A blood test measuring levels of the protein cancer antigen 125 (CA125) can help detect ovarian cancer in a primary care setting with considerable accuracy, a study reported. The research also showed for a first time that this test can also help in identifying other cancer types, particularly in women ages 50 and older. The…
Conditions
Conditions
UK Study to Assess Causes of Greater Prostate Cancer Risk Among Black Men
Enrollment has resumed in a five-year U.K. study investigating genetic factors behind the higher risk of prostate cancer in men of African and Caribbean descent. The study involves researchers at The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, in London, who will run initial biopsy and genetic profiling tests. Black men…
Keytruda-Chemo Combo Improves Survival Outcomes in Advanced Lung Cancer
First-line treatment with a combination of Keytruda (pembrolizumab) plus chemotherapy significantly prolongs survival, and extends life without disease progression, in people with advanced non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 status, results from a Phase 1/2 trial show. Compared with platinum-based chemotherapy alone, the combo treatment also led to higher response rates in…
Allogene to Present Positive Phase 1 Data for Investigational CAR T-cell Therapy ALLO-715
ALLO-715, an investigational donor-derived CAR T-cell therapy by Allogene Therapeutics, has a manageable safety profile and promising preliminary efficacy results in people with relapsed or refractory multiple myeloma, a Phase 1 clinical trial has shown. The results will be presented at the 62nd Annual Meeting of the American Society of Hematology, taking place virtually in…
FDA Clears Neuraly to Begin Phase 2 Trial of NLY01 in Alzheimer’s Patients
The U.S. Food and Drug Administration has given clearance for a Phase 2B clinical trial to evaluate the safety, tolerability, and efficacy of Nueraly‘s investigational therapy NLY01 in people with Alzheimer’s disease. The randomized, double-blinded, placebo-controlled trial is expected to enroll more than 500 people with mild cognitive impairment due to Alzheimer’s disease at more…
Myeloma UK Calls for More Data Transparency to Safeguard Patients From COVID-19
Myeloma UK is calling for more data transparency in government efforts to safeguard myeloma patients during the COVID-19 pandemic. This comes after results were released from its COVID-19 survey that sought to examine the rate of COVID-19 infection among myeloma patients, changes to planned treatment due to the viral outbreak, and how the unfolding pandemic…
Approval of Injection Darzalex Combo for Advanced Myeloma Sought in US, EU
Janssen is seeking to extend approval of its under-the-skin formulation of Darzalex (daratumumab) to include its use in combination with Pomalyst (pomalidomide) and dexamethasone to treat relapsed or refractory multiple myeloma patients who received at least one prior line of therapy. The company submitted applications for this combination therapy to regulatory agencies in the U.S. and the European Union. Darzalex…
ImmunoGen Teams Up With Huadong Medicine to Develop Mirvetuximab in China
ImmunoGen has announced a collaboration with Hangzhou Zhongmei Huadong Pharmaceutical Co, a subsidiary of Huadong Medicine, to develop and commercialize the ovarian cancer treatment mirvetuximab soravtansine to patients in China, Hong Kong, Macau, and Taiwan. The partnership will combine ImmunoGen’s expertise in cancer medication development with Huadong Medicine’s familiarity with regulatory agencies and connections to…
AI-enabled Software To Detect Prostate Cancer Bone Metastases Clears FDA
An artificial intelligence (AI) program that aims to make it easier to identify bone metastases in men with prostate cancer has been granted 501(k) clearance by the U.S. Food and Drug Administration (FDA), its developer announced. The program uses a neural network — a type of AI — to identify hotspots on bone scans indicative of bone…
Last Participant Finishes PEGASUS Clinical Trial, Results Expected Next Year
The last participant has completed the planned 24 weeks in the Phase 2 PEGASUS clinical trial, which is assessing the safety and biological activity of Amylyx Pharmaceuticals‘ investigational therapy AMX0035 in people with Alzheimer’s disease. Top-line results from the trial are expected in the first half of 2021. “The PEGASUS trial design and broad inclusion…
FDA Approves Keytruda-chemo Combo for Advanced TNBC Positive for PD-L1
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), in combination with chemotherapy, to treat people with advanced triple-negative breast cancer (TNBC) and at least 10% of tumor cells positive for PD-L1. The indication includes patients with locally recurrent and inoperable or metastatic tumors, not previously treated with chemotherapy. Tumor PD-L1 status will be…
Phase 3 Study of Epcoritamab for Advanced DLBCL to Open in Europe, Australia
Genmab is launching a Phase 3 clinical trial investigating its bispecific antibody epcoritamab as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients who fail to respond to, or are ineligible for, autologous stem cell transplant (ASCT). The open-label trial (NCT04628494) is expected to enroll up to 480 people whose tumors are positive…