stage IB ( T ≥ 4 cm ) to stage IIIA non-small cell lung cancer ( NSCLC ) undergoing surgical resection ( Efficacy of adjuvant therapy after lobectomy or pneumonectomy)

Recently, Merck, European Organization for Research and Treatment of Cancer ( EORTC ) and European Thoracic Oncology Platform ( ETOP ) announced their pivotal Phase III clinical trial KEYNOTE-091 (also known as EORTC-1416-LCG/ETOP-8-15-PEARLS ) research data

According to data from the World Health Organization, there will be about 816,000 new lung cancer cases and about 715,000 deaths in China in 2020 .
Studies have shown that even after complete tumor resection, patients with non-small cell lung cancer still have the risk of postoperative recurrence, metastasis and second primary lung cancer.
More than 50% of tumor recurrence or metastasis occurred in the first 2 years after ^{surgery- -} .
Postoperative adjuvant therapy is an important treatment component for reducing recurrence, prolonging survival and improving quality of life after complete tumor resection of early and mid-stage non-small cell lung cancer, which can bring more clinical benefits to patients .

KEYNOTE-091 is a randomized, triple-blind, phase III clinical trial evaluating pembrolizumab, compared with placebo, with or without adjuvant chemotherapy as a follow-up to surgical resection (lobectomy or pneumonectomy) Differences in the efficacy and safety of adjuvant therapy in patients with stage IB - IIIA ( AJCC 7th edition TNM staging criteria) non-small cell lung cancer .

The primary endpoint of the study is disease-free survival ( DFS ) in the overall population and in those with high PD-L1 expression ( TPS ≥50% ) ; secondary endpoints of the study include overall survival ( OS ), lung cancer-specific survival ( LCSS ) .
The study enrolled 1177 patients with stage IB-IIIA NSCLC who achieved R0 resection and were randomized 1:1 to receive pembrolizumab ( 200 mg every 3 weeks , intravenous infusion, for 1 year or up to dosing)18 times) or placebo treatment

KEYNOTE-091 is a randomized, triple-blind, phase III clinical trial evaluating pembrolizumab, compared with placebo, with or without adjuvant chemotherapy as a follow-up to surgical resection (lobectomy or pneumonectomy) Differences in the efficacy and safety of adjuvant therapy in patients with stage IB - IIIA ( AJCC 7th edition TNM staging criteria) non-small cell lung cancer .
The primary endpoint of the study is disease-free survival ( DFS ) in the overall population and in those with high PD-L1 expression ( TPS ≥50% ) ; secondary endpoints of the study include overall survival ( OS ), lung cancer-specific survival ( LCSS ) .
The study enrolled 1177 patients with stage IB-IIIA NSCLC who achieved R0 resection and were randomized 1:1 to receive pembrolizumab ( 200 mg every 3 weeks , intravenous infusion, for 1 year or up to dosing)18 times) or placebo treatment

Data from the KEYNOTE-091 interim analysis released this time showed that KEYNOTE-091 met one of the dual primary endpoints of pembrolizumab as post-operative adjuvant therapy for patients with stage IB-IIIA non-small cell lung cancer, compared with placebo , a statistically and clinically significant improvement in DFS in the overall population (regardless of PD-L1 expression levels) .

Data from the KEYNOTE-091 interim analysis released this time showed that KEYNOTE-091 met one of the dual primary endpoints of pembrolizumab as post-operative adjuvant therapy for patients with stage IB-IIIA non-small cell lung cancer, compared with placebo , a statistically and clinically significant improvement in DFS in the overall population (regardless of PD-L1 expression levels) .

Patients who received pembrolizumab as adjuvant therapy had a median DFS of 53.
6 months, an improvement of nearly one year compared to the placebo group ( median DFS of 42.

At the same time, patients had a 24% lower risk of disease recurrence or death after surgery ( HR=0.

The data released by the online plenary meeting also means that regardless of the PD-L1 expression level, pembrolizumab may become a new option for postoperative adjuvant therapy for patients with early-stage lung cancer

Up to now, there are 8 indications of pembrolizumab approved by the China National Medical Products Administration ( NMPA ) , covering melanoma, lung cancer, esophageal cancer, head and neck cancer, colorectal cancer and esophageal cancer respectively .
The indication for pembrolizumab, with or without adjuvant chemotherapy, for postoperative adjuvant therapy in patients with stage IB to IIIA non-small cell lung cancer ( NSCLC ) has not been approved by the NMPA .

References:

References:

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IARC.
China Fact Sheet (2020) .

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Lu Shun, Wu Yilong, etc.
" Guidelines for Adjuvant Treatment After Complete Resection of Stage Ⅰ~ⅢB Non-Small Cell Lung Cancer ( 2021 Edition)" Chinese Medical Journal , April 27 , 2021 , Volume 101 , Issue 16

4.
Lu Shun, Wu Yilong et al.
" Guidelines for Adjuvant Treatment After Complete Resection of Stage Ⅰ~ⅢB Non-Small Cell Lung Cancer ( 2021 Edition)" Chinese Medical Journal , April 27 , 2021 , Volume 101 , Issue 16

4.
Lu Shun, Wu Yilong et al.
" Guidelines for Adjuvant Treatment After Complete Resection of Stage Ⅰ~ⅢB Non-Small Cell Lung Cancer ( 2021 Edition)" Chinese Medical Journal , April 27 , 2021 , Volume 101 , Issue 16

5.
Here, DFS is defined as the time from randomization to disease recurrence and distant metastasis (including second primary non-small cell lung cancer or other malignancies) or death from any cause, whichever occurs first .

5.
Here, DFS is defined as the time from randomization to disease recurrence and distant metastasis (including second primary non-small cell lung cancer or other malignancies) or death from any cause, whichever occurs first .

6.
Here, LCSS is defined as the time from randomization to the date of death due to lung cancer

6 , here, LCSS is defined as the time from randomization to the date of death due to lung cancer Leave a comment here