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.

Adjuvant Pembrolizumab Improves OS in Select Patients With RCC After Nephrectomy

November 1st 2023

Adjuvant treatment with pembrolizumab significantly improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions, meeting a key secondary end point of the phase 3 KEYNOTE-564 trial.

Fox Chase Cancer Center Invests in Expanding Access to Lifesaving Radiopharmaceuticals for Cancer Patients

November 1st 2023

As the first initiative of an emerging collaboration, Fox Chase Cancer Center has invested in Nucleus RadioPharma, a company specializing in the development and distribution of radiopharmaceuticals, targeted therapies that deliver radiation directly to cancer cells.

AON Goes Public, Aims to Leverage Increased Resources Into Improved Patient Care

November 1st 2023

On September 20, 2023, with the goal of improving care, the American Oncology Network announced the completion of its business combination with Digital Transformation Opportunities Corp to become a publicly traded entity.

FDA Approves Pembrolizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

November 1st 2023

The FDA has approved pembrolizumab (Keytruda) plus gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Sacituzumab Govitecan Plus Enfortumab Vedotin Shows Early Promise in Metastatic Urothelial Carcinoma

October 31st 2023

Combining sacituzumab govitecan-hziy and enfortumab vedotin-ejfv was safe, feasible, and produced high and early response rates in patients with treatment-resistant metastatic urothelial cancer.

Novel B7-H4 Targeted ADCs Generate Activity and Show Manageable Safety Profile in Breast and Other Cancers

October 31st 2023

Two novel antibody-drug conjugates, HS-20089 and SGN-B7H4V, targeting the highly expressed immune checkpoint ligand B7-H4 have demonstrated manageable safety profiles and shown anti-tumor activity in first-in-human dose-escalation portions of phase 1 trials and will move forward to the next portions of the studies.

FDA Grants Fast Track Designation to SLS009 for Relapsed/Refractory PTCL

October 31st 2023

The FDA has granted a fast track designation to SLS009 for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

FDA Lifts Clinical Hold on Phase 1 Trial Evaluating XMT-2056 in HER2-Expressing Solid Tumors

October 31st 2023

The FDA has lifted the clinical hold placed on a phase 1 trial evaluating XMT-2056 monotherapy in patients with HER2-high or -low advanced or recurrent solid tumors.

VAL-083 Fails to Outperform SOC in Glioblastoma

October 31st 2023

VAL-083 did not improve efficacy compared with standard-of-care approaches in patients with glioblastoma.

FDA Grants Breakthrough Therapy Designation to Furmonertinib for EGFR Exon 20 Insertion+ NSCLC

October 31st 2023

The FDA has granted breakthrough therapy designation to furmonertinib for use as a potential therapeutic option in patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer harboring EGFR exon 20 insertion mutations.

Dr Igor Astsaturov Appointed Inaugural Holder of Paul F. Engstrom Professorship in Oncology at Fox Chase Cancer Center

October 31st 2023

Igor Astsaturov, MD, PhD, has been appointed inaugural holder of the Paul F. Engstrom Professorship in Oncology.

Providing Timely Cancer Care Access Is Crucial Amid Growing Patient Volume

October 31st 2023

A closer look at some of the approaches being used across The US Oncology Network to improve patient access can provide helpful insight into how practices can meet the growing need for their services.

Emerging Therapeutic Targets Shape Testing and Treatment Decisions in SCLC and NSCLC

October 31st 2023

Apar Kishor Ganti, MD, discusses molecular targets to test for in lung cancer; treatment approaches for small cell lung cancer; and immunotherapy options for patients with metastatic non–small cell lung cancer in the frontline setting and beyond.

EMA Validates Application for Frontline Nivolumab Plus Chemo in Advanced Urothelial Cancer

October 30th 2023

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

Dostarlimab Plus Chemo Provides OS Benefit in Primary Advanced or Recurrent Endometrial Cancer

October 30th 2023

The addition of dostarlimab to carboplatin plus paclitaxel followed by dostarlimab monotherapy significantly improved overall survival compared with placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

Vimseltinib Improves 25-Week ORR Vs Placebo in TGCT

October 30th 2023

Vimseltinib elicited a statistically significant and clinically meaningful improvement in 25-week overall response rate vs placebo in patients with tenosynovial giant cell tumor that was not amenable to surgery.

Indirect Treatment Comparison Indicates Improved OS With Brexu-Cel in BTK Inhibitor–Exposed R/R MCL

October 30th 2023

Brexucabtagene autoleucel demonstrated an improvement in overall survival vs standard of care therapy in patients with relapsed/refractory mantle cell lymphoma following prior exposure to a BTK inhibitor, according to data from an indirect treatment comparison of findings from the phase 2 ZUMA-2 trial and retrospective SCHOLAR-2 trial.

Dr Stephen D. Nimer Named Researcher of the Year

October 30th 2023

BioFlorida, a statewide association for Florida’s life sciences industry, has named Stephen D. Nimer, MD, director of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, “Researcher of the Year.”

FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma

October 30th 2023

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

Postoperative ctDNA Status May Prognosticate DFS Outcomes in Resected CRC

October 30th 2023

Postoperative circulating tumor DNA (ctDNA)–based minimal residual disease status demonstrated prognostic value for patients with stage I to IV resected colorectal cancer, showing that those with positive ctDNA after surgery have significantly lower disease-free survival outcomes at 24 months vs those who were ctDNA negative.