The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Surufatinib/Toripalimab Combo Elicits Encouraging Efficacy in Advanced Neuroendocrine Carcinoma
November 13th 2021The combination of surufatinib and toripalimab demonstrated promising clinical activity with a manageable safety profile when used as second-line treatment for patients with advanced neuroendocrine carcinoma.
Eftilagimod Alpha/Paclitaxel Combo Shows Improved OS in Metastatic HR+ Breast Cancer Subsets
November 12th 2021The combination of eftilagimod alpha and paclitaxel produced a modest increase in median overall survival in patients with endocrine-resistant hormone receptor–positive/HER2-negative metastatic breast cancer. Though, the effects were significant in patients younger than 65 years old, had low monocytes, or had more aggressive disease.
PD-L1/4-1BB–Directed Bispecific Antibody ATG-101 Shows Preclinical Efficacy Without Hepatotoxicity
November 12th 2021ATG-101, a novel PD-L1/4-1BB bispecific antibody, demonstrated good in vivo efficacy, safety without hepatotoxicity, and pharmacokinetic/pharmacodynamic properties in cynomolgus monkeys.
DuoBody®-CD3x5T4 Induces Efficient T-cell Activation, Tumor Cell Killing in HNSCC Cell Lines
November 12th 2021The DuoBody®-CD3x5T4 was found to induce secretion of granzyme B and efficiently kill tumor cells in co-cultures of healthy donor T cells and patient-derived head and neck squamous cell carcinoma cell lines.
Sotorasib Approaches EU Approval for KRAS G12C–Mutated Advanced NSCLC
November 12th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.
Surufatinib Induces Robust Responses in US Patients with Extrapancreatic and Pancreatic NETs
November 12th 2021Surufatinib demonstrated strong antitumor activity along with a manageable safety profile in heavily treated US patients with progressive extrapancreatic neuroendocrine tumors or pancreatic NETs, according to interim phase 1 data.
Pre-BLA Meeting Held With FDA for Omidubicel in Select High-Risk Hematologic Malignancies
November 12th 2021Gamida Cell Ltd. has completed a Type B Pre-Biologics License Application meeting with the FDA to discuss the investigational advanced cell therapy omidubicel as a potential therapeutic option for patients with blood cancers who require stem cell transplant.
Investigators Set Their Sights on Optimizing Sequencing With Novel Therapies in GU Cancers
November 12th 2021Treatment selection and sequencing in genitourinary cancers, such as metastatic bladder cancer and metastatic renal cell carcinoma, have become more complicated and require nuanced decision making.
Trilaciclib Possesses Potential to Reduce Burden of Chemotherapy-Induced Myelosuppression in ES-SCLC
November 11th 2021The administration of trilaciclib prior to chemotherapy reduced chemotherapy-induced myelosuppression and the need for associated supportive care in patients with extensive-stage small cell lung cancer.
Up-front Surgery, Biologics Do Not Improve Survival in Resectable CRC With Liver Metastases
November 11th 2021Chemotherapy has demonstrated mixed findings in patients with resectable colorectal hepatic metastases, and long-term data suggest incorporating it into treatment algorithms have little impact on overall survival.
Experts Talk Through Exciting T-Cell Therapies in Multiple Myeloma
November 11th 2021Although BCMA-directed CAR T-cell therapy has shown early and deep responses in patients with relapsed/refractory multiple myeloma, there is much more to learn about optimal cytokine release syndrome and neurotoxicity management and treatment sequencing, particularly as off-the-shelf T-cell therapies, bispecific antibodies, and non–BCMA-directed therapies become available.
First-in-class Anti-CD47 Fusion Protein DSP107 Under Investigation in AML and MDS
November 10th 2021The FDA cleared an investigational new drug application for a phase 1b clinical trial examining DSP107, a first-in-class anti-CD47 fusion protein, in patients with acute myeloid leukemia and myelodysplastic syndrome.
Ripretinib Continues to Provide Meaningful Clinical Benefit in Heavily Pretreated GIST
November 10th 2021John R. Zalcberg, MBBS, PhD, discusses the INVICTUS trial examining ripretinib in patients with heavily pretreated gastrointestinal stromal tumors, the impact of the agent on the paradigm, and ongoing efforts to provide additional options to this population.
FDA Clears IND to Expand ABILITY Trial Examining MDNA11 in Solid Tumors to the United States
November 9th 2021The FDA has greenlit an investigation new drug application to expand the ongoing phase 1/2 ABILITY trial, which is evaluating the beta-only IL-2 superagonist MDNA11 in patients with solid tumors, to clinical trial sites in the United States.