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.
Thrombocytopenia Is Associated With High Levels of Fatigue in Myelofibrosis
December 20th 2022Jeanne M. Palmer, MD, discusses a retrospective analysis of the PERSIST-1 and PAC203 trials, the symptoms that were analyzed across patient populations, and what the findings from this research indicate about the relationship between low platelet counts and symptoms such as fatigue in myelofibrosis.
Durvalumab Misses OS End Point in PEARL Trial in Advanced, PD-L1–High NSCLC
December 19th 2022Durvalumab monotherapy failed to elicit a statistically significant improvement in overall survival vs platinum-based chemotherapy as frontline treatment in patients with stage IV non–small cell lung cancer with at least 25% positivity of PD-L1 on tumor cells, or in a subgroup of patients at low risk of early mortality.
UK Accepts Marketing Authorization Application for Sugemalimab in Metastatic NSCLC
December 19th 2022The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer.
Fox Chase Graduate Student Billy Truong Recognized With ASH Abstract Achievement Award
December 19th 2022Billy Truong, a doctoral candidate at Fox Chase Cancer Center, was awarded the American Society of Hematology Abstract Achievement Award for a poster that he presented at the 64th ASH Annual Meeting and Exposition.
European Commission Approves Trastuzumab Deruxtecan in Pretreated HER2+ Advanced Gastric/GEJ Cancer
December 19th 2022The European Commission has approved fam-trastuzumab deruxtecan-nxki as monotherapy for the treatment of patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
European Commission Recommends Trastuzumab Deruxtecan for HER2-Low Metastatic Breast Cancer
December 19th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval for the use of trastuzumab deruxtecan monotherapy for adults with unresectable or metastatic HER2-low breast cancer.
Anti-CEACAM5 ADC Could Represent the Next Targeted Therapy in Advanced Nonsquamous NSCLC
December 19th 2022Alexander Spira, MD, PhD, FACP, discusses the rationale for targeting CEACAM5 in NSCLC, how tusamitamab ravtansine could provide encouraging frontline responses in the CEACAM5-positive, nonsquamous population, and enrollment challenges faced by ongoing clinical trials.
Chemoimmunotherapy Regimens Improve Long-term Outcomes in Small Cell Lung Cancer
December 18th 2022Stephen V. Liu, MD, discusses the effect of the FDA approval of atezolizumab on the development of other chemoimmunotherapy regimens and ongoing efforts to expand and individualize treatment options in small cell lung cancer.
Sacituzumab Govitecan, Trastuzumab Deruxtecan Highlight Expanding Role of ADCs in TNBC
December 17th 2022Nour Abuhadra, MD, discusses what the data from DESTINY-Breast04 means for trastuzumab deruxtecan in the triple-negative breast cancer space and future areas of research for antibody-drug conjugates in this disease.
FDA Approves Nadofaragene Firadenovec for High-risk Non–Muscle Invasive Bladder Cancer
December 16th 2022The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
Frontline Zolbetuximab Plus CAPOX Meets PFS, OS End Points in Claudin 18.2+ Gastric or GEJ Cancers
December 16th 2022The addition of zolbetuximab to capecitabine and oxaliplatin resulted in a statistically significant improvement in progression-free survival and overall survival vs placebo/CAPOX in patients with Claudin 18.2–positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal cancers, meeting the primary and secondary end points of the phase 3 GLOW trial.
Individualized Maintenance Niraparib Dosing Confers Favorable OS in Recurrent Ovarian Cancer
December 16th 2022The use of an individualized starting dose of niraparib led to a trend toward improved overall survival as maintenance therapy vs placebo in Chinese patients with platinum-sensitive, recurrent ovarian cancer regardless of germline BRCA mutation status, according to data from the phase 3 NORA trial.
How to Improve Care for LGBTQI+ Patients With Cancer
December 16th 2022As more and more people in the United States identify as lesbian, gay, bisexual, transgender, queer, intersex, or other sexual orientation or gender minority, the population of LGBTQI+ cancer survivors is becoming uniquely heterogeneous.
Advancements in Immunotherapy Expand and Improve the Treatment Landscape for MCL
December 16th 2022Joshua Brody, MD, discussed significant updates in MCL treatment presented at the 2022 ASH Annual Meeting, including results from the phase 1/2 BRUIN trial of pirtobrutinib, follow-up data from the phase 2 ZUMA-7 trial on CAR T-cell therapies, and next steps to expand the development of immunotherapies in this disease.
Biomarker Testing Informs Individualized Diagnosis and Treatment of Low- to Intermediate-Risk AML
December 16th 2022Alexander E. Perl, MD, MS, discusses the implications of the updated ELN guidelines, how genetic testing guides treatment in this disease, and ongoing research investigating novel AML targets such as NPM1 mutations or KMT2A translocations.
PD-L1 Status Could Help Inform Patient Selection for IO-Based Therapy in HNSCC
December 15th 2022Ranee Mehra, MD, discusses the significance of 5-year follow-up data and the subgroup analysis from KEYNOTE-048, the benefits and limitations of IO therapy in head and neck squamous cell carcinoma, and research aiming to expand the role of IO combination regimens in this space.
FDA Delays PDUFA Hearing for Olaparib/Abiraterone Combo in mCRPC
December 15th 2022The FDA has told AstraZeneca and MSD that the agency will extend the Prescription Drug User Fee Act date by 3 months to provide further time for a full review of the supplementary new drug application for olaparib plus abiraterone and prednisone or prednisolone for patients with mCRPC.
Trastuzumab Deruxtecan sNDA for HER2-Mutant Metastatic NSCLC Submitted for Review in Japan
December 15th 2022Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.
Novel Targeted Immunotherapies Strengthen Frontline Treatment Strategies in Hodgkin Lymphoma
December 15th 2022Joshua Brody, MD, discusses unmet needs in patient subgroups within Hodgkin lymphoma, recent advancements in the use of antibody-drug conjugates such as brentuximab vedotin and anti–PD-1 therapies in earlier lines of therapy, and future avenues for expanding the use of immunotherapy in this tumor type.