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ASCO 2024 Preview: Groundbreaking Advances in Gastrointestinal (GI) Cancer!

Gastrointestinal (GI) Cancer Preview | ASCO 2024

The ASCO 2024 conference will spotlight groundbreaking advancements in gastrointestinal cancer, focusing on colorectal cancer, hepatocellular carcinoma, pancreatic cancer, and gastric/gastroesophageal cancer. Leading pharmaceutical companies, including Innovent Biologics, Cue Biopharma, Merck, BeiGene, Astellas Pharma, Eucure Biopharma, Bold Therapeutics, Bristol-Myers Squibb, Ipsen, and others, are set to present their latest research and developments, anticipated to spark significant interest and discussion.

Colorectal cancer is more prevalent in males (~50%) compared to females (~40%) in the United States. This year’s ASCO meeting is highly anticipated for the release of data on innovative molecules such as IBI363, M9140, and ABBV-400. ASCO 2024 will introduce new therapeutic classes such as PD-1/IL-2 bispecific antibodies, EP4 antagonists, PD-1 inhibitors, and ERK 1/2 inhibitors. The treatment landscape for colorectal cancer has been notably transformed by Vorbipiprant, an EP4 receptor antagonist, and ERAS-007, a potential best-in-class ERK1/2 inhibitor. Cue Biopharma will also unveil Phase I data on WT1-pHLA-IL2-Fc fusion protein, which could pave the way for new treatment options.

Hepatocellular carcinoma (HCC), which makes up about 85%-90% of all primary liver cancer cases, will also be a major focus. A highlight will be the final overall survival analysis of the Phase III CARES-310 study by Jiangsu HengRui Medicine, offering crucial insights into improving survival outcomes for HCC patients and potentially shifting the treatment landscape positively.

In pancreatic ductal adenocarcinoma (PDAC), one of the most immune-resistant tumor types, the conference will spotlight top-class innovations including CLDN18.2/CD3, DNA topoisomerase I inhibitors, and RAF/MEK and FAK inhibitors. CLDN18.2 is overexpressed in solid tumors like gastric cancer and PDAC, both of which are characterized by immunosuppressive cells such as regulatory T cells (Tregs) and limited effector T cells (Teffs). In February 2024, the US FDA approved ONIVYDE (irinotecan liposome) for the first-line treatment of metastatic pancreatic adenocarcinoma. ASCO 2024 will feature updates on the overall survival analysis of the NAPOLI 3 trial for irinotecan liposome, offering valuable insights into its efficacy.

For gastroesophageal junction adenocarcinoma, a rare cancer of the esophagus, key highlights will include anti-claudin 18.2, anti-claudin 18.3, and PD-1 inhibitors. Bold Therapeutics' BOLD-100, with its unique multimodal mechanism of action, is also gaining therapeutic recognition.

Catch a glimpse of the compiled list of worthwhile GI abstracts and posters:

Gastrointestinal Cancer Key Abstracts

Company

Drug

Trial ID/ Acronym

Phase

Abstract ID

Abstract Title

Colorectal Cancer

IBI363

NCT05460767

Ia/Ib

Poster Session - 256, Abstract- 3593

First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced colorectal cancer: Safety and efficacy results from a Phase I study.

CUE-102

NCT05360680

I

Poster Session - 216, Abstract- 3553

A Phase I, open-label, dose escalation, and expansion study of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein, in patients with HLA-A*0201-positive disease and WT1-positive recurrent/metastatic cancers.

Vorbipiprant

NCT05205330

I/II

Poster Session - 223, Abstract- 3560

Updated results and subgroup analysis by presence of liver metastases of a phase I/II study of the EP4 antagonist vorbipiprant with the anti-PD-1 balstilimab in mismatch-repair-proficient and microsatellite stable (pMMR/MSS) chemorefractory metastatic colorectal cancer (mCRC)

Tislelizumab

NCT05116085

II

Poster Session - 262, Abstract- 3599

Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: An open-label, single-arm, multicenter phase II study

M9140

NCT05464030

I


Oral Abstract Session - 3000

First-in-human trial of M9140, an anti-CEACAM5 antibody-drug conjugate (ADC) with exatecan payload, in patients (pts) with metastatic colorectal cancer (mCRC).


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ABBV-400

NCT05029882

I

Rapid Oral Abstract Session - 3515

First-in-human study of ABBV-400, a novel c-Met–targeting antibody-drug conjugate, in advanced solid tumors: Results in colorectal cancer.

ERAS-007

NCT05039177

(HERKULES-3)

I/II

Rapid Oral Abstract Session - 3517

Updated results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with EC-naïve metastatic BRAF V600E colorectal cancer (CRC) in the Phase Ib/II HERKULES-3 study

Hepatocellular Carcinoma

Nivolumab + ipilimumab

NCT04039607

(CheckMate-9DW)

III


Oral Abstract Session - LBA4008

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW.

SCT-I10A

NCT04560894

II/III

Poster Session - 72, Abstract- 4092

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial.

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VG161

NCT04806464

I

Poster Session - 85, Abstract- 4105

Clinical outcomes from a Phase I clinical trial of a novel oncolytic virus VG161 in patients with hepatocellular carcinoma (HCC) refractory after 2 prior lines of therapy including checkpoint inhibitors (CPI).

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BOLD-100 + FOLFOX chemotherapy

NCT04421820

Ib/IIa

Poster Session - 85, Abstract- 4105

A Phase II study of BOLD-100 in combination with FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer: Efficacy and safety analysis (BOLD-100-001).

Pancreatic Cancer

IBI389

NCT05164458

I

Clinical Science Symposium - 4011

Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a Phase I study.

MK-0482 + pembrolizumab + gemcitabine + nab-paclitaxel

NCT03918278

I

Poster Session - 119, Abstract- 4139

Phase I study of anti–immunoglobulin-like transcript 3 (ILT3) monoclonal antibody MK-0482 + pembrolizumab + gemcitabine + nab-paclitaxel (Gem/Nab-P) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC)

Avutometinib

NCT05669482

I/II

Poster Session - 120, Abstract- 4140

Avutometinib/defactinib and gemcitabine/nab-paclitaxel combination in first-line metastatic pancreatic ductal adenocarcinoma: Initial safety and efficacy of phase Ib/II study (RAMP 205).

Mitazalimab

NCT04888312

(OPTIMIZE-1)

Ib/II

Poster Session - 113, Abstract- 4133

OPTIMIZE-1 primary analysis: Safety, efficacy, and biomarker results of a Phase Ib/II study combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Irinotecan

NCT04083235

(NAPOLI 3)

III

Poster Session - 116, Abstract- 4136

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3

MK-0482

NCT03918278

(MK-0482-001)

I

Poster Session - 119, Abstract- 4139

Phase I study of anti–immunoglobulin-like transcript 3 (ILT3) monoclonal antibody MK-0482 + pembrolizumab + gemcitabine + nab-paclitaxel (Gem/Nab-P) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC)

M108

NCT04894825

Ib

Poster Session - 122, Abstract- 4142

FG-M108 plus nab-paclitaxel and gemcitabine (AG) as first-line (1L) treatment for patients with Claudin-18.2 (CLDN18.2) positive locally advanced unresectable or metastatic pancreatic cancer (PC): Preliminary results from the phase 1b study

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YH003 + toripalimab

NCT05031494

II

Poster Session - 126, Abstract- 4146

A Phase II, multicenter, open-label study to evaluate the safety and efficacy of YH003 in combination with toripalimab (anti-PD-1 mAb) in patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC)

fuzuloparib + mFOLFIRINOX

NCT04425876

I

Poster Session - 143, Abstract- 4163

Perioperative fuzuloparib plus mFOLFIRINOX for resectable pancreatic adenocarcinoma: A Phase I study

BXCL701

NCT05558982

(EXPEL PANC)

II

Poster Session - 112, Abstract- LBA4132

Phase II trial of BXCL701 and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma (EXPEL-PANC): Preliminary findings

Gastric/ Gastroesophageal Cancer

Enfortumab vedotin

NCT04225117

II

Poster Session - 26, Abstract- 4046

Enfortumab vedotin (EV) in previously treated gastric/esophageal cancers cohorts of EV-202.

Osemitamab (TST001)

NCT04495296

I/II

Poster Session - 28, Abstract- 4048

First-line osemitamab (TST001) plus nivolumab and capox for advanced g/GEJ cancer (TranStar102): Results of cohort G from a phase I/IIa study.

Zolbetuximab + mFOLFOX6

NCT03504397

(SPOTLIGHT)

III

Poster Session - 16, Abstract- 4036

Final overall survival results from Phase III SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

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Minnelide

NCT05566834

I

Poster Session - 13, Abstract- 4033

A Phase I study to evaluate the safety and preliminary efficacy of minnelide given alone or in combination with paclitaxel in advanced gastric cancer.

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BOLD-100 + FOLFOX chemotherapy

NCT04421820

I/II

Poster Session - 39, Abstract- 4059

A Phase II study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastric cancer: Efficacy and safety analysis (BOLD-100-001).

Cadonilimab + pulocimab + paclitaxel

NCT04982276

I/II

Rapid Oral Abstract Session - 4012

Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial.

 

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Executive Summary

The ASCO 2024 conference will spotlight groundbreaking advancements in gastrointestinal cancer, focusing on colorectal cancer, hepatocellular carcinoma, pancreatic cancer, and gastric/gastroesophageal cancer.

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