USA News Group Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, June 19, 2024 /PRNewswire/ — USA News Group – This year’s 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) has now come and gone, but not without increasing hope for cancer patients around the world. This year’s ASCO 2024 theme was ‘The Art and Science of Cancer Care: From comfort to cure,’ with attendees hearing presentations from experts and receiving a wide range of important clinical results for the first time. According to analysts at Spherical Insights, the Global Oncology Drugs Market is projected to be worth $564.5 billion by 2033, growing at a CAGR of 11.5%. Because a new drug typically might take 10-15 years to complete all 3 phases of clinical trials, the developments of today directly impact the results of tomorrow. This is why retail investors are wise to pay attention to the milestones and data shared by this year’s ASCO attendees, which included Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie Inc. (NYSE: ABBV), AstraZeneca PLC (NASDAQ: AZN), Pfizer Inc. (NYSE: PFE), and Bristol-Myers Squibb Company (NYSE: BMY).
Updating the audience for its flagship novel immunotherapy, pelareorep, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts demonstrating further potential for the intravenously delivered immunotherapeutic agent in pancreatic cancer and its immunotherapeutic mechanism of action across multiple cancer indications.
Oncolytics’ first abstract presented was for a trial-in-progress of cohort 5 of the company’s GOBLET study, evaluating the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without Roche’s atezolizumab (Tecentriq®) in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
“The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company’s pancreatic cancer program,” said Dr. Matt Coffey, President and CEO of Oncolytics. “The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy.”
Funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN), Oncolytics Biotech plans to start enrolling patients this quarter following regulatory clearance received in May.
The GOBLET cohort 5 abstract and poster detail a study assessing innovative treatments for patients newly diagnosed with metastatic PDAC. Utilizing a Simon two-stage design, the study aims to determine if the treatments are promising enough for further investigation. Initially, 15 patients per treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab.
The study’s primary goals include evaluating the effectiveness and safety of these treatments. Researchers will measure progression-free survival (the length of time patients live without the cancer worsening), overall survival (the total length of time patients live), and biomarkers (biological indicators of treatment response). Should the first stage yield positive results, one or both treatment groups may progress to the second stage, which will involve an additional 17 patients per arm.
Throughout the study, blood and tumor samples will be collected for in-depth analysis. This approach aims to provide a comprehensive understanding of how the treatments impact patient outcomes and pave the way for potential future advancements in PDAC therapy.
Among the big pharma contenders that presented at ASCO 2024 was AbbVie Inc. (NYSE: ABBV), which took the opportunity at the meeting to showcase its robust solid tumor pipeline, with new data from its innovative antibody-drug conjugate (ADC) platform. AbbVie’s ADCs are designed to target unique protein biomarkers such as c-Met (MET protein) and SEZ6 (seizure-related homolog 6 protein), which are over-expressed across various tumor types. The biotech giant states that by utilizing these biomarkers as targets, ADCs are designed to deliver potent cancer cell death-inducing agents called ‘payloads’ to the tumor.
“Building upon our strong commitment to patients and existing leadership in hematological malignancies, we are rapidly advancing a differentiated pipeline in solid tumors,” said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors, Oncology Development, for AbbVie. “Our ADC platform allows us to utilize selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death by delivering potent anti-cancer agents.”
At the meeting, Abbvie presented positive Phase I and II trial data for three ADC therapies, Teliso-V, ABBV-400 and ABBV-706, in solid tumour patients—with Teliso-V being the company’s most advanced c-Met targeted ADC in development.
The LUMINOSITY study enrolled 172 patients with c-Met protein overexpression and epidermal growth factor receptor wild type, advanced/metastatic non-squamous NSCLC. The Teliso-V results showed a mean overall response rate (ORR) of 28.6%, with ORRs of 34.6% in c-Met high patients and 22.9% in c-Met intermediate patients. The therapy demonstrated a median duration of response (DOR) of 9 months in c-Met high patients and 7.2 months in c-Met intermediate patients.
Another ADC gaining attention was Enhertu, developed by British multinational AstraZeneca PLC (NASDAQ: AZN) and Japanese multinational Daiichi Sankyo. In a clinical trial, Enhertu reduced the risk of breast cancer progression by 37% compared to chemotherapy in patients who are HER2-positive, HER2-low, and HER2-ultralow.
“DESTINY-Breast06 represents another potential paradigm shift in how we treat patients across the spectrum of HR-positive metastatic breast cancer,” said Susan Galbraith, Executive Vice President, Oncology R&D, of AstraZeneca. “The results reinforce the potential for Enhertu to improve outcomes earlier in the treatment landscape and in a broader population of patients with HER2-expressing breast cancer who have never before been eligible for a HER2-directed therapy.”
AstraZeneca achieved multiple successes at ASCO this year. Among the highlights was the impressive performance of Tagrisso in a phase 3 lung cancer trial. The kinase inhibitor significantly reduced the risk of disease progression by 84% compared to the placebo.
“Tagrisso extended progression-free survival by more than three years in this potentially curative setting, reinforcing the need to test and diagnose patients early,” said Galbraith. “These practice-changing data cement the powerful impact Tagrisso can make as backbone therapy in EGFR-mutated lung cancer, especially in the lives of these patients who have historically experienced early progression following chemoradiotherapy.”
Another highlight at ASCO 2024 came from Pfizer Inc.’s (NYSE: PFE) phase 3 clinical trial results for Lorbrena, a drug approved by the U.S. Food and Drug Administration (FDA) for non-small cell lung cancer (NSCLC) in 2021. The five-year follow-up of patients with the ALK mutation showed that Lorbrena reduced the risk of disease progression by 81% compared to Xalkori, a recognized first-line treatment for NSCLC.
Lorbrena’s readout was among the most impressive at ASCO as 60% of the patients showed a five-year progression-free survival.
“These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “These results are an excellent example of Pfizer’s long-standing commitment to discovering and developing scientific breakthroughs for patients, and support LORBRENA as a standard of care for the first-line treatment of people with ALK-positive advanced NSCLC.”
Another class of drugs that garnered attention at ASCO 2024 was KRAS inhibitors. However, the trial results from Bristol-Myers Squibb Company (BMS) (NYSE: BMY) and Amgen each experienced challenges. Although KRAS mutations are common in non-small cell lung cancer (NSCLC), and despite the drug being granted accelerated approval by the FDA in 2022, BMS’s Krazati underperformed when looking at median progression-free survival, even though it reduced tumor progression risk by 42%.
Krazati’s median progression-free survival (PFS) – the period during which a patient’s condition remains stable after treatment – extended beyond chemotherapy by 1.7 months in a confirmatory study.
“The accelerated approval of KRAZATI from the FDA in 2022 was welcome news for patients with KRASG12C-mutated locally advanced or metastatic NSCLC,” said Abderrahim Oukessou, M.D., Vice President, Global Program Lead, KRAZATI, Bristol Myers Squibb. “These confirmatory results further support KRAZATI as an efficacious, targeted treatment option for these patients. We look forward to further sharing these results, while also continuing to evaluate KRAZATI in other advanced KRASG12C-mutated solid tumors.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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