ASCO 2018: Genosco/Yuhan Announce Results from Phase 1/2 Study of Lazertinib (YH25448, GNS-1480), a 3rd-Generation EGFR-TKI, ...
03 Juni 2018 - 3:00PM
Business Wire
Genosco, a clinical-stage biotechnology company focused in
immunology and oncology, announced data from a Phase 1/2 study
evaluating lazertinib (YH25448, GNS-1480) in patients with advanced
Non-Small Cell Lung Cancer (NSCLC) at the 2018 American
Society of Clinical Oncology (ASCO) Annual Meeting. Lazertinib
(YH25448, GNS-1480), Genosco’s 3rd-generation EGFR-tyrosine kinase
inhibitor (EGFR-TKI) candidate partnered for clinical development
and commercialization with Yuhan Corporation, is an oral, potent,
irreversible EGFR-TKI that is highly selective for activating
(EGFRm) and T790M resistance mutations.
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ASCO Abstract 9033 Infographic (Graphic:
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Results from the open-label, multi-center dose-escalation, Phase
1/2 study of lazertinib (YH25448, GNS-1480) for patients with
advanced EGFR-TKI-resistant NSCLC with or without CNS metastasis
concluded that lazertinib was well-tolerated with low rates of
Grade 3 or higher adverse events (AE) and exhibited robust activity
in patients with NSCLC with acquired resistance to EGFR-TKIs, with
or without brain metastasis. Principal Investigator Byoung Chul
Cho, M.D., Ph.D., Division of Medical Oncology, Department of
Internal Medicine, Yonsei Cancer Center, Yonsei University College
of Medicine, Seoul, Republic of Korea presented the data in a
poster session (Abstract 9033).
“These data are impressive and underscore the potential of
lazertinib (YH25448, GNS-1480) to be the best-in-class
3rd-generation EGFR-TKI for patients with advanced EGFR T790M
mutant NSCLC, including brain metastasis. And importantly, the
treatment was well-tolerated with no dose-limiting toxic effects,”
said Dr. Byoung Chul Cho. “Results indicate that lazertinib
compares favorably with results from a similar Phase 1/2 clinical
trial of osimertinib (AURA)1, a currently marketed 3rd generation
EGFR-TKI.”
“The efficacy signals and safety profiles are highly encouraging
and validate lazertinib (YH25448, GNS-1480) as a promising
3rd-generation EGFR-TKI inhibitor for patients with limited
options,” said Jong Sung (John) Koh, Ph.D., Genosco CEO. “Yuhan and
Genosco initiated a global Phase 2 trial evaluating lazertinib for
patients with NSCLC and anticipate a global Phase 3 trial in
2019.”
“These results confirm our belief that recently presented
pre-clinical data at AACR2 may translate into human studies,” said
Ho-Juhn Song, Ph.D., Director of Biology and Strategic Alliance of
Genosco. “The comparative analyses of lazertinib and osimertinib
concluded that lazertinib showed greater potency and selectivity,
excellent intracranial penetration, superior in vivo efficacy in
both single (del19, L858R) and double (L858R/T790M) mutant
xenograft models and superior in vivo efficacy in a brain
metastasis model.”
Study results:
A total of 118 patients [dose-escalation cohort (n=38) and
expansion cohort (n=80)] with EGFRm advanced NSCLC with acquired
resistance to EGFR-TKIs with or without brain metastasis were
enrolled in the Phase 1/2 study as of April 20, 2018.
The results demonstrate that lazertinib (YH25448, GNS-1480) has
a good safety profile and was generally well-tolerated. No
dose-limiting toxicities were observed up to lazertinib 320mg and
there were no dose-dependent increases in treatment-emergent
adverse events (TEAEs). Of the evaluable patients (n=110) with a
confirmed response at the date of data cutoff, lazertinib (YH25448,
GNS-1480) demonstrated promising anti-tumor efficacy signals with a
confirmed objective response rate (ORR) of 61% across all dose
levels. Of note, the confirmed ORR in patients with T790M+ was 86%
at the lazertinib 240mg dose level and in patients with brain
metastasis, the intracranial ORR was 55% across all dose
levels.
Key findings include:
Anti-tumor efficacy – all confirmed responses Overall
Objective Response Rate (ORR) – all doses (n=110) 61%
ORR - T790M-positive patients – all doses (n=92) 66%
ORR - T790M-positive patients – 240 mg dose (n=7) 86%
ORR - T790M-negative patients – all doses (n=18) 33%
ORR – patients with brain metastasis (n=11) 55%
Tolerability (Adverse Event) Any AEs of grade 3-5 11%
Any drug-related AEs grade 3-5 2%
EDITORS NOTE: An infographic accompanying this release is
available.
Sources:1 N Engl J Med 372;18 nejm.org April 30, 2015; AZD9291
in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer.2 AACR 2018
Annual Meeting Abstract Number 4790: YH25448, an irreversible
3rd-generation EGFR TKI, exhibits superior anticancer effects with
potent brain BBB penetration in NSCLC.
About Lazertinib
Lazertinib (YH25448, GNS-1480) is an oral, potent, highly
mutant-selective and irreversible, investigational 3rd-generation
EGFR-TKI that penetrates the blood-brain barrier (BBB). It targets
the activating EGFR mutations Del19 and L858R, as well as the T790M
mutation, while sparing wild type. EGFR mutations are present in
approximately 10-15% of NSCLCs. Lazertinib is being evaluated in
advanced NSCLC as both first- and second-line treatments.
About Genosco
Located in Cambridge, MA, Genosco is a clinical-stage
biotechnology company led by CEO, Dr. Jong Sung (John) Koh,
focusing on developing and commercializing novel immunology and
oncology treatments to improve the lives of patients. Genosco’s
core competence comes from its expertise in generating selective
kinase inhibitors that include candidates that target EGFRm+
(NSCLC), SYK (Autoimmune diseases) and FLT3/AXL (AML) and other
conditions. The company is enrolling patients in a Phase 1 study of
SKI-G-801 for AML and expects to initiate a Phase 2 study of
SKI-O-703 in ITP and RA in 2018. In 2015, Genosco partnered
globally with Yuhan Corporation for development and
commercialization of lazertinib (YH25448, GNS-1480), a
3rd-generation EGFR-TKI, for treatment of NSCLC currently in Phase
2 clinical trials. Genosco was founded in 2008 as a subsidiary
company of Oscotec, Inc, (KOSDAQ: 039200), South Korea. For more
information, please visit www.genosco.com.
About Yuhan Corporation
Yuhan Corporation is a globally operating, leading
pharmaceutical company in South Korea led by CEO Jung Hee Lee.
Founded in 1926 by Dr. Ilhan New, the company is engaged in
research and development (R&D), drug manufacturing, CMO
business, marketing and distribution of a broad spectrum of
pharmaceutical and healthcare products. R&D strategies of Yuhan
Corporation revolve around, first and the foremost, the patient
needs. This patient-centered approach has directed the focus of
Yuhan R&D on two critical areas of unmet medical needs;
oncology and metabolic diseases. For more information, please visit
www.yuhan.co.kr.
Source: Genosco
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