Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of Care

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, March 19, 2026 /CNW/ -- USANewsGroup.com News Commentary -- The global oncology market is valued at $279.98 billion in 2026 and is on track to reach $748.17 billion by 2035^[1], a structural realignment driven by the shift from single-agent treatments toward synergistic combination platforms and next-gen cell therapies. The immuno-oncology segment alone is projected to expand from $65.22 billion in 2025 to $170.19 billion by 2032^[2], as a wave of combination therapy approvals converts tumors once resistant to immunotherapy into viable targets. Institutions are positioning for this shift through companies like Oncolytics Biotech (NASDAQ: ONCY), Gilead Sciences (NASDAQ: GILD), enGene Holdings (NASDAQ: ENGN), TScan Therapeutics (NASDAQ: TCRX), and Day One Biopharmaceuticals (NASDAQ: DAWN) (soon to be Servier), which are each advancing translational data or near-term regulatory milestones in the 2026 cycle.

Goldman Sachs has projected 2026 will be a record-breaking year for biopharma dealmaking, with pharma and biotech companies remaining the primary target as a patent cliff looms which could result in the loss of hundreds of billions in revenue^[3]. This structural shift creates a window for companies with asymmetric upside in high-value solid tumor markets, as the FDA's expanded accelerated approval framework--now covering gene therapies and next-generation combination regimens--compresses the timeline from translational data to commercial launch, making regulatory milestones the primary value driver for the 2026 immuno-oncology investment cycle^[4].             

Oncolytics Biotech (NASDAQ: ONCY) is presenting new mechanistic and translational data at the American Association for Cancer Research (AACR) Annual Meeting in San Diego this April, data that adds scientific depth to the company's push into some of cancer's hardest-to-treat corners.

The two abstracts, drawn from the AWARE-1 breast cancer study and the GOBLET gastrointestinal cancer trial, both center on the same question: can pelareorep, the company's lead drug, make tumors more vulnerable to immunotherapy? The short answer, based on these findings, appears to be yes. In AWARE-1, biopsies showed pelareorep triggering the formation of tertiary lymphoid structures, essentially localized immune hubs that help the body mount a sustained attack on cancer cells.

Tumors that would otherwise stay "cold" and invisible to the immune system showed signs of becoming "hot." In GOBLET Cohort 1, patients with pancreatic cancer who showed early immune activation after four weeks on a pelareorep-based regimen lived longer without their disease progressing than those who did not, 7.5 months compared to 5.6 months. That same treatment combination previously posted a 62% objective response rate in first-line pancreatic cancer patients, more than double what chemotherapy alone has historically produced.

The data matter because they help explain the results Oncolytics has already reported in colorectal cancer, where the backdrop is equally encouraging. The company recently launched REO 033, a randomized Phase 2 trial testing pelareorep alongside bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, a patient group with very few good treatment options today.

The trial builds on earlier results from REO 022, where the same drug combination produced 27 months of overall survival, 11.2 months of progression-free survival, and a 33% objective response rate, against 16.6 months, 5.7 months, and roughly 10% for the standard of care. The FDA took notice, granting the regimen Fast Track Designation earlier this year. The second-line KRAS-mutant colorectal cancer market is estimated at $3 to $5 billion annually. REO 033 expects to open its first site next month, with preliminary data targeted for year-end 2026.

Oncolytics is a clinical-stage biotechnology company that has spent years building a scientific case for pelareorep across multiple tumor types. Across anal cancer, pancreatic cancer, and now colorectal cancer, the drug is accumulating a consistent body of evidence as something that may make other gastrointestinal cancer treatments work better. That kind of backbone role, if confirmed in larger trials, could position Oncolytics as a meaningful partner in the broader immuno-oncology landscape, where combination strategies are increasingly where the field is heading.

CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

In other industry developments:

Gilead Sciences (NASDAQ: GILD) reported fourth quarter and full year 2025 financial results showing oncology revenues of $3.2 billion for the year, anchored by a 6% increase in Trodelvy sales to $1.4 billion on higher breast cancer demand, while Yescarta received a label update removing a limitation around Primary Central Nervous System Lymphoma, making it the only CAR-T therapy in relapsed or refractory large B-cell lymphoma to have that restriction lifted. The company also presented positive pivotal Phase 2 iMMagine-1 data for its Arcellx-partnered CAR T-cell therapy anitocabtagene autoleucel in 4L+ relapsed or refractory multiple myeloma at the 2025 American Society of Hematology meeting, with two additional cancer therapy launches anticipated in 2026.

"In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease," said Daniel O'Day, Chairman and CEO of Gilead Sciences.

Gilead Sciences closed 2025 with $10.6 billion in cash and marketable debt securities and generated $10.0 billion in operating cash flow for the full year. For 2026, Gilead Sciences guides for total product sales of $29.6 billion to $30.0 billion and non-GAAP diluted EPS of $8.45 to $8.85, with anticipated oncology launches expected to contribute meaningfully to growth alongside continued HIV franchise momentum.

enGene Holdings (NASDAQ: ENGN) reported Q1 2026 financial results reflecting continued advancement of its lead non-viral gene therapy candidate, detalimogene voraplasmid, toward a Biologics License Application submission targeted for the second half of 2026. The company's pivotal LEGEND cohort of 125 BCG-unresponsive NMIBC patients demonstrated a 63% complete response rate at any time and a 62% CR rate at 6 months, while enGene Holdings closed Q1 with $312.5 million in cash and marketable securities.

"As data from LEGEND's pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and CEO of enGene Holdings. "With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."

enGene Holdings expanded its Hercules Capital debt facility to $125 million in January 2026, providing additional non-dilutive capital ahead of its planned commercial launch. The company expects its current cash position to fund operations into the second half of 2028, and 12-month complete response data from the LEGEND pivotal cohort is expected in 2H 2026.

TScan Therapeutics (NASDAQ: TCRX) reported Q4 and full year 2025 financial results while providing updates on its TCR-engineered T cell hematologic malignancies program, including the completion of enrollment in Cohort C of the Phase 1 ALLOHA trial and FDA clearance of INDs for two new CD45-targeting candidates, TSC-102-A01 and TSC-102-A03. Full year 2025 collaboration and license revenue reached $10.3 million versus $2.8 million in 2024, with cash and equivalents of $152.4 million expected to fund operations into 2H 2027.

"The regulatory and operational progress we have made over the last several months related to our heme program is exciting," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan's first Phase 3 trial. The data we presented at ASH in December 2025 continue to support our decision to focus the Company's efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."

TScan Therapeutics discontinued its PLEXI-T solid tumor trial in November 2025 to concentrate resources on hematologic malignancies, and anticipates sharing preclinical proof-of-concept data from its autoimmunity program in 2H 2026. Updated Cohort C data and initiation of a Phase 1 study for TSC-102-A01 and TSC-102-A03 are both expected in the second half of 2026.

Day One Biopharmaceuticals (NASDAQ: DAWN) announced a definitive acquisition agreement under which Servier will acquire all outstanding shares of Day One Biopharmaceuticals for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The offer price represents a premium of approximately 68% over Day One Biopharmaceuticals' closing price on March 5, 2026, and approximately 86% over its one-month volume weighted average price, reflecting significant value recognition for the company's lead pediatric low-grade glioma program and broader oncology pipeline.

"Servier's successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One Biopharmaceuticals' mission to bring medicines to patients of all ages with life threatening diseases," said Jeremy Bender, Ph.D., CEO of Day One Biopharmaceuticals. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma."

The transaction is subject to customary closing conditions, including shareholder tender and U.S. antitrust clearance, and is expected to close in Q2 2026. Day One Biopharmaceuticals' Board of Directors has unanimously recommended that shareholders tender their shares, and Servier expects to fund the acquisition through existing cash and investments.

Article Source: usanewsgroup.com

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SOURCES:

1. https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035
2. https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-as
3. https://www.foley.com/insights/publications/2025/09/patent-cliff-ma-activity-for-companies-right-now/
4. https://www.pharmexec.com/view/fda-s-new-accelerated-approval-draft-guidance

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