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.
FDA Approves Adjuvant Olaparib for BRCA+, High-Risk Early Breast Cancer
March 11th 2022The FDA has approved olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have previously received chemotherapy either before or after surgery.
Sugemalimab Shows Efficacy as Consolidation Therapy in Unresectable Stage III NSCLC
March 11th 2022Sugemalimab significantly prolonged progression-free survival (PFS) vs placebo in Chinese patients with locally advanced, unresectable, stage III non–small cell lung cancer who did not progress after concurrent or sequential chemoradiotherapy.
Sintilimab/Anlotinib Produces Meaningful Responses in PD-L1+ Recurrent or Metastatic Cervical Cancer
March 11th 2022The addition of anlotinib to sintilimab appeared to be efficacious and safe when used as a second- or later-line treatment in patients with PD-L1–positive, recurrent or metastatic cervical cancer.
Biomarkers of Response Steer Treatment Selection in Breast Cancer
March 11th 2022Tiffany Traina, MD, discusses the body of evidence supporting the use of CDK4/6 inhibitors in hormone receptor–positive, HER2-negative breast cancer, shifting standards of care in HER2-positive disease, as well as biomarkers of response with checkpoint inhibitors and PARP inhibitors in triple-negative breast cancer.
Evolving Technology Behind ADCs Could Improve Benefit in Advanced Ovarian Cancer
March 11th 2022Michael Birrer, MD, PhD, discusses how new technology has transformed ADCs, how upifitamab rilsodotin could have a role in treating patients with ovarian cancer, and why the NaPi2B biomarker could be a vital target.
Phase 1/2 FELIX Trial to Determine Obe-Cel Potential in Adult Patients With ALL
March 10th 2022Claire Roddie, MD, PhD, discusses how the phase 1/2 FELIX trial could impact the treatment landscape for acute lymphoblastic leukemia, how CAR T-cell therapies have evolved, and what challenges remain in making these treatments more accessible for patients.
Precision Genomics Moves Toward Increased Granularity in Molecular Sequencing
March 10th 2022Kelvin P. Lee, MD, discusses the nuances of an effective molecular tumor board, explains the practical application of precision oncology genomics, and highlights the pathways that have the potential to change the treatment landscape for precision oncology.
European Approval Sought for Ivosidenib in IDH1-Mutated AML and Cholangiocarcinoma
March 10th 2022A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.
NEJM Data Underscore OS Benefit With Ribociclib/Letrozole in HR+ Advanced Breast Cancer
March 10th 2022The combination of ribociclib and letrozole resulted in a statistically significant improvement in overall survival vs letrozole alone in patients with postmenopausal, hormone receptor–positive, HER2-negative advanced breast cancer, with this benefit continuing to increase over time, supporting the use of this combination as a frontline treatment in this population.
Investigators Look to Enhance Outcomes for Unresectable ESCC With Chemoradiation Combination
March 10th 2022Since most diagnoses of esophageal squamous cell carcinoma are made when the disease is in advanced stages, investigators have initiated studies to evaluate the efficacy of immunotherapy in earlier lines of therapy, including in combination with chemoradiotherapy.
Analysis of Genomic Alterations in Metastases Could Help Inform Treatment in RCC
March 10th 2022Rana R. McKay, MD, discusses findings from a real-world study on genomic alterations of metastases in renal cell carcinoma, the rationale of the phase 3 COSMIC-313 trial in patients with previously untreated advanced or metastatic RCC, plus findings from the phase 1/2 COMRADE trial in patients with metastatic castration-resistant prostate cancer.
NICE Rejects Pembrolizumab Plus Chemotherapy for Select Metastatic TNBC
March 9th 2022The United Kingdom’s National Institute for Health and Clinical Excellence has issued draft guidance recommending against pembrolizumab plus chemotherapy as a treatment for patients with metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score of 10 or more and who have not received chemotherapy for metastatic disease.
Folding CAR T-cell Therapy Into Relapsed/Refractory MCL Treatment
March 9th 2022Treatment with the CD19-directed CAR T-cell therapy brexucabtagene autoleucel demonstrated significant activity, marked by high response rates and prolonged survival, in patients with relapsed mantle cell lymphoma in the pivotal ZUMA-2 trial.
Increasing Treatment Pathways Pave the Way for Heartening Future Throughout Hematologic Malignancies
March 9th 2022Stephen Oh, MD, PhD, discusses current and emerging agents in myelofibrosis, advances in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, updates in acute and chronic graft-vs-host-disease, and chronic lymphocytic leukemia management.
Phase 3 NuTide:121 Study Examining NUC-1031 in Biliary Tract Cancer to be Discontinued
March 8th 2022The phase 3 NuTide:121 trial examining the first-in-class nucleotide analogue NUC-1031 in combination with cisplatin vs gemcitabine plus cisplatin in patients with advanced biliary tract cancer is being discontinued.
Higher Doses of Ibrutinib/Venetoclax Not Linked With Higher Responses in Relapsed/Refractory MCL
March 8th 2022The combination of ibrutinib given at 420 mg and venetoclax at 200 mg elicited an objective response rate of 93.8% in patients with relapsed/refractory mantle cell lymphoma, according to results of a phase 1 dose-finding study.