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.

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.

Fox Chase Cancer Center Welcomes Dr. Christopher G. Cann

August 23rd 2023

Fox Chase Cancer Center is pleased to announce the hiring of Christopher G. Cann, MD, as an assistant professor in the Department of Hematology/Oncology with a focus on gastrointestinal cancers.

FDA Grants Priority Review to Enzalutamide for nmCSPC With High-Risk Biochemical Recurrence

August 23rd 2023

The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.

Tiragolumab Plus Atezolizumab Falls Short in Unexpected OS Analysis in PD-L1–High NSCLC

August 23rd 2023

The addition of the investigational anti-TIGIT immunotherapy tiragolumab to atezolizumab demonstrated a numerical but not statistically significant improvement in overall survival vs atezolizumab alone as frontline therapy for patients with PD-L1–high, locally advanced or metastatic non–small cell lung cancer.

PROSPECT Trial Confirms Feasibility of De-escalation of Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer

August 23rd 2023

Michael Cecchini, MD, expands on key updates in gastrointestinal cancer from the 2023 ASCO Annual Meeting, including the clinical significance of findings from the PROSPECT and phase 3 PRODIGE 23 trials of perioperative chemotherapy vs selective standard chemoradiation.

Neoadjuvant Dendritic Cell Vaccine–Based Regimen Elicits pCRs in Early-Stage HER2+ Breast Cancer

August 23rd 2023

A neoadjuvant treatment regimen consisting of HER2-directed conventional dendritic cell intratumoral therapy plus paclitaxel, trastuzumab, and pertuzumab elicited pathologic complete responses in patients with stage I to III HER2-positive breast cancer.

Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma

August 22nd 2023

The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.

HER2 Amplification Shows Prognostic Capabilities in mCRC

August 22nd 2023

HER2 amplification appears to be prognostic in patients with RAS wild-type metastatic colorectal cancer but may not be predictive of survival benefit as a first-line treatment option in combination with panitumumab vs standard-of-care bevacizumab.

Novel ADCs Must Keep Up With Moving Targets in Metastatic Breast Cancer

August 22nd 2023

Barbara Pistilli, MD, discusses the mechanism of action of novel ADCs, the ways in which ADC targets in breast cancer can change over time, and how future research may pave the way for individualized treatment with this class of agents.