GI Cancer Immunotherapy Breakthroughs Signal New Treatment Era
VANCOUVER, British Columbia, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – The FDA approved the first perioperative immunotherapy for early gastric and gastroesophageal junction cancers last month, ushering in a new clinical paradigm for patients with historically resistant tumors [1]. Separately, the agency fast-tracked an experimental pancreatic cancer therapy based on early trial results showing tumors shrinking in nearly a third of patients[2]. These regulatory milestones position immunotherapy platforms capable of unlocking durable responses across multiple gastrointestinal malignancies as the next wave of commercial opportunity, drawing attention to developers advancing combination regimens in colorectal, pancreatic, and anal cancers. Among companies positioned to capitalize on this shift are Oncolytics Biotech Inc. (NASDAQ:ONCY), Agenus Inc. (NASDAQ:AGEN), Cardiff Oncology, Inc. (NASDAQ:CRDF), Exelixis, Inc. (NASDAQ:EXEL), and Gilead Sciences, Inc. (NASDAQ:GILD).
Analysts project the global immuno-oncology market will climb at a CAGR of 15.7% toward a value of US$416.28 billion by 2034[3].
Oncolytics Biotech Inc. (NASDAQ:ONCY) has secured FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease.
Following a Type C meeting, the FDA and Oncolytics agreed on key trial parameters, establishing a clear path toward potential approval in a cancer with no existing immunotherapy treatments.
"We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape," said Jared Kelly, CEO of Oncolytics Biotech. "The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options."
The trial will test three arms: standard chemotherapy (gemcitabine plus nab-paclitaxel) alone, the same chemotherapy with pelareorep, and chemotherapy with both pelareorep and a checkpoint inhibitor. Overall survival serves as the primary goal, with either experimental arm able to independently demonstrate success.
"The FDA's feedback confirms that our design is appropriate to support registration if successful," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We are now completing the administrative activities necessary to initiate the program, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete."
The protocol allows checkpoint inhibitor flexibility based on ongoing partnership discussions. Pelareorep has successfully combined with multiple checkpoint inhibitors across gastrointestinal and other cancers.
Oncolytics recently reported anal cancer data showing response rates more than double the current standard, reinforcing pelareorep's platform potential across gastrointestinal tumors. Previous pancreatic cancer data demonstrated a 62% response rate and two-year survival rates more than double the historical benchmark.
The company recently established a Gastrointestinal Scientific Advisory Board to advance pelareorep beyond pancreatic cancer alone.
Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, enabling expedited review and potential market exclusivity.
CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets through value-creating transactions.
With site selection underway and protocol finalization in progress, Oncolytics stands positioned at the transition from clinical promise to regulatory reality as the only immunotherapy registration trial in first-line pancreatic cancer.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
Agenus (NASDAQ:AGEN) achieved a significant regulatory milestone as France's medicines agency ANSM authorized reimbursed compassionate access for botensilimab plus balstilimab in refractory MSS metastatic colorectal cancer without active liver metastases, marking the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by any regulatory agency. The company presented compelling two-year survival data at ESMO and ESMO-GI spanning more than 400 patients across five refractory cancers, with 123 heavily pretreated MSS mCRC patients achieving 42% two-year overall survival and 20.9-month median OS compared to benchmark median OS of 8-14 months with current standards of care.
The global Phase 3 BATTMAN trial is launching in the fourth quarter of 2025 across more than 100 sites in Canada, France, Australia, and New Zealand in collaboration with the Canadian Cancer Trials Group and supported by AGITG and PRODIGE, evaluating BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer. Agenus reported approximately $100.9 million gain from MiNK deconsolidation in the third quarter after ownership fell below 50%, resulting in net income for both the three-month and nine-month period ended September 30, 2025, while the company expects patients to commence treatment in both government-reimbursed pathways in France and self-pay programs in several European countries and other regions.
Cardiff Oncology (NASDAQ:CRDF) announced highly encouraging data from its ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated metastatic colorectal cancer, with the 30mg onvansertib cohort demonstrating a 19% improvement in confirmed objective response rate, faster time to response, deeper tumor regression, and early signs of separation in progression-free survival curves compared to standard of care alone at the July 8, 2025 data cutoff. The PLK1 inhibitor continues to demonstrate a favorable tolerability profile with no major or unexpected toxicities observed, while dose-dependent responses were observed across all endpoints, including ORR, PFS, early tumor shrinkage, and depth of response.
"This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. "Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients."
The company expects to report an update from the ongoing Phase 2 CRDF-004 trial in the first quarter of 2026, focusing on continuation of onvansertib's favorable tolerability profile and more mature duration of response and progression-free survival data. With cash, cash equivalents, and short-term investments of approximately $60.6 million as of September 30, 2025, Cardiff Oncology projects its current cash resources are sufficient to fund operations into the first quarter of 2027.
Exelixis, Inc. (NASDAQ:EXEL) delivered a strong third quarter 2025 performance with total revenues of $597.8 million, including cabozantinib franchise US net product revenues of $542.9 million, driven primarily by increased sales volume in renal cell carcinoma and neuroendocrine tumors. The company presented detailed positive results from the STELLAR-303 pivotal trial at the 2025 European Society for Medical Oncology Congress, demonstrating that zanzalintinib in combination with atezolizumab achieved a statistically significant reduction in the risk of death versus regorafenib in patients with previously treated metastatic colorectal cancer.
"In the third quarter of 2025, Exelixis gained momentum in the cabozantinib franchise and delivered on critical strategic priorities across the research & development portfolio," said Michael M. Morrissey, Ph.D., CEO of Exelixis. "The cabozantinib franchise continued to outperform with sustained growth in renal cell carcinoma and neuroendocrine tumors, where CABOMETYX built on its position as the leading oral therapy for new patient market share in second-line and later settings. Based on these results, we intend to complete the submission of our first new drug application for zanzalintinib in the U.S. before year-end."
Exelixis reported GAAP diluted earnings per share of $0.69 and non-GAAP diluted earnings per share of $0.78 for the quarter, with the company announcing an additional stock repurchase program of up to $750 million by the end of 2026. The company updated 2025 financial guidance to total revenues between $2.30 billion and $2.35 billion, with four ongoing phase 1 clinical studies advancing its early-stage pipeline.
Gilead Sciences, Inc. (NASDAQ:GILD) reported third quarter 2025 product sales excluding Veklury increased 4% year-over-year to $7.1 billion, with Trodelvy sales increasing 7% to $357 million, driven by higher demand in the oncology portfolio. The company presented Phase 3 ASCENT-03 data for Trodelvy in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-1/PD-L1 checkpoint inhibitors at the 2025 European Society for Medical Oncology Congress.
"We continue to deliver on Gilead's robust portfolio with a strong start for Yeztugo, rapidly growing uptake of Biktarvy, Descovy and Livdelzi, and positive data for Trodelvy in 1L metastatic triple negative breast cancer," said Daniel O'Day, Gilead's Chairman and CEO. "With multiple potential product launches in 2026, the strongest clinical pipeline in Gilead's history, and no major loss of exclusivity expected until 2036, we are well-positioned to drive positive impact for patients and continued growth of our business."
Gilead raised its full-year 2025 guidance, now expecting product sales of $28.4 billion to $28.7 billion and diluted EPS of $6.65 to $6.85, supported by consolidated cash, cash equivalents, restricted cash and marketable securities of $9.4 billion as of September 30, 2025. The company announced settlement agreements to resolve Biktarvy patent litigation with generic manufacturers, extending the earliest potential generic entry date to April 1, 2036, more than two years later than the previous loss of exclusivity projection.
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SOURCES CITED:
- https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-with-early-gastric-and-gastroesophageal-cancers.html
- https://www.washingtonpost.com/health/2025/11/05/cancer-pancreatic-drug-fda-trump/
- https://media.market.us/global-immuno-oncology-market-news/
