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 2023Pembrolizumab 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 2023The 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 2023The 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 2023Detection 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 2023Capivasertib 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.
FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer
December 5th 2023The 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.
Frontline Serplulimab Plus Chemo Provides Consistent Survival Benefit in Squamous NSCLC
December 5th 2023The 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.
BDTX-1535 Strives to Overcome Intrinsic and Acquired EGFR Mutations in NSCLC and GBM
December 4th 2023Patients 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 2023The 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.
ADC Doublets Represent a Promising Novel Approach for Treatment-Resistant mUC
December 4th 2023Bradley A. McGregor, MD, expands on the feasibility and safety considerations addressed through the design and methodology of the DAD study; highlights dose-limiting toxicities and early responses seen with sacituzumab govitecan plus enfortumab vedotin in treatment-resistant mUC; and explains how these results support further investigation of other ADC doublets.
TKI and Immunotherapy Combo Efforts in RCC Remain of Interest as Treatment Arsenal Evolves
December 4th 2023Final outcomes from the phase 1b/2 Study 111/KEYNOTE-146 trial, evaluating treatment with lenvatinib and pembrolizumab in patients with advanced renal cell carcinoma, has sparked interest in the use of this combination.
Ovarian Cancer Research Outlines the Role of ADCs, PARP Inhibitors, and Surgery
December 4th 2023Hope Cottrill, MD, highlights key points that were presented at a State of the Science Summit meeting, including the role of bevacizumab plus PARP inhibitors in ovarian cancer management, how to manage adverse events associated with antibody-drug conjugates, and ongoing research in ovarian cancer risk reduction.
Neoadjuvant Chemotherapy Does Not Give Survival Benefit Over Chemoradiation in Cervical Cancer
December 3rd 2023Neoadjuvant chemotherapy preceding surgery did not result in a significant difference in 5-year overall survival rates compared with concomitant chemoradiotherapy in patients with stage IB2 to IIB cervical carcinoma, according to findings from the phase 3 EORTC-55994 trial.
Adding Pemetrexed to Cisplatin Does Not Result in Survival Benefit Over Vinorelbine in NSCLC
December 2nd 2023Adjuvant treatment with the chemotherapy doublet of pemetrexed and cisplatin did not lead to a significant improvement in overall survival compared with vinorelbine plus cisplatin in patients with stage II to IIIA nonsquamous non–small cell lung cancer.
FDA Approves Pirtobrutinib for Previously Treated CLL/SLL
December 1st 2023The FDA has granted an accelerated approval to pirtobrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
Enfortumab Vedotin/Pembrolizumab Extends PFS and OS in Metastatic Urothelial Cancer
December 1st 2023Thomas Powles, MD, MBBS, MRCP, discusses key background information about the EV-302 trial; the efficacy and safety findings from this trial; and the future implications of the data from several emerging trials in urothelial cancer.