Non-small cell lung cancer stage III

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the European Commission. The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) in treatment-naive patients with metastatic NSCLC. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. CStone is actively communicating with regulatory authorities, including the European Medicines Agency (EMA) for marketing authorization applications for additional indications of sugemalimab. CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland, with further collaborations expected soon in regions including Western Europe, Latin America, the Middle East, and Southeast Asia. SUZHOU, China, Oct. 31, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This marks the second overseas approval for sugemalimab following its recent authorization by the European Commission. Dr. Jason Yang, CEO, President of R&D and Executive Director of the Board at CStone, said, "This approval is a significant milestone in our global expansion strategy. Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC." Dr. Yang added, "We are actively pursuing additional partnerships across Western Europe, Latin America, the Middle East, Southeast Asia, and Canada, and expect to finalize some of these agreements shortly. Meanwhile, we are communicating with the European Medicines Agency (EMA) and other agencies for additional regulatory applications for other sugemalimab indications, including Stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, aiming to bring innovative treatment options to more patients globally." The MHRA's approval is primarily based on the data from GEMSTONE-302, a multicenter, randomized, double-blind phase 3 trial. The study demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC. Study results have been published in The Lancet Oncology and Nature Cancer, and have been presented at multiple international academic conferences in both oral and poster sessions. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Research led by the American Cancer Society finds Medicaid expansion was associated with longer survival and reduced treatment delays. PLYMOUTH MEETING, Pa., Oct. 24, 2024 /PRNewswire/ -- New research published online-ahead-of-print in JNCCN—Journal of the National Comprehensive Cancer Network found that people with newly-diagnosed hormone receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-positive breast cancer were more likely to receive timely, guideline-concordant treatment and have longer survival in states that participate in Medicaid expansion under the Affordable Care Act (ACA). Continue Reading "Expanding Medicaid... can help ensure that more patients with cancer benefit from life-saving treatments." Post this Visit JNCCN.org to read the latest new cancer research studies. A team of researchers—led by the American Cancer Society (ACS), and including Kathryn J. Ruddy, MD, MPH, of the Mayo Clinic Comprehensive Cancer Center, a former NCCN Foundation® Young Investigator Award recipient—used data from the National Cancer Database (NCDB) to review results for women across the United States, age 18-62, who were diagnosed with this type of breast cancer between 2010 and 2018. 19,248 of the patients lived in Medicaid expansion states, while 12,153 resided in non-expansion locations. In the expansion states, the 2-year survival rate increased from the 2010 baseline rate of 93.9% to 95.0% across the study period. However, in the non-expansion states, 2-year survival declined slightly from 94.0% to 93.9%. The biggest difference was seen in patients with Stage III disease. "Expanding Medicaid to the 10 states that have yet to do so can help ensure that more patients with cancer benefit from life-saving treatments," said lead researcher Kewei Sylvia Shi, MPH, Surveillance and Health Equity Science, American Cancer Society. "It's crucial to increase access to oncology services, expand insurance coverage, and streamline diagnostic and referral processes. Stage III cancer represents a critical point in disease presentation and can further progress and become incurable if undertreated. Having health insurance coverage will make it more likely for these patients to receive timely and comprehensive access to life-saving therapies, have better medication adherence, and complete treatment, which leads to better survival outcomes." HR-negative, HER2-positive breast cancer is an aggressive subtype that accounts for approximately 5% of all breast cancer diagnoses.1 This is the first study to focus on the impact of Medicaid expansion on that specific population. The study found that treatment according to recommendations from evidence-based, expert consensus driven clinical practice guidelines—such as the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)— was more likely to begin within 90 days from diagnosis in the expansion states. "This study reinforces the important role Medicaid expansion plays in ensuring that women newly diagnosed with HR-negative, HER2-positive breast cancer have equitable access to the healthcare services they need—especially when prognosis depends on access to treatment," said Millicent Gorham, CEO of the Alliance for Women's Health and Prevention, who was not involved in this research. "Breast cancer is far too common, and rates are increasing among younger women, making it critical that policymakers also prioritize women's access to preventive health screenings and appropriate treatments." To read the entire study, visit JNCCN.org. Complimentary access to "Association of Medicaid Expansion With Timely Receipt of Treatment and Survival Among Patients With HR-Negative, HER2-Positive Breast Cancer" is now available online. The article will also be featured in the November 2024 print edition of the journal. About JNCCN—Journal of the National Comprehensive Cancer Network More than 25,000 oncologists and other cancer care professionals across the United States read JNCCN—Journal of the National Comprehensive Cancer Network. This peer-reviewed, indexed medical journal provides the latest information about innovation in translational medicine, and scientific studies related to oncology health services research, including quality care and value, bioethics, comparative and cost effectiveness, public policy, and interventional research on supportive care and survivorship. JNCCN features updates on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), review articles elaborating on guidelines recommendations, health services research, and case reports highlighting molecular insights in patient care. JNCCN is published by Harborside/BroadcastMed. Visit JNCCN.org. To inquire if you are eligible for a FREE subscription to JNCCN, visit NCCN.org/jnccn/subscribe. Follow JNCCN at x.com/JNCCN. About the National Comprehensive Cancer Network The National Comprehensive Cancer Network® ( NCCN ®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information. Media Contact: Rachel Darwin 267-622-6624 [email protected] 1 National Cancer Institute. Cancer stat facts: female breast cancer subtypes. Available at: SOURCE National Comprehensive Cancer Network WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HAYWARD, CA, USA I October 02, 2024 I Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced a clinical trial collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate casdatifan (AB521), Arcus’s investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in patients with ccRCC. “We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC.” “Renal cell carcinoma is a known CTLA-4-responsive tumor type, and our first-in-human study with volrustomig monotherapy demonstrated encouraging efficacy in first-line advanced ccRCC,” said Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca. “We are excited by the potential to build on this by combining HIF-2a inhibition with volrustomig to drive deeper and more durable responses for patients.” As part of this collaboration, AstraZeneca will sponsor and operationalize a study to evaluate the safety and early efficacy of the casdatifan plus volrustomig combination in patients with advanced ccRCC. This is the second clinical collaboration between Arcus and AstraZeneca. In 2020, the companies announced a clinical collaboration for PACIFIC-8, a registrational Phase 3 study of domvanalimab, an Fc-silent anti-TIGIT antibody, added to backbone global standard-of-care durvalumab, an anti-PD-L1 antibody, in patients with unresectable Stage III non-small cell lung cancer. Under the Gilead and Arcus collaboration agreement, Gilead has the right to opt-in to development and commercialization for casdatifan after Arcus’s delivery of a qualifying data package. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor involved in oxygen sensing in multiple organs as well as in tumors. Clear cell RCC is almost universally associated with HIF-2a dysregulation as a result of genetic abnormalities in the VHL pathway. This creates a situation of pseudohypoxia and the abnormal increase in HIF-2a-mediated expression of a wide array of proteins involved in cancer cell proliferation and survival, treatment resistance and angiogenesis. Casdatifan is being evaluated in ARC-20, a Phase 1/1b study in cancer patients, and STELLAR-009, a Phase 1b/2 study in combination with zanzalintinib in patients with advanced solid tumors, including ccRCC. Casdatifan and domvanalimab are investigational molecules. Approval from any regulatory authority for any use of these molecules globally has not been received, and their safety and efficacy have not been established. About RCC According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 81,600 Americans will be diagnosed with kidney cancer in 2024. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 15%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39, and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com . SOURCE: Arcus Biosciences