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.

Maintenance Pembrolizumab/Olaparib Misses Survival End Points in Locally Advanced or Metastatic TNBC

December 6th 2023

Pembrolizumab plus olaparib did not improve progression-free or overall survival vs pembrolizumab plus chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer who received induction pembrolizumab plus chemotherapy.

BDC-1001 Plus Pertuzumab Is Under Exploration in HER2+ Breast Cancer

December 6th 2023

The phase 2 BBI-20231001 trial evaluating the Boltbody immune-stimulating antibody conjugate BDC-1001 with or without pertuzumab in patients with HER2-positive breast adenocarcinoma is open for enrollment in the United States, France, Italy, and Spain.

Neoadjuvant Pembrolizumab Plus Chemo Improves pCR Across Key ER+ Breast Cancer Subgroups

December 6th 2023

The addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy improved pathologic complete responses in key subsets of patients with early-stage, high-risk, estrogen receptor–positive/HER2-negative breast cancer enrolled in the phase 3 KEYNOTE-756 trial.

Persistent ctDNA Correlates With Disease Recurrence in HR+/HER2– Early Breast Cancer

December 6th 2023

Detection of circulating tumor DNA with the Signatera assay was associated with disease recurrence in patients with hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer at 24 months post-randomization to treatment with adjuvant abemaciclib and endocrine therapy.

Capivasertib Maintains QOL Benefit Vs Placebo in HR+/HER2– Advanced Breast Cancer

December 6th 2023

Capivasertib plus fulvestrant did not negatively affect quality of life compared with placebo plus fulvestrant in patients with aromatase inhibitor–resistant, hormone receptor–positive, HER2-negative advanced breast cancer.

AI Assistance Proves Safe, Decreases Time and Cost Burden of Sentinel Lymph Node Detection in Metastatic Breast Cancer

December 6th 2023

Utilizing an artificial intelligence–assisted workflow to detect sentinel lymph node metastases in patients with breast cancer was deemed safe according to current diagnostic standards and reduced the need for immunohistochemistry and its associated financial burden.

Ribociclib Plus Endocrine Therapy Improves PFS and OS in Elderly Patients With HR+/HER2– Breast Cancer

December 6th 2023

The combination of ribociclib and endocrine therapy led to an improvement in progression-free survival and overall survival vs placebo plus endocrine therapy in patients with hormone receptor-positive/HER2-negative advanced breast cancer across all age groups.

Dana-Farber Researchers to Present Findings at 2023 San Antonio Breast Cancer Symposium

December 6th 2023

Researchers from Dana-Farber Cancer Institute will present more than 30 research studies at the 46th annual San Antonio Breast Cancer Symposium, December 5–9, 2023.

FDA Approves Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

December 6th 2023

The FDA has approved iptacopan (Fabhalta) for use in adult patients with paroxysmal nocturnal hemoglobinuria.

FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer

December 5th 2023

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.

FDA Grants Priority Review to Frontline Nivolumab Plus Chemo for Unresectable or Metastatic Urothelial Carcinoma

December 5th 2023

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

Westin Testifies to Senate Finance Committee on Cancer Drug Shortage

December 5th 2023

Shortages of several anticancer drugs continue to negatively impact clinicians’ ability to deliver the best possible care to patients.

AEGEAN Subgroup Analysis Fails to Demonstrate Clear Benefit With Perioperative Durvalumab Plus Chemo in EGFR+ NSCLC

December 5th 2023

David Harpole, MD, discusses key data from the first interim analysis of the AEGEAN trial, changes to the adjuvant treatment landscape that inspired the subgroup analysis of patients with EGFR mutations excluded from the intention-to-treat population, and more.

Florida Cancer Specialist Optimizing Use of Anticancer Drugs to Improve Care for Patients with Blood Disorders

December 5th 2023

A best practice clinical program developed by Florida Cancer Specialists & Research Institute, LLC is ensuring that patients with certain blood disorders achieve maximum clinical benefits from the use of oral medications.

FDA Grants Breakthrough Device Designation to Assay for ACR-368 in Ovarian Cancer

December 5th 2023

The FDA granted breakthrough device designation to the ACR-368 OncoSignature assay for the identification of patients with ovarian cancer who may derive benefit from the CHK1/2 inhibitor ACR-368.

New Developments in MPN Management Provide Additional Options for Patients

December 5th 2023

Significant progress has been made in terms of understanding myeloproliferative neoplasms and developing treatment strategies to combat them.

Frontline Serplulimab Plus Chemo Provides Consistent Survival Benefit in Squamous NSCLC

December 5th 2023

The addition of serplulimab to carboplatin and nab-paclitaxel significantly prolonged survival vs chemotherapy alone when used in the first-line treatment of patients with previously untreated locally advanced or metastatic squamous non–small cell lung cancer.

FDA Grants Orphan Drug Designation to LP-284 for High-Grade B-Cell Lymphomas

December 4th 2023

The FDA has granted orphan drug designation to LP-284 for use in the treatment of patients with high-grade B-cell lymphoma harboring MYC and BCL2 rearrangements.

BDTX-1535 Strives to Overcome Intrinsic and Acquired EGFR Mutations in NSCLC and GBM

December 4th 2023

Patients with non–small cell lung cancer harboring acquired EGFR mutations, such as C797S and intrinsic mutations in EGFR represent underserved populations where additional targeted therapies are needed.

FDA Grants Fast Track Designation to BI 764532 for DLL3+ Large-Cell NEC of the Lung

December 4th 2023

The FDA has granted a fast track designation to BI 764532 for use as a therapeutic option in patients with advanced or metastatic DLL3-expressing large-cell neuroendocrine carcinoma of the lung who experienced disease progression after treatment with 1 or more lines of therapy, including platinum-based chemotherapy.