Oncology Experts Preview Top Abstracts to be Shared at 2025 ASCO GI

Tanios S. Bekaii-Saab, MD, and Yelena Y. Janjigian, MD, preview top presentations from this year’s Gastrointestinal Cancers Symposium.

Ahead of this year’s Gastrointestinal Cancers Symposium, OncLive® asked Ad Board members and experts in the space, Tanios S. Bekaii-Saab, MD, and Yelena Y. Janjigian, MD, about which presentations they are most excited to learn more about and why.

Bekaii-Saab is the David F. and Margaret T. Grohne Professor of Novel Therapeutics for Cancer Research, and chair and consultant of the Division of Hematology and Medical Oncology at Mayo Clinic in Arizona. Janjigian is chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center (MSKCC) in New York, NY. Jeremy Tchack, MD, a hematology/medical oncology fellow (PGY-4) at MSKCC, assisted with the compilation.

This abstract made the list for both doctors:

LBA143: First results of nivolumab (NIVO) plus ipilimumab (IPI) vs NIVO monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) from CheckMate 8HW

Bekaai-Saab: “The first results from this study show a significant improvement in progression-free survival [PFS] for nivolumab [Opdivo] plus ipilimumab [Yervoy] over chemotherapy. It is unclear whether the results that will be discussed at ASCO GI will include a comparison of ipilimumab/nivolumab vs nivolumab [for] all lines or first line only. If ipilimumab/nivolumab shows improved outcomes vs nivolumab alone in the frontline [setting], then this is transformational in the sense that ipilimumab/nivolumab will become the preferred first-line [regimen] for microsatellite instability­–high [MSI-H] mCRC.”

Janjigian: “Andre et al have already demonstrated that ipilimumab/nivolumab is demonstrably more effective than chemotherapy for patients with metastatic MSI-H/dMMR colon cancer—a finding we all expected. This week’s presentation on the ipilimumab/nivolumab vs nivolumab analysis of CheckMate 8HW will reveal the results of the first direct head-to-head comparison of dual vs single agent checkpoint blockade in mismatch repair–deficient disease. The finding of a significant incremental benefit of dual checkpoint blockade would certainly be practice changing.”

The rest of Dr Bekaii-Saab’s list:

16: BREAKWATER: Analysis of first-line encorafenib + cetuximab + chemotherapy in BRAF V600E-mutant metastatic colorectal cancer

“The results of this study will transform practice by establishing doublet chemotherapy [CT] plus encorafenib [Braftovi] and cetuximab [Erbitux; EC] as the standard of care for patients with metastatic colorectal cancer [mCRC] and a BRAF V600E mutation. In fact, the FDA just granted accelerated [approval] to EC + CT based on an improvement in the confirmed objective response rate [ORR] by approximately 20% vs CT.”

LBA22: A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease (MRD) following curative resection of colorectal cancer (CRC): The ALTAIR study

“This trial is one of the first phase 3 prospective randomized trials to test the utility of minimal residual disease [MRD] assessment with therapeutic intervention and its predictive value on outcome, [in this case,] disease-free survival. If positive, this study will further consolidate the value of MRD and expand its utility in early-stage CRC.”

520: Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) therapy for unresectable hepatocellular carcinoma (uHCC): CheckMate 9DW expanded analyses

“The landscape of treatment options in unresectable hepatocellular carcinoma has become very complex with 2 established options (atezolizumab [Tecentriq]/bevacizumab [Avastin] and tremelimumab [Imjudo]/durvalumab [Imfinzi]). The combination of nivolumab/ipilimumab showed significant promise vs lenvatinib [Lenvima] or sorafenib [Nexavar] with concerns regarding more toxicities vs historical expectations, primarily given the higher ipilimumab dose. The expanded analyses may provide further insight re: updated efficacy and safety measures. In the absence of head-to-head comparisons vs other immune-oncology–based combinations, it will be difficult to consider this as a preferred standard but only an additional option for patients with a great level of performance.”

519: Adjuvant chemotherapy or chemo-radiation in gallbladder cancer (GBC): A phase III randomized controlled study (ACCELERATE trial)

“The role of adjuvant chemotherapy with capecitabine is considered standard for patients with resected gallbladder cancer. Phase 2 studies have shown contradictory [results] regarding the benefit from more intense chemotherapy and/or a role of chemoradiation. The results of this phase 3 study will help further understand the benefits of adjuvant chemotherapy +/- radiation post resection for gallbladder cancer.”

The rest of Dr Janjigian’s list:

332: Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC)

“Promising topline data released last summer points to a significant improvement in ORR and PFS with synergy of co-targeting the checkpoint CD47 and HER2. These results will give us a more complete look at whether targeting CD47 with evorpacept adds benefit in conjunction with standard therapy in the second line for patients with HER2-positive advanced disease. I am particularly interested to see how patients previously treated with fam-trastuzumab deruxtecan-nxki [Enhertu; T-DXd] or checkpoint inhibitors [ICIs] fared—interim data seemed to suggest benefit. As T-DXd–based combinations and ICI move to the front line, a meaningful benefit in this subgroup could certainly impact practice.”

327: Intraperitoneal and intravenous paclitaxel plus S-1 versus intravenous paclitaxel plus S-1 in gastric cancer patients with peritoneal metastasis: Results from the multicenter, randomized, phase 3 DRAGON-01 trial

“Several studies [PHOENIX-GC, GASTRIC, PERMIT trials] have examined intraperitoneal [IP] chemotherapy in metastatic gastric cancer involving the peritoneum; despite showing some improvement in PFS, these studies failed to show improvements in overall survival [OS]. The DRAGON-01 trial reexamines the PHOENIX-GC approach with IP and intravenous paclitaxel with S-1 in the neoadjuvant setting as a conversion mechanism to downstage the peritoneum and enable radical gastrectomy in a Chinese population. This is an ambitious study whose primary end point of OS recognizes the morbidity of peritoneal disease—I’m looking forward to seeing whether this could impact care in a high-risk population.”

15: Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort

20: Tumour-free ctDNA detection as a decision tool to support organ preservation in node-negative rectal cancer undergoing neoadjuvant chemotherapy, excision, and observation in the phase II NEO trial (CCTG CO.28)

“One focus of this year’s Symposium will be to further clarify actionable roles for circulating tumor DNA [ctDNA] in clinical decision making. Last year, we learned, unsurprisingly, that ctDNA can guide decisions of adjuvant chemotherapy by identifying patients at high risk of recurrence, based on the interim analysis of the BESPOKE CRC trial [NCT04264702; final analysis to be presented this week re: abstract 15]. The direct testing of ctDNA to support decisions for organ sparing in node-negative rectal cancer [NEO trial; NCT03259035; abstract 20] is a sensible and practical use case for ctDNA to optimize selection of patients who may be safely managed with an organ-sparing approach.”

23: Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM)

“We know ICI has had mixed, if disappointing, results so far in metastatic microsatellite stable [MSS] CRC, although last year’s phase 1 study of botensilimab/balstilimab showed a modest response rate with durable responses in a small subset. Unfortunately, in that study, sharp differences were observed in response rates between patients with active liver metastases [ORR, 0%] and those with no/treated liver disease [ORR, 22%]. Although the field will have to overcome this apparent immunotherapy resistance of liver metastases in non-liver, MSS gastrointestinal primary cancers, I hope this larger cohort that excludes patients with active liver metastases redemonstrates the response rate observed in the phase 1 trial. If so, this could add treatment options for this subset of patients and would represent an important milestone in treatment of advanced MSS disease.”

Check back for the rest of our coverage from the 2025 Gastrointestinal Cancers Symposium.