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.
Durvalumab, Tremelimumab, and Chemotherapy Elicit Promising Long-Term OS Rates in NSCLC
October 6th 2022Melissa L. Johnson, MD, expands on the updated data from the POSEIDEN trial, the rationale for investigating the combination, and what these results mean for the treatment of metastatic non–small cell lung cancer.
Investigators Lay Groundwork for Exploring TROP-2 as a Therapeutic Target in NSCLC
October 6th 2022Clinicians looking for additional options for the treatment of patients with non–small cell lung cancer may soon be gaining another actionable biomarker with the emergence of exciting new data concerning targeting the cell-surface glycoprotein TROP-2.
CUE-101 Gets Fast Tracked for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
October 5th 2022The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab in patients with human papillomavirus recurrent or metastatic head and neck squamous cell carcinoma.
Dostarlimab Plus Chemotherapy Meets ORR End Point in Metastatic Nonsquamous NSCLC
October 5th 2022The addition of dostarlimab to chemotherapy led to an improvement in objective response rate vs pembrolizumab plus chemotherapy in patients with newly diagnosed metastatic nonsquamous non–small cell lung cancer.
FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab in Frontline NSCLC
October 5th 2022The FDA has granted a fast track designation to eftilagimod alpha for use in combination with pembrolizumab as a frontline treatment for patients with stage IIIB/IV non–small cell lung cancer.
Novel AR-Targeted Therapies for Metastatic Hormone-Sensitive Prostate Cancer: Which One to Choose
October 5th 2022Advances in the understanding of the genomics and biological functions of prostate cancer have resulted in the emergence of several new classes of agents that have improved outcomes in men with prostate cancer, including metastatic hormone-sensitive prostate cancer.
ASTX727/Venetoclax Combo Is Safe and Effective in First-Line and Relapsed/Refractory AML
October 5th 2022Oral decitabine plus cedazuridine added to oral venetoclax demonstrated promising overall response rates in patients with acute myeloid leukemia who received the combination as a first-line treatment or after relapsing on prior therapies.
PDS0101 Plus Pembrolizumab Under Further Evaluation in HPV16+ HNSCC
October 4th 2022The FDA has agreed on key elements of the clinical program to support the biologic license application for the combination of PDS0101 and pembrolizumab for the treatment of unresectable, recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma.
Sapanisertib Gets FDA Fast Track Status for Pretreated NRF2-Mutated Squamous NSCLC
October 4th 2022The FDA has granted a fast track designation to sapanisertib as a potential therapeutic option in patients with unresected or metastatic squamous non–small cell lung cancer whose tumors harbor an NRF2 mutation and who have previously received platinum-based chemotherapy and immune checkpoint inhibition.
FDA Approval Sought for Denileukin Diftitox for Persistent or Recurrent Cutaneous T-cell Lymphoma
October 4th 2022A biologics license application seeking the approval of a reformulation of denileukin diftitox for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma has been submitted to the FDA.
SCO-101 Plus FOLFIRI Will Continue to Be Studied Despite Missing Primary End Point in mCRC
October 4th 2022The addition of SCO-101 to FOLFIRI chemotherapy was safe and tolerable but failed to elicit a greater than 30% reduction in tumor volume in patients with metastatic colorectal cancer, though study of the combination will continue.
Talazoparib/Enzalutamide Combo Meets rPFS End Point in Untreated Metastatic CRPC
October 4th 2022The addition of talazoparib to enzalutamide produced a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs enzalutamide plus placebo in previously untreated patients with metastatic castration-resistant prostate cancer, with or without homologous recombination repair gene mutations.
Zanubrutinib Provides ORR, PFS Benefits Over Ibrutinib in Relapsed/Refractory CLL/SLL
October 4th 2022Zanubrutinib elicited significantly higher response rates and survival benefits compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma .
Pacritinib Improves Transfusion Independence, Anemia Through ACVR1 Inhibition in Myelofibrosis
October 3rd 2022Treatment with pacritinib led to an improvement in transfusion independence and hemoglobin in patients with myelofibrosis according to findings from a retrospective analysis of the phase 3 PERSIST-2 trial.
Loncastuximab Tesirine/Rituximab Elicits Promising Anti-Tumor Activity in Relapsed/Refractory DLBCL
October 3rd 2022Loncastuximab tesirine-lpyl combined with rituximab demonstrated encouraging antitumor activity and a feasible safety profile in patients with relapsed/refractory diffuse large B-cell lymphoma.
CAR T-Cell Therapy Proves Effective in First Trial in Patients with Resistant Multiple Myeloma
October 3rd 2022Study establishes rationale for combination approaches targeting multiple proteins — therapy produces responses in 70% of study participants, including those who who relapsed after prior CAR T therapy.
Rucaparib Meets rPFS End Point in BRCA/ATM-Mutated mCRPC
October 3rd 2022Single-agent rucaparib significantly improved radiographic progression-free survival vs chemotherapy or second-line androgen deprivation therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer harboring BRCA or ATM mutations.