Reference Detail

Ref Type

abstract

PMID

Authors

Atsushi Horiike; Hiroshi Wakui; Shunichi Sugawara; Yuji Minegishi; Sadatomo Tasaka; Sojiro Kusumoto; Toshio Sakatani; Hiroyuki Suzuki; Yukio Hosomi; Yuichi Tambo; Tsuneo Shimokawa; Hiroo Ishida; Eisaku Miyauchi; Katsuhiko Naoki; Tatsuro Fukuhara; Emiko Mura; Toshiaki Tsurui; Risako Suzuki; Nana Iriguchi; Tomoyuki Ishiguro; Yuya Hirasawa; Ryo Manabe; Masahiro Shimokawa; Ryotaro Ohkuma; Hirotsugu Ariizumi; Yutaro Kubota; Kazuyuki Hamada; Sachiko Takenoshita; Kakei Ryu; Takehiko Sambe; Eisuke Inoue; Satoshi Wada; Kiyoshi Yoshimura; Hironori Sagara; Shinichi Kobayashi; Takuya Tsunoda

Title

Abstract CT032: Promotive clinical effects of pembrolizumab with necitumumab in patients having advanced non-small cell lung cancer with PD-L1 expression of 50% or higher in a phase II study (K-TAIL-202)

Journal	Vol	Issue	Date	Pages	Journal Short Title
Cancer Research	84	7_Supplement	April 1, 2024

URL

https://aacrjournals.org/cancerres/article/84/7_Supplement/CT032/742504/Abstract-CT032-Promotive-clinical-effects-of

Abstract Text

Background: Pembrolizumab is the standard of care for advanced non-small cell lung cancer (NSCLC) with high programmed death-1 ligand 1 (PD-L1) expression. However, combination therapies comprising pembrolizumab and ipilimumab, tiragolumab, or lenvatinib have not demonstrated superior efficacy in this patient group. This study explored the effectiveness of the novel combination of pembrolizumab and necitumumab as first-line therapy in patients having advanced NSCLC with PD-L1 expression of 50% or higher. Methods: Patients with untreated advanced NSCLC with PD-L1 expression of 50% or higher received pembrolizumab and necitumumab every 3 weeks up to 35 cycles. The primary endpoint was investigator-assessed objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events. The sample size was calculated using 80% power with a one-sided alpha error of 10%, a threshold ORR of 39.0%, and an expected ORR of 54.8%. Results: From December 2020 to March 2023, 50 patients were enrolled. Patient characteristics were as follows: male/female patients: 38/12; median age: 72 years (range: 51-90 years); histology, adenocarcinoma/squamous cell carcinoma/other: 35/15/5; and PS, 0/1: 20/30. At the time of the primary analysis, the ORR was 76.0% (95% CI: 61.9%-86.9%), with 2.0%, 74.0%, 10.0%, and 8.0% of the patients showing complete response, partial response, stable disease, and progressive disease, respectively. The median PFS was 15.7 months (95% CI, 10.3 to not reached) and the median OS was not reached. Common toxicities included rash (86%) and hypomagnesemia (60%). Grade 3 interstitial lung disease was noted in 5 patients (10%) and grade 5 cardiac arrest in 1 patient (2%). Conclusion: Combination therapy comprising pembrolizumab and necitumumab demonstrated a 76.0% ORR, meeting the primary endpoint, with manageable toxicities. The regimen showed promising clinical activity in patients with NSCLC and high PD-L1 expression, warranting further investigation. Clinical trial ID: jRCT2031200248.

Filtering

Case insensitive filtering will display rows if any text in any cell matches the filter term
Use simple literal full or partial string matches
Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
Click on any column header arrows to sort by that column
Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 over exp	lung non-small cell carcinoma	predicted - sensitive	Necitumumab + Pembrolizumab	Phase II	Actionable	In a Phase II trial, first-line treatment with Keytruda (pembrolizumab) plus Portrazza (necitumumab) resulted in an objective response rate of 76.0%, median progression-free survival of 15.7 months, and median overall survival that was not reached in patients with advanced non-small cell lung cancer with high CD274 (PD-L1) expression (>=50%) (n=50) (Cancer Res (2024) 84 (7_Supplement): CT032).	detail...