The American Society of Clinical Oncology (ASCO), founded in 1964, is the largest and most influential professional academic organization in the field of oncology, dedicated to the prevention and treatment of cancer and the improvement of patient care.The 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) will be held from January 18 to 20 local time.
Reply in the background2024ASCO GITo obtain the abstract collection
The Gastrointestinal Cancers Symposium (ASCO-GI) is designed for clinicians, scientists, and all other members of the cancer care and research community, covering a variety of multidisciplinary topics, with expert professors providing insights into advancements in gastrointestinal diseases.The editor has compiled the following heavyweight oral reports and abstract studies from experts at home and abroad, let's take a sneak peek!
Roche's TIGIT Antibody Combination Therapy as First-Line Treatment
Esophageal Squamous Cell CarcinomaPhase III Study Yields Positive Results
Genentech, a subsidiary of Roche, presented Phase III study data (SKYSCRAPER-08) on its TIGIT antibody Tiragolumab in combination therapy for first-line treatment of patients with esophageal squamous cell carcinoma (ESCC) in an abstract at ASCO GI.Tiragolumab is a novel checkpoint inhibitor targeting TIGIT with an intact Fc region. Cancer immunotherapy for ESCC has demonstrated its antitumor activity.
SKYSCRAPER-08 is a Phase III, randomized, double-blind, placebo-controlled study... is evaluating Tiragolumab (anti-TIGIT) + Atezo (anti-PD-L1) in combination with CT versus placebo + CT as a first-line treatment (tx) for unresectable locally advanced (LA), unresectable recurrent or metastatic (R/M) ESCC in the Asian population. The primary endpoints are progression-free survival (PFS) and overall survival (OS) assessed by an independent review facility (IRF).
The study met the two primary endpoints of PFS and OS assessed by IRF.Indicates statistically significant and clinically meaningful improvements in PFS and OS for the tira+atezo+CT group compared to placebo+CT. Consistent overall benefits were observed across subgroups, including PD-L1 status. The safety profile is consistent with the known risks of individual treatments. ClinicalTrials.gov Identifier: NCT04540211.
Eli Lilly: LY3537982 InhibitorUsed for treatment
Phase I Study of KRAS G12C-Mutant Gastrointestinal Cancers
Eli Lilly presented the research results of LOXO-RAS-20001 in the treatment of gastrointestinal tumors at ASCO in abstract form.This is a Phase 1 study of LY3537982 in patients (pts) with KRAS G12C mutations.LY3537982 is an oral, potent, and highly selective GDP-bound KRAS G12C inhibitor developed by Eli Lilly and Company., with unique pharmacological properties, can achieve high target occupancy at a lower absolute exposure. LY3537982 demonstrated treatment outcomes in gastrointestinal tumors in a Phase 1 study among patients (pts) with KRAS G12C mutations.The study adopts a dose escalation following the mTPI-2 method. Dose expansion includes combination therapy with cetuximab for colorectal cancer (CRC). All subjects are naive to KRAS G12C inhibitors, and the primary objectives are to determine the RP2D, safety, PK, and anti-tumor activity according to RECIST v1.1.Results:In patients with gastrointestinal tumors, LY3537982 alone or in combination with cetuximab has shown preliminary efficacy and good safety. ClinicalTrials clinical trial information: NCT04956640.
Shanghai Henlius Biotech, Inc. Two Innovative Products
First Release of Clinical Research Results
On January 17, Shanghai Henlius Biotech, Inc. announced on its official media,Two Innovative Drugs' Latest Clinical Research Results Selected for Presentation at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI).The First Study (HLX10-015-CRC301)A Phase II/III Clinical Study of H Drug Hansizhuang® (Seriulimab) Combined with Hanbeitai® (HLX04, Bevacizumab) and Chemotherapy for First-Line Treatment of Metastatic Colorectal Cancer (mCRC), led by Professor Ruihua Xu from the Sun Yat-sen University Cancer Center as the Principal Investigator.
Serplulimab Combined with HLX04 and XELOX versus Placebo Combined with Bevacizumab and XELOX as First-Line Treatment for Metastatic Colorectal Cancer:A Phase II/III StudyCompared with placebo plus bevacizumab and XELOX, serplulimab combined with HLX04 and XELOX significantly prolonged PFS, improved other efficacy endpoints, and demonstrated manageable safety. Serplulimab combined with HLX04 and XELOX represents a promising first-line treatment option for patients with metastatic CRC, warranting further investigation.The Second Study (HLX22-GC-201)It is a Phase II clinical study on the combination of HLX22, an innovative anti-HER2 monoclonal antibody, with Hanquyou® (Trastuzumab, European trade name: Zercepac®, Australian trade names: Tuzucip® and Trastucip®), and chemotherapy for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer. The principal investigator is Professor Li Jin from Shanghai East Hospital. The details of the data published at this ASCO GI are as follows:HLX22 in Combination with HLX02 and XELOX as First-Line Treatment for HER2-Positive Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer: A Randomized, Double-Blind, Multicenter Phase II Study.Adding HLX22 to HLX02 + XELOX improves survival and antitumor response in first-line treatment of HER2-positive G/GEJ cancer patients, with manageable safety.Adagene's ADG126 Combined with Pembrolizumab
Treatment of MSS CRC Data, Best in Class
On January 17, Adagene's official media announced the data it will present at the ASCO Gastrointestinal (GI) Cancers Symposium. The report title is: Results from a Phase 1b/2 Study of ADG126 (Masked Anti-CTLA-4 SAFEbody® Safety Antibody) in Combination with Pembrolizumab (Pembro) for Patients with Metastatic Microsatellite Stable Colorectal Cancer.
ADG126, generated by Adagene's SAFEbody® technology, targets a unique epitope of CTLA-4 and has demonstrated excellent performance in preclinical studies with the aim of providing enhanced safety. ADG126 is only activated under tumor microenvironment (TME) conditions, enhancing efficacy by effectively depleting regulatory T cells (Treg) while maintaining physiological function through flexible ligand blocking, significantly widening the therapeutic window and offering the potential to address safety issues associated with existing CTLA-4 therapies.This is a Phase 1b/2, open-label, multicenter dose escalation and expansion study of ADG126/Pembro.. The primary endpoints are safety and tolerability. Clinical trial information: NCT05405595. Data as of November 30, 2023:■ The dose-expansion cohort of microsatellite-stable colorectal cancer (MSS CRC) validated a higher-dose, higher-frequency, multiple repeat dosing regimen, with clinical benefit observed and multiple confirmed cases of tumor response using the ADG126 10 mg/kg once every three weeks regimen.■ Preliminary progression-free survival (PFS) analysis of ADG126 at a dose of 10 mg/kg showed a median PFS of up to 7 months in colorectal cancer patients without liver and peritoneal metastases, highlighting its best-in-class potential.■ More patient data under the regimen of 10mg/kg once every 3 weeks is expected to be released gradually in 2024.In the Phase 1b/2 study, ADG126 demonstrated favorable safety and clinical efficacy both as a monotherapy and in combination with anti-PD-1 therapy.The best-in-class performance of ADG126 combined with pembrolizumab in terms of clinical safety and efficacy brings an excellent opportunity for patients with microsatellite-stable colorectal cancer.
ASCO GI is about to begin
ASCO GI is an academic conference in the field of gastrointestinal tumors, which will showcase the most innovative scientific advances in this field and discuss the future treatment directions for gastrointestinal tumors. Due to space limitations, this article does not introduce them one by one.In the next few days, PharmaResearch Network will continue to track this session.ASCO GIConference Progress: Sharing the Latest Advances and Trends in the Field of Digestive System Tumors.
References
1.https://meetings.asco.org2.https://www.clinicaltrials.gov3.https://mp.weixin.qq.com/s/7J7nMjuzM1IHbufMJUckYQ4.https://mp.weixin.qq.com/s/5OO235MFVv0Yp4cywoL2UQ
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