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ASCO GI 2021: Key Studies
An Expert’s Guide to the 2021 Gastrointestinal Cancers Symposium: A Preview of Key Studies

Released: January 14, 2021

Expiration: January 13, 2022

Axel Grothey
Axel Grothey, MD
Manish A. Shah
Manish A. Shah, MD
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During the 2021 ASCO Gastrointestinal (GI) Cancers Symposium virtual meeting, important results from many clinical trials in gastrointestinal malignancies will be reported. Below, experts have highlighted their most anticipated abstracts, which will be covered online as a part of CCO’s Independent Conference Coverage of the 2021 GI Cancers Symposium. After the conference is completed, remember to check the CCO Web site for a downloadable slideset summarizing the key data from the most clinically important studies, as well as a CME-certified online expert analysis featuring discussion and perspectives on the clinical implications of the new data.

Here are the top studies to watch for at the 2021 GI Cancers Symposium, as chosen by experts Axel Grothey, MD, and Manish A. Shah, MD, as well as additional studies that may be of clinically relevant interest.

Colorectal Cancer                                                              
The phase III KEYNOTE-177 study evaluated the antitumor activity of pembrolizumab vs chemotherapy with or without bevacizumab or cetuximab as first-line therapy for patients with microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer (mCRC). In this presentation, Shiu and colleagues report the results of the final analysis of PFS and an analysis of PFS2 (PFS until next line of therapy or any cause death). Results show that first-line treatment with pembrolizumab provided statistically significant PFS improvement vs chemotherapy, as well as clinically meaningful improvement in PFS2, for patients with microsatellite instability–high/mismatch repair–deficient mCRC.

The phase II NRG-GI002 trial is exploring the use of total neoadjuvant therapy in locally advanced rectal cancer. This abstract presents the primary results of the pembrolizumab plus chemoradiotherapy arm, with a primary endpoint of improvement in neoadjuvant rectal cancer score. In another study, Henriksen and colleagues examine the use of postoperative circulating tumor DNA analysis in patients with CRC for assessment of recurrence risk, benefit of adjuvant therapy, and early relapse detection after treatment compared with postoperative carcinoembryonic antigen analysis, reporting that circulating tumor DNA–positive status was significantly associated with reduced relapse-free survival compared with carcinoembryonic antigen.

Final OS results will be presented from the phase II TASCO1 study, evaluating first-line therapy with trifluridine/tipiracil plus bevacizumab or capecitabine plus bevacizumab for patients with unresectable mCRC who are ineligible for intensive therapy. In addition, investigators will report results from the CO.26 trial of durvalumab plus tremelimumab vs best supportive care in microsatellite-stable mCRC, which compared the predictive value of archival tissue tumor mutation burden (TMB) vs plasma TMB biomarkers and found that plasma TMB had better predictive value than tissue TMB for the efficacy of durvalumab plus tremelimumab in patients with microsatellite-stable mCRC.

Gastric/Gastroesophageal Junction Cancers
The phase II FIGHT trial examined the use of the first-in-class FGFR2b-targeting humanized IgG1 monoclonal antibody bemarituzumab combined with modified FOLFOX6 in first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma. Wainberg and colleagues report the regimen’s impact on PFS, OS, and ORR.

Another abstract analyzes the gastric cancer cohort results from the phase II LEAP-005 study of lenvatinib plus pembrolizumab in patients with previously treated select solid tumors. Chung and colleagues report the outcomes of the combination in patients with advanced gastric cancer who had received 2 previous lines of therapy.

In addition, 3 presentations will present new analyses of data from the phase III TAGS study of trifluridine/tipiracil in patients with metastatic gastric or gastroesophageal cancers.

Liver/Hepatobiliary Cancers
Javle and colleagues report final results from a phase II study of the FGFR-targeted TKI infigratinib (BGJ398) in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement. Zhu and colleagues report the final results of the phase III ClarIDHy trial of ivosidenib vs placebo in patients with previously treated cholangiocarcinoma and an IDH1 mutation. In addition, results from the phase II KEYNOTE-224 trial highlight the impact of pembrolizumab monotherapy for patients with previously untreated advanced hepatocellular carcinoma.

Pancreatic Adenocarcinoma
Katz and colleagues present results from the Alliance A021501 trial, examining the use of preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy in patients with borderline resectable adenocarcinoma of the pancreas. Golan and colleagues present final OS results from the phase III POLO trial that examined the use of maintenance therapy with the PARP inhibitor olaparib in patients with metastatic pancreatic cancer and a germline BRCA mutation whose disease did not progress on first-line platinum-based chemotherapy.

Remember to Check the CCO Web Site After the 2021 GI Cancers Symposium!
These are just a few of the interesting and important abstracts selected by our expert faculty from the 2021 GI Cancers Symposium. A downloadable highlight slideset of these studies and more will be available on our Web site after the data are presented. After the meeting, comprehensive analyses by our expert faculty members will explore the clinical implications of the data in a CME-certified text-based module.

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Which of the following clinical trials are you most looking forward to seeing presented at the 2021 GI Cancers Symposium?
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