New data from landmark analysis presented today report a
decreased risk of disease recurrence or death in patients with
resectable NSCLC who received adjuvant nivolumab following
neoadjuvant nivolumab plus chemotherapy and surgery compared to
those who received only neoadjuvant nivolumab plus
chemotherapy.
SAN
DIEGO, Sept. 8, 2024 /PRNewswire-PRWeb/ --
Perioperative Nivolumab May Provide Meaningful Improvement in
Event-Free Survival Compared to Only Neoadjuvant Nivolumab Plus
Chemotherapy for Resectable NSCLC
"The individual patient-level data analysis
from CheckMate 77T and CheckMate 816 indicates that perioperative
nivolumab offers a notable improvement in EFS over neoadjuvant
nivolumab plus chemotherapy alone in patients with resectable
NSCLC." -- Dr. Patrick Forde
San Diego, Calif--September 8, 2024, 10:05
a.m. PCT – New data from landmark analysis presented today
report a decreased risk of disease recurrence or death in patients
with resectable NSCLC who received adjuvant nivolumab following
neoadjuvant nivolumab plus chemotherapy and surgery compared to
those who received only neoadjuvant nivolumab plus
chemotherapy.
The data was reported at the International Association for the
Study of Lung Cancer 2024 World Conference on Lung Cancer.
This is the first analysis of individual patient-level data from
two phase 3 trials, CheckMate 77T and CheckMate 816, to examine
which patients may derive benefit from adjuvant nivolumab following
neoadjuvant nivolumab plus chemotherapy and surgery for stage I-III
NSCLC.
CheckMate 816, which was led by Dr. Patrick Forde of The Bloomberg-Kimmel Institute
for Cancer Immunotherapy, The Sidney Kimmel Comprehensive Cancer,
in Baltimore, MD., evaluated
neoadjuvant nivolumab plus chemotherapy. The study demonstrated
statistically significant and clinically meaningful improvements in
event-free survival and pathological complete response and is the
sole approved, neoadjuvant only immunotherapy-based treatment for
resectable NSCLC.
Building on this foundation, Dr. Tina
Cascone of the MD Anderson Cancer Center, in Houston, and her collaborators developed
CheckMate 77T, which assessed perioperative nivolumab, revealing
statistically significant and clinically meaningful improvement in
event-free survival and a meaningful increase in pathological
complete response rate compared to control.
This analysis compared event-free survival from the time of
surgery among patients from CheckMate 77T, who received neoadjuvant
nivolumab plus chemotherapy followed by definitive surgery and at
least one dose of adjuvant nivolumab, with patients from CheckMate
816, who also received neoadjuvant nivolumab plus chemotherapy
followed by definitive surgery but without adjuvant nivolumab.
After applying propensity score weights to account for
differences in baseline characteristics, perioperative nivolumab
(N=139) showed improved event-free survival compared to neoadjuvant
nivolumab plus chemotherapy only (N=147). Specifically, the hazard
ratios for EFS were 0.61 (weighted ATE) and 0.56 (weighted ATT). Of
note, EFS benefit was observed regardless of pCR status although
the benefit was clearer in patients without pCR who received
additional adjuvant nivolumab treatment after surgery. Benefit was
seen regardless of baseline disease stage, with a greater magnitude
of benefit in patients with tumor PD-L1 of less than 1 percent. No
new safety signals were seen with perioperative nivolumab.
"The individual patient-level data analysis from CheckMate 77T
and CheckMate 816 indicates that perioperative nivolumab offers a
notable improvement in EFS over neoadjuvant nivolumab plus
chemotherapy alone in patients with resectable NSCLC, including
those with PD-L1 of less than one percent expression," reported Dr.
Forde. "While the findings should be considered with caution due to
the limitations of propensity score weighting, this cross-trial
analysis provides compelling evidence supporting perioperative
nivolumab as an effective treatment option for resectable NSCLC."
Dr. Cascone added.
"This is the first individual patient-level analysis
demonstrating improved efficacy of perioperative nivolumab compared
with the standard of care neoadjuvant only nivolumab plus
chemotherapy in resectable NSCLC," she added. "These results should
be interpreted with caution given the exploratory nature of the
analysis. Nevertheless, the findings are very encouraging and
provide a foundation for thoughtful discussions with our patients
regarding treatment options for their disease."
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC)
is the only global organization dedicated solely to the study of
lung cancer and other thoracic malignancies. Founded in 1974, the
association's membership includes more than 10,000 lung cancer
specialists across all disciplines in over 100 countries, forming a
global network working together to conquer lung and thoracic
cancers worldwide. The association also publishes the Journal of
Thoracic Oncology, the primary educational and informational
publication for topics relevant to the prevention, detection,
diagnosis, and treatment of all thoracic malignancies.
About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world's largest
meeting dedicated to lung cancer and other thoracic malignancies,
attracting nearly 7,000 researchers, physicians and specialists
from more than 100 countries. The goal is to increase awareness,
collaboration and understanding of lung cancer, and to help
participants implement the latest developments across the globe.
The conference will cover a wide range of disciplines and unveil
several research studies and clinical trial results.
Media Contact
Chris Martin, IASLC, 6306702745,
cmartin@davidjamesgroup.com, www.iaslc.org
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