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.
CCR4 Antagonists May Bolster Immune Responses With Checkpoint Inhibitors in PD-L1+ NSCLC
November 16th 2023The addition of tivumecirnon to pembrolizumab was safe, well-tolerated, and clinically active vs the historical activity of pembrolizumab monotherapy in patients with checkpoint inhibitor–naive non–small cell lung cancer.
New Data From 2023 ESMO Congress Further Define the Evolving Role of ADCs in NSCLC
November 15th 2023With a plethora of data coming out of the 2023 European Society for Medical Oncology Congress, findings from multiple clinical trials examining antibody-drug conjugates in non–small cell lung cancer demonstrated encouraging antitumor activity and manageable safety profiles, including results from the phase 3 TROPION-Lung01 study, which evaluated datopotamab deruxtecan vs docetaxel in pretreated patients with advanced or metastatic disease.
Regulatory Decisions and Research Boost Management Strategies for Hematologic Malignancies
November 15th 2023Andrew Kuykendall, MD, discusses the current role of JAK inhibitors in myelofibrosis, the importance of chronic graft-vs-host disease awareness in patients with myeloid malignancies receiving transplant, and unmet needs for patients with chronic myelomonocytic leukemia.
Pembrolizumab Plus Enzalutamide/ADT Fails to Improve rPFS in mHSPC
November 15th 2023The addition of pembrolizumab (Keytruda) to enzalutamide (Xtandi) and androgen deprivation therapy did not improve radiographic progression-free survival vs placebo plus enzalutamide and ADT in patients with metastatic hormone-sensitive prostate cancer, according to data from the phase 3 KEYNOTE-991 trial presented at the 2023 ESMO Congress.
Durvalumab Plus Chemo Wins Approval in China For Advanced/Metastatic Biliary Tract Cancer
November 14th 2023China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.
Adding Immunotherapy to Chemotherapy Regimen Improves Survival in Metastatic Bladder Cancer Patients
November 14th 2023A clinical trial co-led by Mount Sinai researchers is the first to show that using chemotherapy with immunotherapy resulted in improved survival in patients with an advanced type of bladder cancer.
CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications
November 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer
Momelotinib Approaches EU Approval for Myelofibrosis With Anemia
November 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.
CHMP Recommends Adagrasib for Pretreated KRAS G12C+ Advanced NSCLC
November 14th 2023After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.
Bayer Withdraws US Indication for Copanlisib in Relapsed Follicular Lymphoma
November 13th 2023Bayer has announced the intention to voluntarily withdraw the new drug application for copanlisib in adult patients with relapsed follicular lymphoma who have previously received at least 2 prior systemic treatments.
Oncology Researchers Raise Ethics Concerns Posed By Patient-Facing Artificial Intelligence
November 13th 2023In a new paper in JCO Oncology Practice, bioethics researchers at Dana-Farber Cancer Institute call on medical societies, government leaders, clinicians, and researchers to work together to ensure AI-driven healthcare preserves patient autonomy and respects human dignity.
NCCN Endorses Goserelin in Salivary Gland Tumors in New Head and Neck Cancers Guidelines
November 13th 2023TerSera Therapeutics LLC announced that The National Comprehensive Cancer Network Head and Neck Cancers Panel recommended the GnRH agonist goserelin for patients with recurrent, unresectable, or metastatic salivary gland tumors who were not eligible for surgery or radiation therapy.
Learning the Language of Cells to Beat Cancer
November 12th 2023Andrew L. Ji, MD, is working to better understand cutaneous squamous cell carcinoma —a skin cancer that is the second most common cancer in the United States and one that causes substantial morbidity, with a considerable risk for metastatic spread and death.
Early Use of ctDNA May Accelerate Time to Treatment and Improve Survival in NSCLC
November 11th 2023While there are considerable barriers to incorporating comprehensive genotyping, the use of circulating tumor DNA offers an improvement in molecular testing—and doing so earlier can accelerate the time to treatment and improve survival for patients with lung cancer.
IO Combos Yield OS Advantage Vs Chemo Alone in Stage IV PD-L1–Negative NSCLC
November 11th 2023As treatments for patients with stage IV non–small cell lung cancer continue to evolve, patients with PD-L1–negative disease represent a unique cohort and chemotherapy/immunotherapy or immunotherapy doublet regimens appear to be effective.