All Oncology News

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.

Dostarlimab Plus Chemotherapy Meets ORR End Point in Metastatic Nonsquamous NSCLC

October 5th 2022

The 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.

$1.8 Million NIH Grant Supports Head and Neck Cancer Research

October 5th 2022

Sylvester Comprehensive Cancer Center researchers Lluis Morey, PhD, and Ramiro Verdun, PhD, have received a $1.8 million NIH R01 grant to study the epigenetic mechanisms that drive head and neck cancers.

FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab in Frontline NSCLC

October 5th 2022

The 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 2022

Advances 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 2022

Oral 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 2022

The 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 2022

The 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 Green Lights Companion Diagnostic for Trastuzumab Deruxtecan in Metastatic HER2-Low Breast Cancer

October 4th 2022

The FDA has approved use of the PATHWAY anti-HER2/neu rabbit monoclonal primary antibody as a companion diagnostic to identify patients with HER2-low metastatic breast cancer who are eligible for treatment with trastuzumab deruxtecan.

FDA Approval Sought for Denileukin Diftitox for Persistent or Recurrent Cutaneous T-cell Lymphoma

October 4th 2022

A 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 2022

The 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 2022

The 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.

Dana-Farber Joins Parker Institute for Cancer Immunotherapy to Accelerate Cures for the World’s Gravest Cancers

October 4th 2022

Dana-Farber Cancer Institute, one of the world’s leading cancer research and treatment centers, has partnered with the Parker Institute for Cancer Immunotherapy, the leading network of immuno-oncology expertise in the world, as a member of the PICI Network with a goal to better understand the tumor microenvironment across cancer types and translate these basic discoveries to the clinic as impactful cancer immunotherapies.

Zanubrutinib Provides ORR, PFS Benefits Over Ibrutinib in Relapsed/Refractory CLL/SLL

October 4th 2022

Zanubrutinib 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 2022

Treatment 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.

GPRC5D Antigen–Targeted CAR T-cell Therapy Induces Strong Response in Resistant Multiple Myeloma

October 3rd 2022

MCARH109, a CAR T-cell therapy targeting the “enigmatic” GPRC5D antigen, generated remissions in 70.6% of patients with relapsed/refractory multiple myeloma.

Loncastuximab Tesirine/Rituximab Elicits Promising Anti-Tumor Activity in Relapsed/Refractory DLBCL

October 3rd 2022

Loncastuximab tesirine-lpyl combined with rituximab demonstrated encouraging antitumor activity and a feasible safety profile in patients with relapsed/refractory diffuse large B-cell lymphoma.

Momelotinib Improves OS in Patients With Myelofibrosis and Low Platelet Counts

October 3rd 2022

Momelotinib induced superior 24-week overall survival rates compared with danazol in thrombocytopenic, symptomatic, and anemic patients with myelofibrosis.

CAR T-Cell Therapy Proves Effective in First Trial in Patients with Resistant Multiple Myeloma

October 3rd 2022

Study 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 2022

Single-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.

Pan-FGFR Inhibitor Seeks to Overcome Resistance Hurdles in Cholangiocarcinoma and Urothelial Carcinoma

October 3rd 2022

Early sensitivity to FGFR inhibition has improved outcomes for patients across tumor histologies; however, kinase domain mutations limit extended efficacy for select patients including those with intrahepatic cholangiocarcinoma or urothelial cancer.