BEIJING and SHANGHAI and CHICAGO, June 1, 2024
/PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology
company focusing on undruggable targets, presented updated data of
a KRAS G12C inhibitor glecirasib (JAB-21822) in combination with a
SHP2 inhibitor (JAB-3312) in
frontline non-small cell lung cancer (NSCLC) patients harboring
KRAS G12C mutation at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting as form of oral presentation.
Jacobio also presented updated data of pivotal phase II study of
glecirasib as form of oral presentation at an education
session.
As of April 7, 2024, 194 patients
participated in a phase II trial of using glecirasib combined with
JAB-3312 (NCT05288205), of which 102 patients were frontline NSCLC.
The median follow-up time was 10.1 months.
In the oral abstract session (Abstract No. 3008), Professor
Jun Zhao, chief physician of Beijing
Cancer Hospital, the principal investigator of glecirasib combined
with JAB-3312 study, presented the clinical data. About 102
frontline NSCLC patients have been enrolled in 7 dose groups. The
confirmed objective response rate (cORR) was 64.7% (66/102), the
disease control rate (DCR) was 93.1% (95/102), and the median
progression-free survival (mPFS) was 12.2 months, respectively.
This trial explored a total of 7 different dose cohorts, and the
optimal dose group was glecirasib at 800mg daily combined with
JAB-3312 at 2mg daily one week on and one week off. The cORR of the
optimal dose group was 77.4% (18/31), and 54.8% (17/31) of patients
achieved a deep response with tumors shrinking by more than 50%.
The mPFS was not yet mature.
Regarding on the safety data, among the 194 patients, the
incidence of grade 3 or 4 treatment-related adverse events (TRAE)
was 43.8%, and there was no treatment-related death. Common TRAEs
treatment-related adverse events include anemia,
hypertriglyceridemia, etc. The safety profile in the frontline
NSCLC is similar to that of the overall study population, and the
overall safety is manageable.
Professor Jie Wang, chief
physician of Beijing Cancer Hospital, commented, "from the above
data, it can be seen that the combination therapy of glecirasib and
JAB-3312 has a good safety profile, and the efficacy data shows
positive therapeutic potential. If the combination of the two oral
drugs can show superiority to the existing standard therapy
(immunotherapy combined with chemotherapy) in subsequent trials, we
anticipate that patients can avoid the side effects of chemotherapy
or immunotherapy."
The combination therapy of glecirasib and JAB-3312 is being
tested in a Phase III clinical trial of frontline NSCLC with KRAS
G12C mutation in China.
Andrea Gillam-Wang M.D., Ph.D.,
Chief Medical Officer and Global Head of R&D of Jacobio, said:
"Our R&D efforts have been focusing on patient needs. We look
forward to testing this novel combination against standard care
chemotherapy and immunotherapy in NSCLC, and potentially replace
standard care regimen consisted of multiple intravenous agents with
two oral agents."
The new drug application (NDA) of glecirasib monotherapy for the
second-line NSCLC with KRAS G12C mutation was granted Priority
Review designation by China CDE on May 21,
2024 In the education session of ASCO, Professor
Yuankai Shi, chief physician of
Cancer Hospital Chinese Academy of Medical Sciences, updated the
data of the Phase II registration trial of NSCLC with KRAS G12C
mutation in an oral report.
Jacobio Pharma will hold a data discussion call at 20:00
Beijing time on June 3. Please click the link to register:
https://s.comein.cn/A9SRr.
About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number
of Phase I/II clinical trials of glecirasib are currently ongoing
in China, the United States and Europe for patients with advanced solid tumors
harboring KRAS G12C mutation. These include combination therapy
trials with SHP2 inhibitor JAB-3312
in NSCLC and with cetuximab in colorectal cancer. The pancreatic
cancer indication has obtained orphan drug designation in
the United States and breakthrough
therapy designation in China.
About JAB-3312
JAB-3312 is a highly selective SHP2
allosteric inhibitor with best-in-class potential. Jacobio is
currently conducting clinical trials of JAB-3312 in monotherapy and
combination therapies with glecirasib and other agents in
China, the United States and Europe. The phase III study in combination
with KRAS G12C inhibitor Glecirasib has been approved by China CDE
in Feb 2024.
About Jacobio
Jacobio Pharma (1167.HK) is committed to developing and providing
new and innovative products and solutions. Our pipeline revolves
around novel molecular targets on six major signalling pathways:
KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim
for our key projects to be among the top three in the world. Our
vision is to become a global leader recognized for our impact in
drug R&D together with our partners. Jacobio has R&D
centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug
Discovery Platform (IADDP) and our iADC Platform.
Please visit www.jacobiopharma.com for more
information
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SOURCE Jacobio Pharma