Phase III clinical study CheckMate -816 confirmed: preoperative use of Opdivo combined with chemotherapy significantly improved event-free survival in patients with non-small cell lung cancer

Recently, Bristol-Myers Squibb (NYSE: BMY) announced data on the primary endpoint of the Phase III clinical study CheckMate -816, event-free survival (EFS)
.
The results showed that compared with chemotherapy alone, patients with resectable non-small cell lung cancer (NSCLC) who received 3 courses of Opdivo combined with chemotherapy before surgery could significantly improve the EFS benefit of patients
.
Patients were randomized, and at a minimum follow-up of 21.
0 months, patients who received nivolumab plus chemotherapy before surgery had a 37% reduction in the risk of disease recurrence, progression, or death (HR 0.
63; 97.
38% confidence interval [CI]: 0.
43-0.
91; p=0.
0052)
.
The median EFS for patients in the nivolumab-chemotherapy group was 31.
6 months, compared with 20.
8 months for patients in the chemotherapy-alone group
.
In addition, although the current survival data are immature and the analysis did not reach statistical boundaries, a favorable overall survival (OS) early benefit was observed in the nivolumab-chemotherapy group (HR 0.
57; 99.
67%).
Confidence interval [CI]: 0.
30-1.
07)
.
At two years of follow-up, survival was 83% for patients receiving neoadjuvant nivolumab plus chemotherapy and 71% for those receiving chemotherapy alone
.
Follow-up will continue to follow up OS and do further analysis
.
CheckMate -816 is the first phase III clinical study to demonstrate that an immune-based combination therapy can significantly improve EFS and pathological complete response (pCR) rates in patients with non-small cell lung cancer in the neoadjuvant phase
.
The EFS data were first announced at the 2022 American Association for Cancer Research (AACR) Annual Meeting Neoadjuvant and Perioperative Immunotherapy Clinical Research Plenary Session from 23:15 on April 11, 2022 to 01:15 on April 12, 2022 (Beijing time).
Abstract #CT012) and published concurrently in the New England Journal of Medicine
.
Dr Nicolas Girard, Investigator of CheckMate -816, Professor and Director of the Institut Curie-Monsouris Thoracic Institute in Paris, said: "Although some patients with resectable non-small cell lung cancer have the potential to be cured, most patients still face a high rate of postoperative recurrence.
Therefore, we need effective systemic treatment options to prevent this from happening
.
The results of CheckMate -816 demonstrate for the first time that an immunotherapy-based combination regimen, neoadjuvant therapy, compared with chemotherapy alone, can benefit these patients.
There is a clear and significant benefit
.
In this study, we first observed an improvement in pathological complete response rates in patients, and now an improvement in event-free survival, along with positive outcomes in overall survival.
We are working toward the ultimate goal of curing patients, and these data suggest that nivolumab
in combination with chemotherapy has the potential to deliver better long-term survival outcomes for patients
.
” In this study, nivolumab was combined with chemotherapy The safety profile as neoadjuvant therapy was consistent with previous studies, and no new safety signals were observed when EFS was analyzed
.
The incidence of grade 3-4 treatment-related adverse events in the nivolumab plus chemotherapy group was similar to that in the chemotherapy alone group compared with chemotherapy alone (34% vs 37%)
.
In addition, the incidence of grade 3-4 surgery-related adverse events was similar in the two groups (nivolumab plus chemotherapy: 11%, chemotherapy alone: ​​15%)
.
Eighty-three percent of patients in the nivolumab-chemotherapy group underwent surgery, compared with 75% in the chemotherapy-alone group
.
"Surgery remains the cornerstone of cure for patients with non-small cell lung cancer," said Jonathan Spicer, CheckMate -816 investigator, associate professor of surgery at McGill University, and attending physician in thoracic and upper gastrointestinal surgery at McGill University Health Center Montreal General Hospital
.
Anti-combination chemotherapy as neoadjuvant therapy enables shorter, less invasive, and less extensive surgical procedures without increasing complications or adverse events, which are important to thoracic surgeons and their patients
.
The benefits of surgical outcomes, coupled with improved patient survival outcomes, are expected to revolutionize the way surgeons and oncologists collaborate in the management of patients with resectable NSCLC
.
"Immunotherapy has ushered in a new era of advanced cancer treatment, changing survival expectations for patients with lung cancer and many other tumor types," said Abderrahim Oukessou, Ph
.
In recent years, with the in-depth understanding of the immune system and cancer biology, we continue to explore the use of immunotherapy in the neoadjuvant, adjuvant and perioperative period
.
Data from the CheckMate -816 study, including encouraging early results in overall survival, reaffirms the importance of immunotherapy research in early stage cancer, and we look forward to continuing to see what these scientific studies can bring to patients and their families real benefit
.
Based on the EFS and pCR results of CheckMate -816, the US FDA approved nivolumab in combination with platinum-based doublet chemotherapy (one cycle every three weeks for a total of three cycles) in March 2022 for neoadjuvant treatment of tumors ≥ Adult patients with 4cm or node-positive resectable NSCLC
.
Other national health regulators around the world are also reviewing the new drug marketing application
.
In the field of non-metastatic non-small cell lung cancer, Bristol-Myers Squibb and its partners are jointly exploring immunity The use of treatment in the neoadjuvant, adjuvant and perioperative period, and in combination with chemoradiotherapy.
The
use of tumor immunotherapy in the neoadjuvant phase has a dual scientific rationale: First, when immunotherapy is used, the presence of the tumor may The immune response is stronger, which is expected to make the treatment against the primary tumor more effective
.
Second, tumor immunotherapy will have the opportunity to clear cryptic micrometastases
.
To date, Opdivo has been used as a neoadjuvant or adjuvant therapy in four tumor types.
demonstrated improved efficacy in lung, bladder, esophageal/gastroesophageal junction cancers, and melanoma
.
Bristol-Myers Squibb would like to express its sincere gratitude to the patients and researchers who participated in the CheckMate -816 clinical trial
.
(This indication has not yet been approved in China
.
The information contained in this material is for reference only, please follow the advice or guidance of your doctor or other healthcare professionals) About CheckMate -816 CheckMate -816 is a randomized, open-label, A multicenter phase III clinical trial to evaluate the efficacy of nivolumab in combination with chemotherapy as neoadjuvant therapy in patients with resectable stage IB to IIIA non-small cell lung cancer compared with chemotherapy alone (according to the 7th edition of AJCC /UICC staging criteria), regardless of tumor PD-L1 expression levels
.
In the primary analysis, 358 patients were randomized preoperatively to receive nivolumab (360 mg) in combination with histologically-typed platinum doublet chemotherapy (every 3 weeks for 3 cycles), or platinum alone Double-drug chemotherapy (3 cycles every 3 weeks) followed by surgery
.
The primary endpoints of the study were event-free survival and pathological complete response rate
.
Secondary endpoints included overall survival, primary pathological response rate, and time to death or distant metastasis
.
About Lung Cancer Lung cancer is the leading cause of cancer death worldwide
.
Non-small cell lung cancer is the most common type of lung cancer, accounting for 84% of all diagnosed cases
.
The majority of NSCLC patients (about 60%) have not yet developed metastases at diagnosis, and up to half of them are resectable
.
This percentage is expected to increase over time as screening increases
.
Although many patients with non-metastatic NSCLC can be cured with surgery, 30% to 55% of patients will relapse and die from the disease after surgery
.
Therefore, multiple treatment options, including preoperative (neoadjuvant therapy) and/or postoperative (adjuvant therapy), are needed to improve long-term survival of patients
.
About Opdivo Opdivo is a PD-1 immune checkpoint inhibitor that uniquely harnesses the body's own immune system to help restore the body's anti-tumor immune response
.
This ability to fight cancer by harnessing the body's own immune system has made Opdivo an important treatment option for polyoma
.
Based on Bristol-Myers Squibb's scientific expertise in the field of immuno-oncology (IO) therapy, Opdivo has a world-leading R&D program covering various phases of clinical trials in multiple tumors, including Phase III clinical trials
.
To date, more than 35,000 patients have been treated with Opdivo in Opdivo's clinical development programs
.
Opdivo's clinical trials contribute to a better understanding of the potential informative role of biomarkers in patient treatment selection, particularly how patients with different PD-L1 expression levels can benefit from Opdivo
.
In July 2014, Opdivo became the first PD-1 immune checkpoint inhibitor in the world to receive regulatory approval, and Opdivo has now been approved in more than 65 countries or regions, including the United States, the European Union, Japan and China
.
Following the first regulatory approval of Opdivo® (nivolumab injection) and Evovo® (ipilimumab injection) for the treatment of metastatic melanoma in October 2015, the current combination therapy The program has been approved in more than 50 countries, including the United States, the European Union and China
.