Cancer Immunotherapy Surge Drives $258B Market as FDA Accelerates Approvals
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Sept. 16, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's accelerated approval of two oncology treatments in August 2025[1] signaled the recent wave of regulatory momentum behind next-generation therapies. Meanwhile, advanced treatment platforms are achieving complete tumor elimination in clinical trials across multiple cancer types[2]. These developments position Oncolytics Biotech Inc. (NASDAQ:ONCY), Anixa Biosciences, Inc. (NASDAQ:ANIX), IceCure Medical Ltd. (NASDAQ:ICCM), ImmunityBio, Inc. (NASDAQ:IBRX), and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN).
Industry analysts at Exactitude Consultancy project the cancer immunotherapy market will reach $258.22 billion by 2031[3], driven by breakthrough treatment platforms and precision technologies that are transforming how tumors are detected and destroyed. The convergence of FDA fast-track approvals, revolutionary immune-based treatments, and innovative therapeutic approaches creates optimal conditions for companies positioned at the forefront of next-generation cancer care.
Oncolytics Biotech Inc. (NASDAQ:ONCY) just marked a key milestone with the expansion of its GOBLET study into U.S. clinical sites, setting the stage for faster enrollment and upcoming data readouts across multiple gastrointestinal cancers. The company's immunotherapy, pelareorep, is now planned to open at Northwestern University and other academic institutions, bringing this breakthrough treatment to American patients with pancreatic cancer and other hard-to-treat tumors.
"We expect to build on this clinical momentum to lay the foundation for our regulatory strategy," said Jared Kelly, CEO of Oncolytics. "It's imperative that we leverage our clinical data to obtain regulatory clarity and position pelareorep as a platform immunotherapy in these gastrointestinal tumors where patients desperately need treatment options."
The timing is significant, with multiple cohorts from GOBLET already showing strong efficacy signals, including a 33% overall response rate in second-line squamous cell carcinoma of the anal canal patients. This nearly triples the response rate achieved by existing treatments in this rare but deadly cancer. With 20 evaluable patients enrolled and completion expected by the end of 2025, an efficacy update is anticipated in Q4 2025.
The most closely watched program is Cohort 5, which evaluates pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This randomized cohort tests pelareorep with modified FOLFIRINOX chemotherapy with or without a checkpoint inhibitors, building on earlier data where pelareorep combinations achieved a stunning 62% objective response rate in 13 evaluable patients. Enrollment is 40% complete, with full enrollment expected by the end of 2026, and interim overall survival data anticipated in Q1 2026.
The expansion strategy validates pelareorep's potential as a platform immunotherapy. This systemically delivered oncolytic virus transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Unlike traditional chemotherapy that attacks cells indiscriminately, pelareorep selectively replicates within cancer cells while simultaneously activating the body's natural immune defenses.
Previous colorectal cancer studies reinforced pelareorep's potential, showing survival nearly tripled compared to standard of care and extended disease control in KRAS-mutant patients.
Pancreatic cancer data has been equally compelling. Patients achieved a two-year survival rate of 21.9 percent, more than double the historical benchmark of 9.2% with standard chemotherapy. Crucially, pelareorep combinations showed objective responses in a majority of patients (62%), suggesting it may unlock checkpoint inhibitor effectiveness in tumors long considered resistant to immunotherapy.
The company is in active discussions with the FDA to finalize pivotal study parameters, aiming to begin trial activities by Q4 2025. This signals a move from proof-of-concept toward regulatory-stage development.
Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones.
With U.S. site expansion accelerating enrollment, multiple efficacy readouts scheduled through 2026, and ongoing FDA discussions for registration-enabling trials, Oncolytics appears positioned at a critical inflection point. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes.
With additional catalysts lined up through 2026, an experienced leadership team, and survival outcomes far ahead of standard care, pelareorep may be approaching the point where clinical promise becomes commercial reality.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Anixa Biosciences, Inc. (NASDAQ:ANIX) has completed dosing of the fourth cohort in its Phase 1 ovarian cancer CAR-T clinical trial, with patients receiving 3×10⁶ CAR-positive cells per kilogram, marking a 30-fold increase versus the first cohort. Multiple treated patients remain alive beyond disease-specific median survival benchmarks, with one patient from the first cohort alive 28 months post-treatment. The Moffitt Cancer Center partnership continues to observe a positive safety profile with no dose-limiting toxicities, cytokine release syndrome, or immune effector cell-associated neurotoxicity reported.
"With the completion of the fourth cohort, we are gaining important insights into the potential of our CAR-T therapy for ovarian cancer at higher dose levels," said Dr. Amit Kumar, CEO of Anixa Biosciences. "While this study is primarily designed to assess safety, we are encouraged by the early indications of potential efficacy, and look forward to initiating the next dose cohort following the standard safety review."
The fifth cohort is expected to commence following routine safety verification, planned at approximately 1×10⁷ cells/kg. Anixa's FSHR-targeting CAR-T technology, exclusively licensed from The Wistar Institute, represents a differentiated approach using natural FSH ligand binding rather than antibody fragments for tumor targeting.
IceCure Medical Ltd. (NASDAQ:ICCM) has received regulatory approval from Israel's Ministry of Health for its next-generation XSense™ cryoablation system across multiple oncology indications, including breast cancer treatment. The approval encompasses general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology applications. XSense™ had previously received FDA clearance in mid-2024 for all indications approved for the company's flagship ProSense® system.
"We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation," said Eyal Shamir, CEO of IceCure Medical. "The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."
The XSense™ platform technology provides minimally invasive tumor destruction by freezing, targeting benign and cancerous lesions in breast, kidney, lung, and liver applications. IceCure's liquid-nitrogen-based systems offer a transportable design enabling office-based procedures for breast tumors with reduced surgical risks and complications.
ImmunityBio, Inc. (NASDAQ:IBRX) has demonstrated that ANKTIVA® reverses lymphopenia and extends overall survival in patients with advanced non-small cell lung cancer resistant to checkpoint therapy. In the Phase 2 QUILT-3.055 study, 80% of patients exceeded an absolute lymphocyte count above 1,000 cells/µL, with patients achieving counts greater than 1,500 cells/µL demonstrating statistically significant prolonged median overall survival of 21.1 months. This represents a paradigm shift from the historical 7-9 months survival with docetaxel in advanced lung cancer patients.
"These results present the clinical evidence that a low lymphocyte count, as measured by ALC levels, is an actionable, accessible biomarker to identify and treat therapy-induced lymphopenia in cancer patients with ANKTIVA and prolong overall survival," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "ANKTIVA is the first FDA-approved immunotherapy to stimulate natural killer cells, CD4+ CD8+ T cells and memory T cells, the very cells that are depleted resulting in lymphopenia, and that play a key role in the immune system's fight against cancer."
The randomized Phase 3 ResQ201A trial is currently enrolling patients to evaluate ANKTIVA plus tislelizumab versus docetaxel alone in second-line NSCLC patients. ANKTIVA represents the first FDA-approved lymphocyte-stimulating agent specifically targeting therapy-induced lymphopenia as the foundation of ImmunityBio's BioShield™ platform.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) has released five-year follow-up results from the Phase 3 EMPOWER-Lung 3 trial showing Libtayo® plus chemotherapy achieved a more than double five-year overall survival rate of 19.4% compared to 8.8% with chemotherapy alone. The combination demonstrated 21.1-month median overall survival versus 12.9 months, representing a 34% reduction in risk of death with consistent efficacy across tumor histologies. Squamous NSCLC patients showed particularly notable benefit with 22.3-month median overall survival.
"After more than five years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival – with an impressive overall survival probability of 19.4% at five years – when Libtayo is added to chemotherapy in patients with advanced non-small cell lung cancer," said Dr. Ana Baramidze, Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia. "Long-term results across tumor histologies were also reported, including a notable 22.3-month median overall survival for squamous NSCLC patients."
The safety profile at five years remained consistent with previously reported data, with the median duration of exposure 39 weeks to Libtayo plus chemotherapy versus 21 weeks to chemotherapy alone. Regeneron's oncology assets comprise nearly half of the company's development programs, with Libtayo serving as the backbone for multiple investigational combination therapies across more than 30 cancer types.
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SOURCES CITED:
- https://www.onclive.com/view/onclive-s-august-roundup-of-key-fda-approvals-in-oncology-3-decisions-to-know
- https://www.rockefeller.edu/news/38120-immunotherapy-drug-eliminates-aggressive-cancers-in-clinical-trial/
- https://www.globenewswire.com/news-release/2024/12/16/2997514/0/en/Cancer-Immunotherapy-Market-Insights-Growth-Opportunities-In-Personalized-Medicine-Exactitude-Consultancy.html
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