Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
Merck’s Keytruda Plus Eisai’s Lenvima Could Open New Standard of Care in Renal Cancer
Blockbusters, Checkpoint Inhibitors, Clinical Data, Clinical Trials, Combination Therapies, Exploratory Analysis, Keytruda, Merck, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), R&D, Renal Cell Carcinoma (RCC), TherapeuticsMerck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
New Data Reinforce Long-Term Benefit of Venclexta-Based Combination for Relapsed or Refractory CLL
American Society of Hematology (ASH) Annual Meeting, Blockbusters, Chronic Lymphocytic Leukemia (CLL), Clinical Trials, Data, Minimal Residual Disease (MRD), Progression-Free Survival (PFS), R&D, TherapeuticsRoche Group member Genentech announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease.
Five Prime Therapeutics Inc., in collaboration Zai Lab Limited on the development of bemarituzumab – a novel therapy for front-line advanced non HER2+ gastric or gastroesophageal junction (GEJ) cancer – announced groundbreaking positive topline Phase II results.
Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?
Blockbusters, Clinical Data, Clinical Trials, Combination Therapies, Overall Response Rate (ORR), Overall Survival (OS), Primary Endpoints, Progression-Free Survival (PFS), R&D, Renal Cell Carcinoma (RCC), Secondary Endpoints, Therapeutics, Topline DataMerck and Eisai announced new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
Denmark-based Genmab A/S announced positive topline data from the second part of the Phase III CASSIOPEIA trial evaluating daratumumab (marketed as Darzalex) monotherapy as maintenance treatment compared to observation for patients with newly diagnosed multiple myeloma that are eligible for autologous stem cell transplant.
Junshi’s Checkpoint Inhibitor Ready to Head to Regulators for Throat Cancer
Biologics License Application (BLA), Checkpoint Inhibitors, China, China National Medical Products Administration (NMPA), Clinical Trials, Conditional Approval, FDA/Regulatory, Interim Analysis, Nasopharyngeal Carcinoma (NPC), Progression-Free Survival (PFS), R&D, Throat CancerJunshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.
Bristol Myers’ Opdivo with Exelixis drug cuts kidney cancer death risk: study
Analysts, Blockbusters, Clinical Data, Clinical Trials, Combination Therapies, European Society for Medical Oncology (ESMO), Immunotherapies, Kidney Cancer, Progression-Free Survival (PFS), R&D, Renal Cell Carcinoma (RCC), Researchers, TherapeuticsBristol Myers’ Opdivo with Exelixis drug cuts kidney cancer death risk: study NEW YORK (Reuters) – Bristol Myers Squibb Co’s cancer immunotherapy Opdivo in combination with Exelixis Inc’s Cabometyx reduced the risk of death by 40% in previously untreated patients with advanced kidney cancer, according to data from a late-stage study to be presented on […]
Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston
Allogeneic Cells, Boston, Business, Cell Therapy, Clinical Data, Clinical Trials, Facilities/Sites/Manufacturing, Immuno-oncology, Massachusetts, Multiple myeloma, Oncology, Product Pipeline, Progression-Free Survival (PFS), Protease inhibitors, R&D, R&DTakeda Pharmaceutical opened a new 24,000-square-foot R&D cell therapy manufacturing facility in Boston at the site of the company’s R&D headquarters.
Takeda Pharmaceutical released data from the Phase III TOURMALINE-MM2 clinical trial of adding Ninlaro (ixazomib) to lenalidomide and dexamethasone compared to lenalidomide and dexamethasone plus placebo in treating newly diagnosed multiple myeloma (MM) patients who were not eligible for autologous stem cell transplant.