Gastrointestinal Cancer Treatment Trials Driven by Rising Incidences of Colorectal Cancer

Palm Beach, FL – January 20, 2022 – News Commentary – Despite significant progress in the treatment of gastric cancer, it is still among the leading causes of deaths due to cancer, across the world. The high mortality rates are primarily caused by the late diagnosis of the disease, with patients often missing the opportunity for a surgical cure, and cancer already having been developed into an advanced stage when identified.   Clinical trials are carefully controlled research studies designed to get a closer look at promising new treatments or procedures. Clinical trials in the most part is a definitive way to get state-of-the art cancer treatment. In some cases they may be the only way to get access to newer treatments. Gastric cancer is a common cancer, found, especially in the developing economies of Eastern Asia, Middle and Eastern Europe, and South America. Cases of gastric cancer in China account for 44.2% of the new gastric cancer cases, globally.   According to the estimates of GLOBOCAN 2018, the number of incident cases of stomach cancer in Asia in 2018 was about 769,728 and it is expected to increase to 947,186 by 2025. Although chemotherapy can improve chances of survival for patients with advanced gastric cancer, the overall survival rate is still very low. A significant number of studies have shown that molecular targeted therapy can further improve the survival rates of patients suffering from gastric cancer.   A report from Mordor Intelligence projected that the Gastric Cancer Therapy Market is expected to register a CAGR of 15.8% during the forecast period (2022 – 2027). The report said: “Recently, chemotherapeutic agents, such as pembrolizumab and ramucirumab, have been used for the treatment of gastric cancer. Due to the increasing number of molecular studies of gastric cancers, new molecular targeted drugs have entered into clinical use.”  Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Leap Therapeutics, Inc. (NASDAQ: LPTX), Gamida Cell Ltd. (NASDAQ: GMDA), ALX Oncology Holdings Inc., (NASDAQ: ALXO), Merck (NYSE: MRK).


Mordor Intelligence added: “For example, Trastuzumab, an antibody targeting the human epidermal growth factor receptor 2 (HER2), can significantly improve the survival rates of advanced gastric cancer patients.  Thus, the rising incidences of the stomach cancer is one of the major factors driving the growth of the market. North America is expected to dominate the overall market, throughout the forecast period. In the North American region, the United States holds the largest market share. This is attributed to the rising prevalence of stomach cancer and the availability of advanced technology in cancer research and treatment centers.  Stomach cancer prevalence is expected to increase in the coming years, and the rising number of cancer cases is driving the chemotherapy segment, which is expected to grow further during the forecast period. Chemotherapy-based drugs have been the choice of treatment for decades and have been the among the major treatment options for the treatment of several types of cancers. Hence, the market is expected to witness substantial growth during the forecast period.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Provides Enrollment Update on Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers SymposiumOncolytics Biotech® ) provided an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI).


The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.


“There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast, and hematological cancers. We thus believe pelareorep can increase the proportion of GI cancer patients responding to checkpoint inhibitors and are seeking to validate this hypothesis in the GOBLET study. We are very pleased with the trial’s progress to date and look forward to its continued advancement.”


The GOBLET study builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the study also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.


A copy of the ASCO-GI poster titled, “GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab,” will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.   CONTINUED Read this full press release and more news for ONCY at:    


Other recent developments in the biotech industry of note include:


Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, recently announced the Company will be presenting updated data from the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium being held on January 20-22, 2022.


The Company will host a conference call with Dr. Samuel Klempner of Harvard Medical School and Massachusetts General Hospital on Friday, January 21, 2022 to discuss results from the study.  The latest results from Part A of the DisTinGuish study will be presented, representing first-line advanced G/GEJ patients treated with DKN-01 in combination with tislelizumab and chemotherapy. New data demonstrate compelling efficacy from this combination regimen, driven by enhanced clinical responses and survival benefit associated with high tumoral DKK1 expression that is independent of PD-L1 expression. Also to be presented are initial findings from the still-enrolling Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced G/GEJ patients with high tumoral DKK1 expression, showing the treatment is well tolerated with encouraging objective responses observed.


Gamida Cell Ltd. (NASDAQ: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, recently announced that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.


ALX Oncology Holdings Inc., (NASDAQ: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, recently provided a corporate update and highlighted key milestones anticipated in 2022.


“2021 was a year of substantial corporate and clinical accomplishments for ALX Oncology. We initiated numerous clinical trials, including two Phase 2 trials in head and neck squamous cell carcinoma (“HNSCC”) and presented encouraging Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal junction (“GEJ”) cancer and HNSCC, along with early Phase 1b data from the ASPEN-02 trial in myelodysplastic syndromes (“MDS”),” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.


Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced the final results from the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care (BSC) in patients in Asia with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. KEYNOTE-394 is the first trial with an anti-PD-1/L1 as a second-line monotherapy treatment to show an improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo plus BSC for these patients. These data add to the body of evidence relating to the use of KEYTRUDA as a monotherapy in second-line HCC post sorafenib.


KEYTRUDA plus BSC demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of OS, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]; p=0.0180) compared to placebo plus BSC for patients with previously treated advanced HCC. For patients treated with KEYTRUDA plus BSC, median OS was 14.6 months (95% CI, 12.6-18.0) compared to 13.0 months (95% CI, 10.5-15.1) for patients treated with placebo plus BSC. The percentage of patients who were alive at two years was 34.3% for KEYTRUDA plus BSC compared to 24.9% for placebo plus BSC. These data will be presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium (Abstract #352788) on Friday, Jan. 21 at 10:15 a.m. ET.


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