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.

Unresolved Issues in Antineoplastic Drug Therapy: Is It Finally Time to Address?

August 14th 2023

Several articles featured in a recent issue of the highly respected publication the Medical Letter on Drugs and Therapeutics highlight themes across drug development that are relevant within the broad antineoplastic arena. The topics range from appropriate control arms in randomized clinical trials to sponsorship of trials to the rationale for developing novel agents when suitable, cost-effective biosimilar and generic products are available.

GVAX Cancer Vaccine Plus Nivolumab and Urelumab Elicits Early Efficacy in Pancreatic Adenocarcinoma

August 14th 2023

Treatment with the GVAX pancreatic cancer vaccine plus nivolumab and urelumab increased the presence of intratumoral activated cytotoxic T cells and showed early signs of efficacy in patients with resectable pancreatic adenocarcinoma.

IBI322 Shows Early Antitumor Efficacy in PD-1/PD-L1–Resistant Classical Hodgkin Lymphoma

August 13th 2023

Single-agent IBI322 elicited responses with favorable safety in patients with classical Hodgkin lymphoma that had become resistant to anti–PD-1/PD-L1 therapy, according to data from a phase 1 trial.

Extended Treatment With CAEL-101 Plus SOC Therapy Proves Safe in Light-Chain Amyloidosis

August 12th 2023

The addition of the chimeric monoclonal antibody CAEL-101 to standard therapy with cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab demonstrated a manageable toxicity profile with prolonged clinical benefit in patients with amyloid light-chain amyloidosis.

FDA Approves Niraparib Plus Abiraterone Acetate for BRCA+ mCRPC

August 11th 2023

The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.

Cancer Vaccine IFx-Hu2.0 Confers Immune Priming Effect in Previously Treated MCC and CSCC

August 11th 2023

The novel personalized cancer vaccine IFx-Hu2.0 was found to be safe and well tolerated with weekly dosing in patients with checkpoint inhibitor–resistant cutaneous squamous cell carcinoma and Merkel cell carcinoma, according to data from an ongoing phase 1b trial.

Teclistamab Plus Nirogacestat Elicits Durable Responses in Relapsed/Refractory Myeloma

August 11th 2023

The combination of teclistamab and nirogacestat produced high and deep responses in patients with relapsed/refractory multiple myeloma.

Early Efficacy of BL-B01D1 in a Phase 1 Study Reflects Potential for ADCs in Lung Cancer and Beyond

August 11th 2023

Helena A. Yu, MD, discusses the investigation of BL-B01D1 in patients with advanced solid tumors, the potential significance of this research for those with EGFR-mutant and wild-type disease, and the expanding body of evidence supporting continued antibody-drug conjugate development in non–small cell lung cancer.

Tirabrutinib Generates Sustained Efficacy in Relapsed/Refractory PCNSL

August 11th 2023

Treatment with the second-generation BTK inhibitor tirabrutinib continued to elicit durable responses in patients with relapsed/refractory primary central nervous system lymphoma, according to findings from the final 3-year analysis of a phase 1/2 trial.

Ofranergene Obadenovec Plus Paclitaxel Misses the Mark in Platinum-Resistant Ovarian Cancer

August 11th 2023

The addition of ofranergene obadenovec to paclitaxel failed to significantly improve survival outcomes compared with paclitaxel alone in patients with platinum-resistant ovarian cancer.

FCS Co-authored Study Confirms Effectiveness of Trilaciclib for Treatment of Patients with Extensive-Stage Small Cell Lung Cancer

August 11th 2023

Florida Cancer Specialists & Research Institute, LLC, physicians and senior leaders are co-authors of a study that confirms the effectiveness of trilaciclib for the treatment of adult patients with extensive-stage small cell lung cancer.

FDA Allows Continuation of Phase 1/2 Trial of ONCT-534 in mCRPC

August 11th 2023

The FDA has approved a study may proceed letter in advance of its 30-day review period to Oncternal Therapeutics for its phase 1/2 study evaluating ONCT-534, a novel dual-action AR inhibitor in patients with mCRPC who have relapsed or are refractory to approved AR signaling inhibitors.

BDC-1001 Monotherapy Under Further Evaluation in Phase 2 Trial in HER2+ Cancers

August 11th 2023

The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.

ORCHID Trial of Olaparib Monotherapy Could Lay Groundwork for Investigating PARP Inhibitors in Advanced RCC

August 11th 2023

Yasser Mohamed Ali Ged, MBBS, highlights the early efficacy seen in patients with renal cell carcinoma with BAP1 mutations and next steps for the ORCHID trial.

Evaluation of Novel Agents and Combinations Aims to Improve Outcomes in Frontline RCC

August 10th 2023

Ulka Nitin Vaishampayan, MBBS, discusses factors to consider for choosing between immuno-oncology/immuno-oncology and VEGF TKI/immuno-oncology combinations for the frontline treatment of patients with renal cell carcinoma, areas of ongoing research in this disease, and treatment updates across the prostate cancer spectrum.

SAMETA Trial Evaluates Efficacy of Savolitinib Plus Durvalumab in MET-Driven Papillary RCC

August 10th 2023

The safety and efficacy achieved with the combination of savolitinib and durvalumab vs standard-of-care sunitinib or durvalumab monotherapy will be evaluated in patients with MET-driven papillary renal cell carcinoma in the phase 3 SAMETA trial.

Linvoseltamab Produces Durable Responses in Relapsed/Refractory Multiple Myeloma

August 10th 2023

Hans Lee, MD, discusses unmet needs in patients with relapsed/refractory multiple myeloma, highlights key efficacy and safety findings from the LINKER-MM1 trial, and how these data may inform the future of the multiple myeloma treatment paradigm.

Huntsman Cancer Institute Research Highlights For July 2023

August 10th 2023

This month, researchers reduce the risk of infections after pancreatic surgery and discover the best cost-effective treatment combination for prostate cancer patients.

Glecirasib Receives Breakthrough Therapy Designation in China for KRAS G12C–Mutated Pancreatic Cancer

August 10th 2023

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

Lasofoxifene/Abemaciclib Combination Aims to Fill Need in ESR1-Mutant, ER+/HER2- Breast Cancer

August 10th 2023

Finding effective treatments beyond the first line for patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer and an ESR1 mutation remains a challenge following development of resistance to agents.