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 Status to ALE.C04 for Recurrent or Metastatic CLDN1+ HNSCC

August 25th 2023

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.

VEGF and HIF Pathway Inhibition Point Toward an Increasingly Tolerable RCC Armamentarium

August 25th 2023

Qian (Janie) Qin, MD, discusses the current RCC treatment landscape, ongoing research with belzutifan combination therapies, and considerations for investigating CAR T-cell therapy in patients with solid tumors.

Fox Chase Researcher Receives Grant for Study of RNA, Telomerase and Implications for Disease

August 25th 2023

A Fox Chase Cancer Center researcher has been awarded a $2.5 million grant from the National Institute of General Medical Sciences to investigate RNA structure and stability, work that has implications for cancer, Alzheimer’s, and other degenerative diseases and continues the Fox Chase legacy of basic research.

FDA Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC

August 25th 2023

A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.

LEAP-010 Trial Discontinued After OS Projection With Pembrolizumab/Lenvatinib in Metastatic HNSCC

August 25th 2023

The combination of pembrolizumab and lenvatinib demonstrated a statistically significant improvement in progression-free survival and objective response rate but failed to improve overall survival compared with pembrolizumab plus placebo as frontline therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Dara-KRd Quadruplet Makes Waves in Newly Diagnosed Multiple Myeloma

August 25th 2023

Luciano J. Costa, MD, PhD, discussed extended follow-up data from the trial and explained how the results may affect frontline treatment decisions in multiple myeloma.

Case Studies Illustrate the Importance of Nuanced Treatment Discussions in Advanced RCC

August 25th 2023

Hans Hammers, MD, PhD, outlines 3 cases of patients with renal cell carcinoma, detailing how each patient’s disease presented and how clinicians proceeded with treatment.

Cabozantinib Efficacy Prompts CABINET Trial Unblinding in Advanced Pancreatic and Extra-Pancreatic NETs

August 24th 2023

Interim data from the phase 3 CABINET trial demonstrated significant improvement in progression-free survival with cabozantinib vs placebo in patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors following progression on prior systemic therapy.

Sovleplenib Elicits Durable Responses in Primary Immune Thrombocytopenia

August 24th 2023

Sovleplenib provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia in China.

Novel Bispecific ADC Generates Early Efficacy Signals in Lung and Head and Neck Cancers

August 24th 2023

Pasi A. Jänne, MD, PhD, discusses the advantages of bispecific ADCs that target both HER3 and EGFR; preliminary efficacy and safety data seen with BL-B01D1 in patients with non–small cell lung cancer; and the activity of this agent in patients with head and neck squamous cell carcinoma, small cell lung cancer, and nasopharynx cancer.

Ponatinib Plus Low-Dose Chemotherapy Improves MRD– CR Rates in Newly Diagnosed Ph+ ALL

August 24th 2023

Elias Jabbour, MD, outlines additional findings from PhALLCON and their clinical implications for patients with Philadelphia chromosome-positive ALL

REGAL Trial Examining Galinpepimut-S in AML to Continue Without Modifications

August 24th 2023

An independent data monitoring committee has recommended that the phase 3 REGAL trial evaluating galinpepimut-S in patients with acute myeloid leukemia should continue without modifications.

Researcher Leads NCI Grant to Develop Urine Test for Noninvasive Detection of Prostate Cancer

August 24th 2023

Sanoj Punnen, MD, the University of Miami Miller School of Medicine, is leading a $2.5 million, five-year National Cancer Institute grant to explore a new way to noninvasively detect prostate cancer.

Olaparib Plus Abiraterone Acetate Receives Japanese Approval for BRCA-Mutant mCRPC

August 24th 2023

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated castration-resistant prostate cancer with distant metastasis.

Addition of Doxorubicin to Zalifrelimab/Balstilimab Leads to Responses in Advanced Soft Tissue Sarcoma

August 24th 2023

Breelyn Wilky, MD, discusses the rationale for investigating the addition of doxorubicin to zalifrelimab and balstilimab in patients with advanced/metastatic soft tissue sarcoma, expands on results from the phase 2 trial, and emphasizes the need for continued research for the potential role of immunotherapy in this patient population.

TROP2 Expression Predicts Sacituzumab Govitecan Activity in Recurrent Endometrial Cancer

August 24th 2023

Alessandro Santin, MD, discusses the rationale and design of a phase 2 trial of sacituzumab govitecan in patients with persistent or recurrent endometrial cancer; unmet needs for patients with this disease; and key findings from the stage 1 portion of the trial.

Sunvozertinib Approved in China for NSCLC With EGFR Exon 20 Insertion Mutations

August 23rd 2023

The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.

Erdafitinib Elicits Responses in FGFR-altered Solid Tumors

August 23rd 2023

Treatment with erdafitinib resulted in clinical benefit for patients with advanced solid tumors harboring susceptible FGFR alterations who had exhausted all other treatment options, meeting the primary end point of overall response rate of the phase 2 RAGNAR trial.

FDA Awards Orphan Drug Designation to NXC-201 for Multiple Myeloma

August 23rd 2023

The FDA has granted orphan drug designation to NXC-201 for use as a potential therapeutic option in patients with multiple myeloma.

Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC

August 23rd 2023

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.