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.
Pembrolizumab/Lenvatinib Combo Misses OS End Points in Select Advanced Melanoma and mCRC
April 7th 2023The phase 3 LEAP-003 and LEAP-017 trials evaluating pembrolizumab plus lenvatinib did not meet their primary end points of overall survival in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer, respectively.
NICE Guidance Supports Olaparib Use in BRCA-Mutant Breast, Prostate Cancer
April 7th 2023The National Institute for Health and Care Excellence announced final draft guidance recommending the PARP inhibitor olaparib for patients with HER2-negative, high-risk early breast cancer harboring a BRCA1/2 mutation, as well as for those with previously treated hormone-relapsed metastatic prostate cancer with a BRCA1/2 mutation.
AbbVie Withdraws Ibrutinib MCL and MZL Indications in the United States
April 7th 2023AbbVie has announced the intention to voluntarily withdraw indications for ibrutinib in patients with mantle cell lymphoma who have previously received at least 1 therapy and in those with marginal zone lymphoma who require systemic treatment and have received at least 1 prior anti–CD20-based therapy.
Two-Pronged Immunotherapy Eliminates Metastatic Breast Cancer in Mice
April 7th 2023Researchers at Washington University School of Medicine in St. Louis have identified a way to treat the area surrounding breast tumors that have spread to bone so that such tumors become vulnerable to attack by the body’s immune system.
Effective Detection of MRD May Support Earlier Implementation of ctDNA Testing in CRC
April 6th 2023Stacey A. Cohen, MD, discusses the advantages and limitations of ctDNA as a biomarker for detecting minimal residual disease , real-world data on the relationship between fluctuating cfDNA levels and ctDNA detection, and how implementing ctDNA testing earlier to identify minimal residual disease could serve as a prognostic tool in clinical practice.
Recent Approvals Support Continued Research on New and Emerging ADCs Across Breast Cancer Subtypes
April 6th 2023Stephanie L. Graff, MD, gives an overview of recently approved ADCs in TNBC and HR-positive, HER2-negative breast cancer, as well as the importance of continued research with these agents in the first-line setting.
Rapid Advances Shake Up Treatment Considerations in ALL, CML, AML
April 6th 2023Elias Jabbour, MD; Harry Paul Erba, MD, PhD; Anjali Advani, MD; and Sameem Abedin, MD, discuss key updates pertaining to the leukemia treatment landscape that were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition.
Second-Line Liposomal Irinotecan Fails to Improve OS, PFS Over Topotecan in SCLC
April 6th 2023Single-agent liposomal irinotecan resulted in a similar median overall survival and progression-free survival to that achieved with topotecan in patients with small cell lung cancer that had progressed on or following frontline platinum-based chemotherapy.
Venetoclax Induces Notable ORR But Short PFS in High-Risk Mantle Cell Lymphoma
April 5th 2023Venetoclax, alone or in combination with a BTK inhibitor, improved overall response rate in patients with pretreated, high-risk mantle cell lymphoma, according to findings from a retrospective study. However, the BCL-2 inhibitor was associated with short durations of progression-free survival.
Novel CDK9 Inhibitor Under Investigation in Solid Tumors and NHL
April 5th 2023Miguel Villalona-Calero, MD, discusses the unique mechanism of action of KB-0742 and the rationale and design of a phase 1 trial investigating the safety and efficacy of KB-0742 in patients with relapsed/refractory solid tumors or non-Hodgkin lymphoma.
Sox9 Protein Enables Molecular Time Travel That Can Lead to Colorectal Cancer
April 5th 2023Research from Dana-Farber Cancer Institute looks at what happens before the emergence of mutations that interrupt cellular differentiation in colorectal cancer and finds not only evidence of fetal reprogramming that can initiate cancer, but also a protein, Sox9, that fuels that reprogramming.
FDA Accepts BLA for Trastuzumab Biosimilar in HER2+ Breast Cancer, Gastric/GEJ Cancer
April 5th 2023The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
Not All Stage I and II Endometrial Cancers Are Alike
April 5th 2023A recent retrospective study found that patients with endometrial cancer in International FICO stage I high- intermediate risk subgroups with fewer than 2 risk factors had a greater than 95% cause-specific survival at 3-year follow-up, and subgroups with 2 or more risk factors had poorer outcomes.
Investigators Turn a Focused Eye to Targeting Weaknesses in BPDCN
April 5th 2023Because of the disease’s rarity relative to other hematologic malignancies and challenges arriving at an accurate diagnosis, patients with blastic plasmacytoid dendritic cell neoplasm have historically encountered a dearth of effective treatment options.
Atezolizumab Following Neoadjuvant Atezolizumab and Resection Improves DFS in NSCLC
April 4th 2023Data for adjuvant atezolizumab following neoadjuvant atezolizumab and resection demonstrated an improvement in disease-free survival and a trend toward improved overall survival in patients with resectable stage IB to IIIB non–small cell lung cancer compared with those who did not receive adjuvant atezolizumab.
TAVO-EP Plus Pembrolizumab Fails to Meet ORR End Point in Anti–PD-1–Refractory Advanced Melanoma
April 4th 2023The combination of the interleukin-12 encoding plasmid TAVO™-EP plus pembrolizumab did not meet the prespecified primary end point for overall response rate in patients with advanced melanoma that was refractory to anti–PD-1 therapy.
FDA Accepts sNDAs for Encorafenib and Binimetinib in BRAF V600E–Mutant NSCLC
April 4th 2023The FDA has accepted for review supplemental new drug applications for the combination of encorafenib and binimetinib for the treatment of patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.