On August 11, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported the initiation of a Phase 2 investigator-sponsored study of evorpacept, a next generation CD47 blocker, in combination with ERBITUX (cetuximab) and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with refractory microsatellite stable metastatic colorectal cancer ("mCRC") who have progressed on at least two lines of systemic therapy (Press release, ALX Oncology, AUG 11, 2022, View Source [SID1234618146]).
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This is an open-label, multi-center, single-arm phase 2 clinical trial (NCT05167409). Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, will respectively provide ERBITUX and KEYTRUDA to support this study. This trial is being co-led by Wells Messersmith, M.D., Professor and Head of Medical Oncology at the University of Colorado Cancer Center and Director of the Academic GI Cancer Consortium ("AGICC"), and Robert Lentz, M.D., Assistant Professor of Medical Oncology at the University of Colorado Cancer Center. AGICC brings together a world class team of institutions and investigators to design and rapidly complete clinical trials in gastrointestinal cancers. The study is being managed by Criterium, Inc., a full-service contract research organization dedicated to providing efficiency and expertise in clinical trial services.
"In conjunction with AGICC, we are excited to initiate this study that builds upon the promising clinical activity and tolerability observed in patients with advanced solid tumors observed in ASPEN-01, ALX Oncology’s phase 1b study," said Dr. Messersmith. "mCRC is a difficult-to-treat cancer and patients, particularly in the relapsed/refractory setting, will benefit from novel therapeutic options to help improve disease outcomes. From a mechanistic perspective, the combination of a CD47 blocker with cetuximab and pembrolizumab acts through different but complementary mechanisms, and we aim to see evorpacept in this triplet combination positively impact efficacy without increasing toxicity."
ALX Oncology owns worldwide commercial rights to evorpacept.
About Colorectal Cancer
Colorectal cancer ("CRC") starts in the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start. Most CRCs start as polyps on the inner lining of the colon or rectum and grow into the wall of the colon or rectum over time. According to the National Cancer Institute, CRC is the fourth most common cancer diagnosed in the United States. In 2019, there were an estimated 1,369,000 Americans living with the disease, and people with metastatic CRC have a 5-year survival rate of just 15.1%.