Elranatamab

The FDA seems to be getting the hang of its new speedy voucher system. Just two and a half months after awarding a Commissioner's National Priority Voucher (CNPV) to Johnson & Johnson's multiple myeloma (MM) combination, the US regulator has already approved the treatment regimen.The agency on Thursday cleared anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) to treat adults with relapsed or refractory MM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. J&J is the second CNPV recipient to win an FDA nod within the past week. At the end of February, Boehringer Ingelheim's Hernexeos (zongertinib) got an OK from the FDA to treat frontline HER2-mutated non–small-cell lung cancer. The programme has not been without stumbles, however. Reviews for Eli Lilly's orforglipron and Sanofi's Tzield (teplizumab-mzwv) were reportedly delayed in January, and Disc Medicine, an early voucher recipient, got a surprise snub from the FDA last month. The first FDA approval sped up by a CNPV went to a US-manufactured version of the antibiotic Augmentin XR (amoxicillin-clavulanate potassium) in December. MajesTEC MM survival dataThe CNPV for Tecvayli and Darzalex Faspro, as well as the duo's regulatory win in second-line MM, were driven by findings from the Phase III MajesTEC-3 study.At the American Society of Hematology (ASH) conference last year, J&J revealed findings from MajesTEC-3 showing that Tecvayli plus Darzalex Faspro combo led to three-year progression-free survival (PFS) and overall survival (OS) rates exceeding 83%, compared to around 30% and 65%, respectively, for the comparator arm (see – Spotlight On: J&J's eye-popping MajesTEC-3 data a win for Tecvayli, MM bispecifics)."This new treatment option can redefine how we approach RRMM [relapsed/refractory MM] treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterised safety profile," said Luciano J. Costa, MajesTEC-3's primary investigator. "The option to use this regimen as early as second line is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical."And based on the results of a recent FirstWord poll, physicians are likely eager to use the combination in the second-line setting. A survey of US haemotologists and oncologists showed that Tecvayli is the preferred bispecific to treat MM for nearly half of the respondents, beating other similar products including J&J's own Talvey (talquetamab), Pfizer's Elrexfio (elranatamab) and Regeneron's Lynozyfic (linvoseltamab). For more on which treatments doctors are picking for their MM patients, see Physician Views In-Depth: US oncologists heavily favour Tecvayli among MM bispecifics.

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC , March 5, 2026 /PRNewswire/ -- Equity-Insider.com News Commentary — The five-year cancer survival rate in the United States has reached a record 70%, reflecting decades of progress in early detection, targeted therapy, and immunotherapy [1] . Yet cancer remains the second-leading cause of death worldwide, with an estimated 2.1 million new diagnoses expected in 2026 alone and mortality rates still climbing among younger populations [2] . Companies delivering next-generation oncology treatments across multiple tumor types include Oncolytics Biotech (NASDAQ: ONCY), Vir Biotechnology (NASDAQ: VIR), Iovance Biotherapeutics (NASDAQ: IOVA), C4 Therapeutics (NASDAQ: CCCC), and Immunocore (NASDAQ: IMCR). The global oncology market is projected to nearly triple from $279.98 billion to $748.17 billion by 2035, with North America commanding a 43% market share [3] . The immuno-oncology segment alone is expected to grow at a compound annual rate of approximately 21% over the next five years, driven by checkpoint inhibitors, cell therapies, and cancer vaccines collectively redefining standards of care [4] . Oncolytics Biotech (NASDAQ: ONCY) has launched a study that could reshape how doctors treat one of the most stubborn forms of colorectal cancer. The company's randomized Phase 2 trial, REO 033, will evaluate pelareorep in combination with bevacizumab and FOLFIRI in second-line RAS-mutated (which includes KRAS), microsatellite-stable metastatic colorectal cancer, a patient population where current treatments offer limited benefit and new options are urgently needed. "I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey . "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration." The confidence behind REO 033 stems from compelling data generated in a previous clinical study. Pelareorep combined with bevacizumab and FOLFIRI demonstrated 27 months of overall survival and 16.6 months of progression-free survival, compared to 11.2 and 5.7 months for the standard of care. Objective response rate was 33% versus approximately 10% for the standard of care, more than tripling the benchmark in a notoriously difficult-to-treat population. Notably, this treatment regimen was granted Fast Track Designation by the FDA earlier this year. "The potential to improve clinical outcomes compared to the standard of care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center . "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more patients being diagnosed with colorectal cancer." The global market for second-line treatment in KRAS-mutant, microsatellite-stable metastatic colorectal cancer runs between $3-5 billion annually . The study will randomize 60 patients to either the pelareorep combination or a control arm of bevacizumab and FOLFIRI, with objective response rate as the primary endpoint. Oncolytics expects to open the first study site later this month, with additional clinical sites added in quick succession, and preliminary data is expected by year-end 2026. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: Vir Biotechnology (NASDAQ: VIR) has reported positive Phase 1 results for VIR-5500, a PSMA-targeting T-cell engager in metastatic prostate cancer. Dose-dependent anti-tumor activity was observed, with 82% PSA50 and 53% PSA90 declines and objective responses in 45% of RECIST (Response Evaluation Criteria in Solid Tumors)-evaluable patients at higher dose cohorts, representing a meaningful signal in a heavily pretreated population. "We are encouraged by VIR-5500's safety and tolerability pro the early signals of durable anti-tumor activity in a heavily pre-treated population, which validate our PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index," said Marianne De Backer, CEO of Vir Biotechnology . "Based on these data, we are advancing dose-expansion cohorts and plan to initiate our registrational trial in 2027. We want to thank the patients in our Phase 1 program and their families for participating in the development of VIR-5500." The company has entered a global collaboration with Astellas to develop and commercialize VIR-5500, providing financial validation of the PRO-XTEN platform's potential to address unmet needs across solid tumor indications. Iovance Biotherapeutics (NASDAQ: IOVA) has announced positive results from the first clinical trial of TIL cell therapy in advanced undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS). The study demonstrated a 50% objective response rate with one-time treatment of li in soft tissue sarcoma subtypes where treatment options remain severely limited. "In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with li demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care," said Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist at Memorial Sloan Kettering Cancer Center . "Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026." Iovance's AMTAGVI became the first FDA -approved TIL therapy in February 2024, establishing the company as the pioneer in commercially available tumor-infiltrating lymphocyte treatments. C4 Therapeutics (NASDAQ: CCCC) has dosed the first patient in the Phase 2 MOMENTUM trial of cemsidomide, an oral IKZF1/3 degrader for relapsed or refractory multiple myeloma. The study will evaluate cemsidomide in combination with dexamethasone, building on the compelling anti-myeloma activity observed in early-phase studies. "Initiating the Phase 2 MOMENTUM trial, which builds upon the compelling anti-myeloma activity and differentiated safety pro in the Phase 1 trial, is a critical step for cemsidomide to become a foundational therapy for multiple myeloma patients, who are in need of a safe, oral, and convenient treatment option," said Len Reyno, Chief Medical Officer of C4 Therapeutics . "With this milestone accomplished, we are also on track to initiate the Phase 1b trial of cemsidomide in combination with elranatamab in the second quarter, as we continue to advance our regulatory strategy that could deliver two accelerated approval paths in multiple myeloma." The company is also advancing a Phase 1b combination study with elranatamab on track for the second quarter of 2026. Oral targeted protein degradation represents a growing modality in hematologic oncology, with multiple companies racing to validate degrader-based approaches in myeloma. Immunocore (NASDAQ: IMCR) has reported results headlined by $400 million in KIMMTRAK sales for full-year 2025, a 29% increase year over year. The ImmTAC platform is advancing clinical programs across melanoma, non-small cell lung cancer, and additional solid tumor indications. "With $400 million in KIMMTRAK sales and a diverse clinical portfolio, Immunocore had a productive year of growth and progress," said Andrew Baum, CEO of Immunocore . "Our priority for 2026 is the clear execution of our clinical trials, particularly as we anticipate key data in oncology and begin our first trial in autoimmune disease. We remain focused on the long-term goal of developing medicines that can significantly improve patient lives." Immunocore's ImmTAC platform engineers bispecific T-cell receptors capable of redirecting the immune system to recognize intracellular cancer targets, a fundamentally different approach from checkpoint inhibitors or cell therapies. Article Source: equity-insider.com CONTACT: EQUITY INSIDER info@equity-insider.com (604) 999-4849 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. 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