Pembrolizumab/Hyaluronidase

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 24, 2026 /PRNewswire/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD). The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval. The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication. With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs. "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution." The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment. KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026. Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy. The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer. "The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis. The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise. Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population. "We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities. Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. "For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute. The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo. Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation. "This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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iStock, Deagreez Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue. As Merck’s oncology juggernaut Keytruda heads toward its curtain call as the highest selling drug, a new analysis from Bloomberg Intelligence suggests that the PD-1 inhibitor could have more exclusivity time than key 2028 patent expirations would suggest. That could mean an additional $22 billion in sales for Merck. Consensus estimates have generally suggested that Merck will start to see erosion in 2029 as copycat versions of the checkpoint inhibitor enter the market. Sandoz and Bio-Thera are already working on rival products. But Bloomberg Intelligence (BI) argues that Merck’s global patent portfolio will extend the timeline, with erosion arriving more starkly in about 2033. This could mean sales of about $22 billion for $13 billion in profit from 2030 to 2033, the firm wrote. “Merck’s global patent portfolio protecting its blockbuster cancer drug Keytruda is dense and strategically layered to provide solid protection across jurisdictions, with its structure exactly what we’d expect to see for well thought-out coverage for such a product,” BI wrote. Keytruda brought home $31.7 billion in 2025—49% of Merck’s total revenue. The stakes are high. Careful Planning Merck has always based the timeline of Keytruda’s exclusivity future on the December 2028 expiry date for the first patent ever CEO Robert Davis told analysts on the company’s fourth quarter earnings call earlier this month. However, because case law has advanced since the original filing, the company now has more confidence in its ability to defend all of its Keytruda patents. Nevertheless, Davis said, “for planning purposes we continue to assume 2028 because I think that’s a conservative assumption. We’ll have to see where it goes.” Patents Proliferating Patents, Lawsuits Stave Off Pharmas’ Generic Competitors An analysis finds that pharmas frequently similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors. February 18, 2026 · 4 min read · Shawna Williams Read More The company’s executives have suggested that the cliff will be more of a hill. BI’s new analysis supports that take, with the firm predicting that Keytruda’s patent cliff may be more of a “gradual earnings slope.” Keytruda is approved for more than 20 different types of cancer and more than 40 indications with 30 large global patent families protecting it across compositions of matter, formulations and methods of treatment, including dosing regimens. The active ingredient itself, pembrolizumab, is covered, as are certain combinations, formulations and dosing regimens. Some of the relevant patents don’t expire until 2039, BI said. Merck also received approval in September 2025 for a subcutaneous version called Keytruda Qlex, which has essentially restarted the patent clock with coverage through 2041. Guggenheim Securities also forecasts that the approval of Keytruda Qlex will help flatten out the cliff. The pharma is benefitting from dosing convenience versus competitors—Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq—and recent changes to drug pricing legislation that will impact the drug. BioSpace /Annalee Armstrong BI noted that Keytruda will face a Medicare price cut under the Inflation Reduction Act in 2029, which will alter sales outcomes. Depending on the negotiated price, Merck could see closer to $15 billion in sales and $9 billion in profit, rather than $22 billion in sales and $13 billion in profit, BI said. BMS’ rival drug Opdivo will also face biosimilar competition with sales beginning to erode around the 2029 timeline, BI said. This change in the treatment paradigm could also impact Keytruda, as physicians substitute therapies. With all this said, BI warned that litigation from pending biosimilar competitors is likely, so timelines could change. But Merck could have more time to shore up its post-Keytruda revenue, via conversions to Keytruda Qlex and by bolstering its pipeline via M&A. If Keytruda hangs on and brings home that extra $13 billion in profit, Merck will have even more to work with for those future deals, BI noted. “Biosimilar competition is coming and Keytruda revenue and profit will fall, yet Merck has more time to grow its revenue base and for a numerically strong, late-stage pipeline to mature, launch and contribute increased sales and profit.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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