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.

FDA Grants Fast Track Designation to Zotatifin Plus Fulvestrant/Abemaciclib in ER+/HER2– Breast Cancer

November 30th 2023

The FDA has granted fast track designation to zotatifin for use in combination with fulvestrant and abemaciclib as second- or third-line therapy for the treatment of patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK4/6 inhibitor.

Dolphins Challenge Cancer and AutoNation Team Up to Tackle Breast Cancer Disparities

November 30th 2023

Dolphins Challenge Cancer and AutoNation are teaming up to address the links between social, economic and environmental factors and breast cancer mortality.

B7-H4–Directed ADCs May Broaden Breast and Gynecologic Cancer Armamentariums

November 30th 2023

Bradley J. Monk, MD, FACOG, FACS, and Paolo Tarantino, MD, discuss key data with B7-H4–directed antibody-drug conjugates across solid tumor types, the evolving role of antibody-drug conjugates in gynecologic cancers, and the importance of determining optimal sequencing with these agents in breast cancer.

ADC Choices Require Discretion in HER2-Negative MBC

November 30th 2023

With multiple antibody drug conjugate options now available for patients with HER2-negative metastatic breast cancer, clinicians must consider a variety of factors when selecting and sequencing therapies.

FDA Grants Clearance for Phase 1/2 Trial of eTIL KSQ-001EX in Solid Tumors

November 30th 2023

The FDA has granted clearance for an investigational new drug application for a phase 1/2 safety lead-in trial investigating the engineered tumor-infiltrating lymphocyte KSQ-001EX in patients with melanoma, head and neck squamous cell carcinoma, and non–small cell lung cancer.

Nadofaragene Firadenovec Induces Durable Activity in High-Risk, BCG-Unresponsive NMIBC With CIS

November 29th 2023

Nadofaragene firadenovec-vncg led to encouraging rates of high-grade recurrence-free survival and overall survival in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Long-Term Survival Benefit With PD-1 Monotherapy Correlated With High PD-L1 Expression in Advanced NSCLC

November 29th 2023

Biagio Ricciuti, MD, discusses the need to improve the identification of patients with advanced non–small cell lung cancer that benefit most from immune checkpoint inhibition.

Perioperative Enfortumab Vedotin Shows Antitumor Activity in Cisplatin-Ineligible MIBC

November 29th 2023

Perioperative enfortumab vedotin elicited responses in cisplatin-eligible patients with muscle-invasive bladder cancer.

Florida Cancer Specialists & Research Institute Announces Bradley Monk, MD as Medical Director of Late-Phase Clinical Research Program

November 29th 2023

Florida Cancer Specialists & Research Institute, LLC is pleased to announce that Bradley Monk, MD will join the statewide practice as Medical Director of Late-Phase Research, effective January 1, 2024.

Telisotuzumab Vedotin Meets Clinical End Points in LUMINOSITY Trial in Previously Treated NSCLC

November 29th 2023

Telisotuzumab vedotin produced meaningful response rates and other clinically relevant outcomes in patients with c-Met protein overexpressed, EGFR wild-type, advanced or metastatic nonsquamous non–small cell lung cancer.

Expansion of First-Line Treatment Options in Unresectable HCC Requires Consideration of High-Risk Disease Features

November 29th 2023

Reena J. Salgia, MD, discusses the advantages of utilizing an atezolizumab plus bevacizumab backbone as standard frontline therapy in unresectable HCC; how factors such as Child-Pugh B score, bleeding, and other high-risk features impact treatment selection; and the unmet needs that still need to be addressed for this patient population.

Camrelizumab Plus Famitinib Shows Promise in Recurrent or Metastatic Cervical Cancer

November 29th 2023

The combination comprised of camrelizumab and famitinib showcased improved efficacy with a manageable safety profile vs camrelizumab monotherapy or investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer.

IBI351 NDA Under NMPA Review in Advanced KRAS G12C–Mutant NSCLC

November 28th 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted and granted priority review to the new drug application for IBI351 in the treatment of patients with advanced, KRAS G12C–mutant NSCLC who have received at least 1 prior systemic therapy.

Nimotuzumab With Concurrent Chemoradiotherapy Shows Activity in Cervical Squamous Cell Carcinoma

November 28th 2023

Nimotuzumab given concurrently with chemoradiotherapy demonstrated efficacy and favorable tolerability in patients with locally advanced cervical squamous cell carcinoma, according to data from a randomized, controlled, open-label, multicenter study.

Retifanlimab Continues to Elicit Responses in Recurrent MSI-H or dMMR Endometrial Cancer

November 28th 2023

Retifanlimab-dlwr continued to elicit responses with acceptable tolerability in patients with recurrent microsatellite instability–high or mismatch–repair deficient endometrial cancer, according to final findings from cohort H of the phase 1 POD1UM-101 trial.

Emerging TROP-2 Directed ADCs Show Promise in Advanced NSCLC

November 28th 2023

Benjamin Philip Levy, MD, discusses the current landscape of emerging antibody-drug conjugates (ADCs) and their early activity in advanced lung cancer, the potential utility of oncogene-directed ADCs for patients with driver mutations, and more.

EG12014 Gets Go Ahead in EU for HER2+ Breast and Metastatic Gastric Cancers

November 28th 2023

EG12014, a biosimilar of the anti-HER2 monoclonal antibody trastuzumab, has received a marketing authorization from the European Commission for use in the European Union for the treatment of patients with HER2-positive breast and metastatic gastric cancer; these are the same indications that trastuzumab holds in the EU.

Cleveland Clinic Research Reveals How Breast Cancer Gene Mutations May Impact Cell Communication

November 28th 2023

New Cleveland Clinic research reveals how BRCA1 and BRCA2 gene mutations may impact cell communication in breast tissue, furthering the understanding of how cancer develops.

Cadonilimab Plus Chemo With or Without Bevacizumab Improves PFS in Recurrent or Metastatic Cervical Cancer

November 28th 2023

The frontline combination of cadonilimab and platinum-based chemotherapy with or without bevacizumab provided a progression-free survival benefit in patients with recurrent or metastatic cervical cancer.

Hematologists Dive into the Current Treatment Landscape

November 28th 2023

Ehab L. Atallah, MD, highlights updates in chronic lymphocytic leukemia, emphasizing the importance of understanding the plethora of options that are present for oncologists treating patients within this population.