Phase 2 results from the NeoCOAST-2 study demonstrated that the
combination of durvalumab with Dato-DXd yielded the highest
pathological complete response rates among the tested regimens.
SAN
DIEGO, Sept. 8, 2024 /PRNewswire-PRWeb/
-- NeoCOAST-2 Data Shows Combination of Durvalumab with novel
agents increases pathological responses in resectable NSCLC -- Data
Builds on AEGEAN Study Research
"The NeoCOAST-2 study is the first global
Phase 2 platform trial to provide evidence that the combination of
durvalumab with novel agents, particularly Dato-DXd, yields the
highest rates of pathological complete response among the tested
regimens." -- Dr. Tina
Cascone.
Phase 2 results from the NeoCOAST-2 study demonstrated that the
combination of durvalumab with Dato-DXd yielded the highest
pathological complete response rates among the tested regimens.
The data was presented at the International Association for the
Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer
by Dr. Tina Cascone, from The
University of Texas MD Anderson Cancer
Center in Houston.
"The findings highlight the potential of combining durvalumab
with novel anticancer agents to build on what we have learned in
the perioperative immunotherapy arena for patients with
early-stage, resectable NSCLC to enhance treatment outcomes and
safety profiles," Dr. Cascone reported.
The NeoCOAST-2 study is an open-label, multicenter Phase 2 trial
that builds on the results of the NeoCOAST and AEGEAN studies as
foundation for evaluating the efficacy of durvalumab combined with
chemotherapy and novel agents as neoadjuvant therapy, followed by
adjuvant therapy with durvalumab alone or with additional agents.
The study aimed to improve pathological complete response (pCR)
rates in patients with resectable NSCLC.
The study enrolled patients with untreated, histologically
confirmed Stage IIA-IIIB NSCLC, stratified by PD-L1 expression, and
randomized them into several arms, including the three reported
arms:
- Arm 1: Neoadjuvant durvalumab and platinum-doublet CT with
oleclumab
- Arm 2: Neoadjuvant durvalumab and platinum-doublet CT with
monalizumab
- Arm 4 Neoadjuvant durvalumab and single-agent platinum CT
with Dato-DXd (TROP2-directed antibody-drug conjugate).
Patients received neoadjuvant therapy every three weeks for four
cycles prior to surgery, followed by adjuvant treatment with the
respective regimens until disease progression or up to one year.
Primary endpoints included pCR rate, safety, and tolerability,
while secondary endpoints covered event-free survival, feasibility
of surgery, major pathological response (mPR) rate, and objective
response rate.
Dr. Cascone and her colleagues randomized 202 patients (Arm 1:
n=76; Arm 2: n=72; Arm 4: n=54). Of those, 92.2%, 92.1%, and 95.8%
of patients in Arms 1, 2, and 4, respectively, underwent surgery.
The pCR rates were 20%, 26.7%, and 34.1% for Arms 1, 2, and 4,
respectively, with corresponding mPR rates of 45%, 53.3%, and
65.9%. Arm 4 showed the highest pCR rate and a generally favorable
safety profile. Treatment-related adverse events (TRAEs) occurred
in 94.6% of patients in Arm 1, 90.1% in Arm 2, and 96.3% in Arm 4,
with grade ≥3 TRAEs reported at 31.1%, 29.6%, and 18.5%,
respectively.
"The NeoCOAST-2 study is the first global Phase 2 platform trial
to provide evidence that the combination of durvalumab with novel
agents, particularly Dato-DXd, yields the highest rates of
pathological complete response among the tested regimens," said Dr.
Cascone.
"This promising efficacy, coupled with a manageable safety
profile, underscores the potential of these novel treatment
combinations in improving outcomes for patients with resectable
NSCLC, and the results affirm the viability of integrating novel
anticancer agents into neoadjuvant and perioperative therapy for
enhanced clinical benefit."
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. Visit
http://www.iaslc.org for more information.
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. For more
information, visit https://wclc2024.iaslc.org.
Media Contact
Chris Martin, IASLC, 6306702745,
cmartin@davidjamesgroup.com, www.iaslc.org
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SOURCE IASLC