Currently, the prostate-specific antigen (PSA) test is widely used to identify men who are at an increased risk of prostate cancer based on factors like age and ethnicity, as well as those showing symptoms. Elevated PSA levels may indicate prostate cancer, prompting further investigations such as MRI scans, biopsies, and treatments. However, the PSA test often results in false positives—incorrectly indicating prostate cancer in three out of four instances. It also detects cancers that grow so slowly they are unlikely to pose a significant health threat, leading to potentially unnecessary medical procedures. Now, a saliva-based test that individuals can perform at home has proven better at predicting the risk of developing prostate cancer than the traditional blood test. Researchers from The Institute of Cancer Research (London, UK) and The Royal Marsden NHS Foundation Trust (London, UK) conducted a trial of this innovative DNA test that screens for genetic variants associated ...
AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology. By Frank VinluanAstraZeneca, which already has a strong presence in lung cancer, is poised to deepen its reach in the disease with clinical data that support expanding the use of two of its approved therapies in ways that clinicians say will change the standard of care for many patients. The data are set for presentation Sunday during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. First up is the targeted therapy osimertinib, which is marketed under the brand name Tagrisso. The small molecule blocks mutated forms of the EGFR protein, which drives cancer growth. The drug is already approved for use as a first-line treatment ...
Novartis recently presented positive results from the pivotal Phase III ASC4FIRST study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting: the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) with Scemblix® at Week 48 demonstrated greater efficacy and safety than the investigator’s choice of tyrosine kinase inhibitors (TKIs) (imatibe Scemblix demonstrated a superior major molecular response (MMR) rate at week 48 than both investigator-selected tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib) and imatinib alone.Scemblix demonstrated a higher MMR rate at week 48 than the second-generation TKIs (nilotinib, dasatinib, and bosutinib) with higher rate values.The MMR rate was higher than that of the second-generation TKIs. In addition, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment interruptions relative to imatinib and second-generation TKIs. Tim Hughes, M.D., professor at the South Australian ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer. The CHMP’s opinion on ...
GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
NANJING, China, June 3, 2024 /PRNewswire/ — The annual meeting of the American Society of Clinical Oncology (ASCO) commenced on May 31st, Showcasing groundbreaking cancer research from around the world. According to official information, over 7,000 abstracts were submitted this year. After rigorous evaluation by Scientific Program Committee and ASCO Leadership, LBL-024, a bispecific antibody independently developed by Leads Biolabs with global intellectual property rights, was selected for an oral presentation. Today, Dr. Panpan Zhang, the investigator of LBL-024, presented the outstanding clinical data during the Clinical Science Symposium-Building Novel Antibody-Based Approaches in Gastrointestinal Cancers. This is a phase I/II first in human, open-label, multicenter, dose escalation/expansion study that evaluates the safety and efficacy of LBL-024 monotherapy in patients with advanced malignant tumors and neuroendocrine carcinoma. The study results demonstrated good safety profile and very promising antitumor effects as a monotherapy in patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine ...
Davy James Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor.1 The regulatory action marks the fourth indication for Breyanzi to treat a distinct subtype of non-Hodgkin lymphoma. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, BMS, said in a press release. “We are proud of the advances we are making to bring our differentiated CAR T cell therapy to the most patients across indications and lines of therapy to ensure treatment options that ...
Don Tracy, Associate Editor Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Merck has announced that the FDA granted Priority Review designation to its application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. According to the company, the application was a based on positive data from the Phase II/III IND.227/KEYNOTE-483 trial, which found that Keytruda in combination with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Further, death was reduced by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. After a year of treatment, the estimated PFS ...
Genentech, a member of the Roche Group, announced that the USFDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The priority review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57 per cent compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95 per cent CI: 0.32-0.59, p<0.0001) in the first-line setting. Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed ...
High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology ...
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