Metastatic Esophageal Squamous Cell Carcinoma

BeiGene’s Tevimbra (tislelizumab) has been recommended by the European Medicines Agency’s human medicines committee as a first-line treatment for gastric and oesophageal cancer patients. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the PD-1 inhibitor be used in combination with platinum- and fluoropyrimidine-based chemotherapy to treat adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, and in combination with platinum-based chemotherapy to treat adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC). Those eligible for the drug will also have tumours that express PD-L1 with a tumour area positivity (TAP) score of at least 5%, according to the recommendations. Gastric cancer is the fifth leading cause of cancer-related deaths globally, while oesophageal cancer is the sixth. Tevimbra is already approved in the EU for certain cases of advanced or metastatic ESCC after prior platinum-based chemotherapy, and for three non-small cell lung cancer indications covering both the first- and second-line settings. The CHMP’s decision for Tevimbra in G/GEJ cancer was based on positive results from the late-stage RATIONALE-305 trial, in which BeiGene’s drug in combination with investigator’s choice of chemotherapy resulted in a 20% reduction in the risk of death compared to placebo plus chemotherapy in patients with advanced unresectable or metastatic G/GEJ cancer. This benefit rose for patients expressing PD-L1 with a TAP score of at least 5%, with Tevimbra-chemotherapy demonstrating a 29% reduction in the risk of death compared to the placebo arm in this population. The committee’s recommendation in ESCC was supported by results from the phase 3 RATIONALE-306, which showed a 34% reduction in the risk of death for Tevimbra in combination chemotherapy versus placebo plus chemotherapy for patients unresectable, locally advanced recurrent or metastatic ESCC. Three-year overall survival in patients expressing PD-L1 with a TAP score of at least 5% was also substantially improved in favour of the Tevimbra arm, demonstrating a 38% reduction in the risk of death. Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC, who face a poor prognosis and limited treatment options.” The European Commission will now consider the CHMP’s recommendations as it makes a final decision on Tevimbra in these indications.

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Oct. 4, 2024 /PRNewswire/ -- USA News Group News Commentary – While some forms of cancer are seeing death rates fall, the world is witnessing a global surge in cancers among patients under 50. New cases are rising 79% overall, with the fastest rise in windpipe and prostate cancers and the heaviest death toll for cancers of the breast, windpipe, lung, bowel, and stomach. According to the United Nations, cancer rates are set to rise 77% by 2050. In an effort to fight back against cancer, researchers are working on new therapies and making gains, with the FDA issuing 16 oncology approvals between July and September 2024. Behind the scenes, biotech developers are making advancements, with recent market updates coming from: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie (NYSE: ABBV), BeiGene, Ltd. (NASDAQ: BGNE), HUTCHMED (China) Limited (NASDAQ: HCM), and Enliven Therapeutics, Inc. (NASDAQ: ELVN). According to analysts at Spherical Insights, the global oncology drug market is poised to grow at a CAGR of 11.5% towards US$564.50 billion by 2033. As well, the Global AI in Oncology Market is growing at a rapid 35% CAGR, towards US$13.6 billion by 2032. Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced key progress and upcoming studies for its flagship asset pelareorep, an intravenously delivered immunotherapeutic agent in its ongoing trials for breast and pancreatic cancer treatment. Recent clinical efficacy results from Oncolytics' BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated FDA approval. As well, Oncolytics states in the corporate update that key milestones in its gastrointestinal cancer clinical trials are expected in 2025, with potential for new registration-enabling studies. "We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic." The strong efficacy results from BRACELET-1 provide the foundation for a large clinical study designed to support an accelerated approval. Early in 2025, Oncolytics plans to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on antibody-drug conjugates (ADCs) like Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs, which represents a patient population of approximately 55,000 patients in the US. The study design has sufficient statistical power to deliver a p-value of < 0.05 with a progression-free survival (PFS) benefit of ≥4.3 months. Notably, the BRACELET-1 study demonstrated a 5.7-month benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone. Enrollment in the registration-enabling study is expected to commence in the first half of 2025. "With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. " Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways. Our thorough understanding of pelareorep's mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER- breast cancer patients within the current treatment approach." Oncolytics anticipates several key milestones in 2025. In the first half of the year, the company plans to initiate a registrational study of pelareorep combined with paclitaxel in HR+/HER2- breast cancer. Also expected in H1 2025 are safety run-in data from cohort 5 of the GOBLET study, which is investigating pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, in newly diagnosed pancreatic cancer, as well as updated efficacy data from cohort 4 of the GOBLET study focused on pelareorep and atezolizumab in second-line or later anal cancer. Once the master protocol has been finalized with the Global Coalition for Adaptive Research ( GCAR) for the pelareorep combination therapy, Oncolytics intends to approach the FDA before the end of the year. In the second half of 2025, Oncolytics expects initial efficacy results from cohort 5 of the GOBLET study in pancreatic cancer patients. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: AbbVie (NYSE: ABBV), a leading global pharmaceutical company, recently announced the submission of a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. With approximately 85% of lung cancers classified as NSCLC, and lung cancer as the leading cause of cancer-related deaths in the world, Teliso-V is being evaluated with patients with a particular type of NSCLC patient with a c-Met protein overexpression that's associated with a poor prognosis. "Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology." BeiGene, Ltd. (NASDAQ: BGNE), a global oncology company, recently announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) recognized the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%. The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 (G/GEJ) and RATIONALE-306 (ESCC) studies, as well as other pivotal studies from the two other PD-1 inhibitors approved in these indications. "The vote by ODAC members to recommend a class-level cut-off of PD-L1 expression for PD-1 inhibitors used in the treatment of gastric/GEJ cancers and ESCC will help to establish a standard for clinicians and the patients they treat," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to working with the FDA as it completes its review of our BLAs for TEVIMBRA, and we strive to bring this therapy to applicable patients in the U.S." HUTCHMED (China) Limited (NASDAQ: HCM), a Hong-Kong-based international targeted therapeutics and immunotherapies developer for cancer and immunological diseases, recently announced that its partner Takeda received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC). " Takeda has now obtained approval in Japan for FRUZAQLA®, demonstrating the strength of our global data package and the potential of this novel medicine to provide a much-needed treatment option to patients with metastatic CRC," said Dr Weiguo Su, CEO and CSO of HUTCHMED. " Takeda has been a leader in metastatic CRC treatment in Japan for over a decade and we are confident that it is well placed to bring FRUZAQLA® to patients in Japan." Enliven Therapeutics, Inc. (NASDAQ: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, recently announced positive data from the Phase 1 clinical trial evaluating ELVN-001, a potent, highly selective, potentially best-in-class small molecule kinase inhibitor, in patients with chronic myeloid leukemia (CML) that has failed, or the patient is intolerant to or not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377). "We continue to see categorical improvements in molecular response, and the drug remains well-tolerated with an encouraging safety profile," said presenting investigator Fabian Lang, M.D., from Goethe University Hospital Frankfurt. "Despite recent advancements in the CML treatment paradigm, there continues to be a need for more efficacious and better tolerated active-site TKIs, especially for patients who have failed treatment with allosteric inhibitors. I remain excited to see the progress of ELVN-001 as the trial continues." 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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LOUISVILLE, Ky., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Beigene for Tevimbra® (tislelizumab), approved for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. This indication was approved based on the Phase III RATIONALE-302, (NCT03430843) clinical trial, which compared Tislelizumab to systemic chemotherapy.1 Tevimbra® (tislelizumab) is a PD-1 inhibitor that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response. Esophageal cancer (EC) is the sixth most common cause of cancer-related deaths. ESCC is the most common histologic subtype of EC, accounting for nearly 90% of ECs. Esophageal cancer is a rapidly fatal disease. Over two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.2 “Onco360 is grateful for the opportunity to expand our partnership with the team at BeiGene and become the exclusive national specialty pharmacy provider for Tevimbra®,” said Benito Fernandez. “The FDA approval of Tevimbra represents a new treatment option for patients suffering from unresectable or metastatic esophageal cancer, and as a chosen provider, we remain committed to providing patients, their caregivers, and providers with the highest level of quality and service.” The FDA approval of Tevimbra® is based on the results of the Phase III RATIONALE-2 clinical trial, which evaluated 512 adult patients with unresectable advanced or metastatic esophageal (ESCC), randomized 1:1 to receive Tevimbra® 200mg IV every 3 weeks or investigator’s choice IV systemic chemotherapy (paclitaxel, docetaxel, or irinotecan). All patients had received at least one prior anti-cancer systemic therapy. RATIONALE-302 demonstrated a statistically significant improvement in overall survival (OS) for patients randomized to Tevimbra® as compared with systemic chemotherapy. The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased glucose (46%), decreased hemoglobin (45%), decreased lymphocytes (43%), decreased sodium (34%), decreased albumin (33%), increased alkaline phosphatase (32%), anemia (31%), fatigue (28%), increased AST (27%), musculoskeletal pain (24%), decreased weight (23%), increased ALT (23%), and cough (22%). Please see the full Prescribing Information for Tevimbra® About Onco360 Oncology Pharmacy:Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com. Media Contact: Benito Fernandez, Chief Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332 References: Lin Shen et al., RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma. JCO 39, 4012-4012(2021). National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html.