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.

Phase 3 KEYLYNK-008 Trial of Pembrolizumab Plus Olaparib in Metastatic Squamous NSCLC to Stop for Futility

December 8th 2023

The phase 3 KEYLYNK-008 trial evaluating pembrolizumab plus olaparib in patients with metastatic squamous non–small cell lung cancer will be discontinued for futility, according to an announcement from Merck.

Trastuzumab Deruxtecan Plus Endocrine Therapy Demonstrates Antitumor Activity in HER2-Low/HR+ Metastatic Breast Cancer

December 7th 2023

Anastrozole or fulvestrant plus fam-trastuzumab deruxtecan-nxki demonstrated encouraging antitumor activity in patients with chemotherapy-naïve, HER2-low hormone receptor–positive metastatic breast cancer.

T-DXd Yields Early Activity in HER2+/HER2-Low Breast Cancer With Leptomeningeal Carcinomatosis

December 7th 2023

Treatment with trastuzumab deruxtecan generated clinical responses in patients with HER2-low or HER2-positive advanced breast cancer with pathologically confirmed leptomeningeal carcinomatosis.

Datopotamab Deruxtecan Prolongs PFS in HR+/HER2- Inoperable or Metastatic Breast Cancer

December 7th 2023

Datopotamab deruxtecan resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy among patients with previously treated, hormone receptor-positive/HER2-negative inoperable or metastatic breast cancer.

Inavolisib Plus Palbociclib and Fulvestrant Improves PFS in PIK3CA-Mutated HR+ Breast Cancer

December 7th 2023

The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.

T-DXd Demonstrates Real-World Efficacy in Advanced Breast Cancer With Dynamic HER2 Expression

December 7th 2023

Administration of fam-trastuzumab deruxtecan significantly prolonged time-to-next treatment in patients with HER2-positive or HER2-low metastatic breast cancer, including patients who experienced changes in HER2 status during the treatment course.

Nivolumab Plus Ipilimumab Improves PFS in Newly Diagnosed Metastatic Colorectal Cancer

December 7th 2023

The combination of nivolumab and ipilimumab led to a statistically significant and clinically meaningful improvement in progression-free survival per blinded independent central review compared with investigator’s choice of chemotherapy as frontline therapy in patients with metastatic colorectal cancer.

Icahn School of Medicine at Mount Sinai Secures $5 Million NIH Grant for Cutting-Edge Cancer Target Discovery and Development Center

December 7th 2023

The Department of Immunology and Immunotherapy and the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai have been awarded a $5 million grant from the National Cancer Institute of the National Institutes of Health to establish a state-of-the-art center dedicated to the discovery and development of cutting-edge targets for cancer therapy.

Tovorafenib Induces Responses in Low-Grade Gliomas, Including Optic Pathway Gliomas

December 7th 2023

Tovorafenib elicited rapid, clinically meaningful tumor responses in pediatric patients with low-grade gliomas, including those with optic pathway gliomas, regardless of prior MAPK inhibitor status.

Disparities in Survival Outcomes Revealed With BluePrint and MammaPrint Subtyping in HR+/HER2– Breast Cancer

December 7th 2023

Precise stratification of hormone receptor–positive, HER2-negative breast cancer using BluePrint and MammaPrint assays revealed comparable 3-year recurrence-free survival rates between Black and White patients despite observed racial differences in the distribution of molecular subtypes.

PFS Benefit Observed With Tucatinib Plus T-DM1 in Previously Treated HER2+ Metastatic Breast Cancer

December 6th 2023

The addition of tucatinib to ado-trastuzumab emtansine (T-DM1) significantly improved progression-free survival vs placebo plus T-DM1 in patients with previously treated HER2-positive metastatic breast cancer, including those with brain metastases.

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.