An Expert’s Guide to ASCO GI 2023: A Preview of the Top Abstracts

During the 2023 ASCO Gastrointestinal Cancers Symposium, important results from many clinical trials across gastrointestinal (GI) malignancies will be reported. GI cancer experts Christopher H. Lieu, MD, and Rachna Shroff, MD, MS, have highlighted their most anticipated abstracts, which we will cover online as part of CCO’s Independent Conference Coverage of ASCO GI 2023. Remember to check the CCO website often as the meeting unfolds for downloadable slidesets summarizing the data from these studies and then again for a CME-certified online text module featuring expert analyses and perspectives on the clinical implications of the new data.

The experts identified the following key studies of interest to be reported at ASCO GI 2023.

• SPOTLIGHT: Primary results will be presented from this phase III study of first-line zolbetuximab (a Claudin 18.2‒targeted antibody) plus mFOLFOX6 vs placebo plus mFOLFOX6 for patients with Claudin 18.2‒positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Per a November press release, this study met its primary endpoint of progression-free survival. This study is likely practice changing, and the assessment of Claudin 18.2 for newly diagnosed patients with gastric or GEJ adenocarcinoma now will become a best practice.
• NAPOLI-3: The first data will be presented from this randomized phase III study of liposomal irinotecan plus 5-fluorouracil/leucovorin plus oxaliplatin (NALIRIFOX) vs nab-paclitaxel plus gemcitabine for treatment-naive patients with metastatic pancreatic ductal adenocarcinoma. A November press release indicated that this study met its primary overall survival (OS) endpoint. This study could make NALIRIFOX the treatment of choice for newly diagnosed patients with metastatic pancreatic adenocarcinoma.
• SUNLIGHT: Earlier studies have suggested a benefit to adding bevacizumab to TAS-102 (trifluridine/tipiracil) for patients with previously treated metastatic colorectal cancer (mCRC). SUNLIGHT is a randomized phase III study of TAS-102 with or without bevacizumab for third-line treatment of refractory mCRC. Per a press release, this study met its primary OS endpoint and likely will support the addition of bevacizumab to TAS‑102 for patients with refractory mCRC, thus changing existing practice.
• SWOG 1815: Cisplatin plus gemcitabine has been a first-line standard of care for advanced biliary tract cancers. SWOG 1815 is a randomized phase III trial assessing the potential for adding nab-paclitaxel to this combination in this patient population.

Additional studies to watch in gastroesophageal and biliary tract cancers include:

• CheckMate 648: 29-month follow-up data from the phase III trial of first-line nivolumab plus chemotherapy or ipilimumab vs chemotherapy for patients with advanced esophageal squamous cell carcinoma.
• CheckMate 649: 3-year follow-up data from the phase III trial of first-line nivolumab plus chemotherapy vs chemotherapy for patients with advanced gastric cancer/GEJ cancer/esophageal adenocarcinoma.
• HERIZON: OS data from a phase II trial of HER-Vaxx (or IMU-131, a HER2-targeting peptide vaccine) in combination with standard of care chemotherapy for patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma.
• LEAP-015: Data will be presented from the safety run-in part of this randomized, 2-part phase III study of first-line lenvatinib plus pembrolizumab plus chemotherapy vs chemotherapy for patients with HER2-negative locally advanced unresectable or metastatic gastroesophageal adenocarcinoma.
• IMbrave151: This randomized phase II trial assessed the addition of atezolizumab with or without bevacizumab to cisplatin plus gemcitabine for patients with untreated, advanced biliary tract cancer.

Additional studies of interest in colorectal cancers include:

• A single-arm phase II trial of pemigatinib (an FGFR inhibitor) in patients with mCRC with FGF/FGFR alterations.
• MOUNTAINEER analysis: A concordance analysis comparing breast and gastric HER2 testing algorithms in the mCRC setting based on samples from MOUNTAINEER, a phase II study of tucatinib plus trastuzumab for patients with HER2-positive mCRC.
• MOUNTAINEER-03: A first look at an ongoing phase III study of first-line tucatinib plus trastuzumab plus mFOLFOX6 for patients with HER2-positive mCRC. 
• NRG-GI002: Long-term follow-up data from the randomized phase II trial platform assessing the addition of veliparib or pembrolizumab to total neoadjuvant therapy for patients with locally advanced rectal cancer.
• OPERA: Final surgical salvage results from a randomized phase III trial assessing the impact of a contact x-ray brachytherapy boost vs an external beam radiation therapy boost on rectal preservation rate for patients with early rectal cancer receiving chemoradiotherapy.

Your Thoughts?
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