Eric Van Cutsem, MD, PhD, professor of medicine, division head, Department of Digestive Oncology, University of Leuven (KUL), University Hospitals Gasthuisberg, Leuven Belgium, discusses primary efficacy and safety findings from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials investigating the monoclonal antibody zolbetuximab (IMAB362) in metastatic gastric cancer.

The international, randomized, placebo-controlled SPOTLIGHT trial compared the use of zolbetuximab plus mFOLFOX6 vs mFOLXOX6 and placebo in patients with Claudin 18.2 (CLDN18.2)–positive, HER2-negative, locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, Van Cutsem begins. A significant proportion of patients with advanced gastric cancer are CLDN18.2-positive, he notes.

Primary results from the study presented at the 2023 ASCO Gastrointestinal Cancers Symposium showed that zolbetuximab plus mFOLXOX6 elicited statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS), Van Cutsem states.

Positive topline results from the GLOW trial of zolbetuximab in combination with capecitabine and oxaliplatin (CAPOX) were also recently reported, Van Cutsem adds. This trial evaluated this regimen vs CAPOX plus placebo as first-line treatment in the same population as SPOTLIGHT, and zolbetuximab plus data demonstrated a statistically significant PFS and OS for patients treated with zolbetuximab plus CAPOX.

These randomized studies support use of zolbetuximab in combination with current chemotherapy regimens as a novel and effective treatment strategy for CLDN18.2-positive advanced gastric cancer, Van Cutsem states.

Additionally, HER2, microsatellite instability status and PD-1 biomarker testing is now standard in the frontline setting for advanced gastric cancer. If zolbetuximab receives approval in this setting, CLDN18.2 should be assessed as an additional prognostic marker in this disease space, Van Cutsem concludes.

Videos

Eric Van Cutsem, MD, PhD, discusses primary efficacy and safety findings from the phase 3 SPOTLIGHT and GLOW trials investigating the monoclonal antibody zolbetuximab in metastatic gastric cancer.

Dr. Van Cutsem on Primary Findings from the SPOTLIGHT and GLOW Trials in Metastatic Gastric Cancer

Eric Van Cutsem, MD, PhD, of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses regorafenib (Stivarga) as a treatment for patients with colorectal cancer (CRC).

Eric Van Cutsem, MD, PhD, of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses regorafenib (Stivarga) as a treatment for patients with colorectal cancer.

Dr. Van Cutsem on Regorafenib for Patients With Colorectal Cancer

Eric Van Cutsem, MD, PhD, of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses the safety profile of the phase III B CONSIGN study, which looked at regorafenib in patients with previously treated metastatic colorectal cancer (mCRC).

There were minimal toxicities in the study, and all were consistent with what was found in the CORRECT study, which also investigated regorafenib in mCRC, said Van Cutsem. There were no new safety concerns found, although 40-50% of patients did require some dose modification. Common toxicities included hypertension, fatigue, and hand-foot-skin reaction. 

Progression-free survival was also similar to the CORRECT study, which validated regorafenib's efficacy in a larger population, said Van Cutsem.

View more from the 2015 World GI Congress

Eric Van Cutsem, MD, PhD, of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses the safety profile of the phase III B CONSIGN study, which looked at regorafenib in patients with previously treated metastatic colorectal cancer (mCRC).


Dr. Eric Van Cutsem on Regorafenib for Metastatic Colorectal Cancer

Eric Van Cutsem, MD, PhD, of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses the use of trastuzumab for the treatment of advanced HER2-positive gastric cancer.

Trastuzumab is utilized as a targeted therapy for both gastric cancer and breast cancer, but gastric cancer has its own unique set of challenges, says Van Cutsem.

While toxicity is not as much of an issue with trastuzumab for gastric cancer as it is for breast cancer, survival is shorter. Resistance is also a challenge, says Van Cutsem, and efforts need to be made to better understand the mechanisms behind it.   

View more from the 2015 GI Cancer Symposium

Eric Van Cutsem, MD, PhD of University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, discusses the use of trastuzumab for the treatment of advanced HER2-positive gastric cancer.

Eric Van Cutsem, MD, PhD

Articles

Dr. Van Cutsem on Primary Findings from the SPOTLIGHT and GLOW Trials in Metastatic Gastric Cancer

Dr. Van Cutsem on Regorafenib for Patients With Colorectal Cancer

Dr. Eric Van Cutsem on Regorafenib for Metastatic Colorectal Cancer

Dr. Cutsem on Challenges of Targeted Therapies in Gastric Cancer