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.
ASTRO/ESTRO Release Clinical Guideline for Local Therapy in Oligometastatic NSCLC
April 26th 2023The American Society for Radiation Oncology and European Society for Radiotherapy & Oncology have released the first clinical guideline on the use of definitive local therapy, including radiation and surgery, for the treatment of patients with oligometastatic non–small cell lung cancer.
Furmonertinib Plus Icotinib Elicits Antitumor Activity in EGFR+ NSCLC With CNS Metastases
April 26th 2023First-line treatment with furmonertinib plus icotinib induced responses in patients with EGFR-mutant non–small cell lung cancer. including those with central nervous system metastases, according to data from an ongoing phase 2 trial.
Iptacopan Meets Primary End Point of APPOINT-PNH Trial in Paroxysmal Nocturnal Hemoglobinuria
April 26th 2023Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.
FIDES-02 Data Fail to Support the Development of Derazantinib in Metastatic Urothelial Cancer
April 25th 2023Andrea Necchi, MD, discusses the efficacy and safety data reported from the FIDES-02 study, explains the clinical relevance of these data despite the trial’s negative result, and highlights several other influential studies presented at the 2023 Genitourinary Cancers Symposium.
AZD3759 Elicits Responses in Untreated EGFR-Mutant NSCLC With CNS Metastases
April 25th 2023AZD3759 elicited clinical responses and had an acceptable toxicity profile when administered at a dose of 200 mg twice daily in patients with untreated EGFR-mutant non–small cell lung cancer and central nervous system metastases, according to data from the phase 2 TRUMP trial.
TRAVERSE Study Shows Preliminary Efficacy and Safety of ALLO-316 in Advanced Clear Cell RCC
April 25th 2023Samer A. Srour, MB ChB, MS, explains the unique construction of ALLO-316, the potential for ALLO-316 to address an unmet need in patients with clear cell renal cell carcinoma, and how early data from the TRAVERSE study support the continued investigation of ALLO-316 in patients with CD70-expressing tumors.
Durvalumab Plus Chemo Is Tolerable in Real-World Representative ES-SCLC Population
April 25th 2023First-line durvalumab plus up to 6 cycles of platinum and etoposide is safe and tolerable with signals of clinical efficacy consistent with those previously seen in patients with treatment-naïve extensive-stage small cell lung cancer.
FDA Places Partial Clinical Hold on Trial of FHD-609 in Synovial Sarcoma and SMARCB1-Deleted Tumors
April 24th 2023The FDA has placed a partial clinical hold on the phase 1 trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of FHD-609 in patients with advanced synovial sarcoma and SMARCB1-deleted tumors.
Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC
April 24th 2023The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.
Subgroup Analysis Shows Consistent Benefit for Dostarlimab Plus Chemo in Nonsquamous NSCLC
April 24th 2023Overall response rates were similar across subgroups of patients with nonsquamous non–small cell lung cancer for the combinations of dostarlimab-gxly plus chemotherapy and pembrolizumab plus chemotherapy, and responses numerically favored the dostarlimab-based combination in most subgroups, according to a subgroup analysis of the phase 2 PERLA trial.
Sugemalimab Monotherapy Has Clinical Benefit in NK/T-Cell Lymphoma
April 24th 2023The PD-L1 inhibitor sugemalimab produced durable responses with a tolerable safety profile in patients with relapsed/refractory natural killer/T-cell lymphoma, according to findings from a preplanned primary analysis of the multicenter, single-arm, phase 2 GEMSTONE-201 trial.
Ribociclib Plus Letrozole Has Activity in Recurrent Low-Grade Serous Ovarian Cancer
April 24th 2023Brian M. Slomovitz, MD, discusses key efficacy and safety data seen with ribociclib and letrozole in the GOG 3026 trial and planned efforts to identify associated biomarkers and pursue FDA approval for the combination in advanced, recurrent low-grade serous ovarian cancer.
Tucatinib/Trastuzumab Approval Highlights Expansion of Tailored Therapies in HER2+ CRC
April 21st 2023John L. Hays, MD, PhD, discusses the importance of tailoring therapies for patients with CRC who express HER2 or have other actionable targets, the need to develop optimal sequences for local and systemic therapy in CRC, and key updates in hepatocellular carcinoma and pancreatic cancer.
Selinexor/Ruxolitinib Combo Elicits Sustained Spleen Responses, Improves Symptoms in Myelofibrosis
April 21st 2023The combination of selinexor at 60 mg and ruxolitinib induced rapid and durable spleen responses and improved symptoms at weeks 12 and 24 in patients with treatment-naïve myelofibrosis, according to updated data from the phase 1 XPORT-MF-034 trial.
Tislelizumab Plus Chemotherapy Meets OS End Point in Advanced Gastric/GEJ Adenocarcinoma
April 21st 2023The combination of tislelizumab plus chemotherapy elicited a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy plus placebo in patients with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
O’Shaughnessy Showcases Highlights in Breast Cancer Guiding 2023 IBC Congresses
April 21st 2023Joyce A. O’Shaughnessy, MD, highlights multidisciplinary approaches including discussions on tumor boards, and discusses how to better assist patients with accessing care, and notable advances in the field particularly with the HER2 classification.
FDA Extends Review for Quizartinib in Newly Diagnosed FLT3-ITD+ AML
April 21st 2023The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.