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.
Vopratelimab/JTX-4014 to be Evaluated in Phase 2 Study for Immunotherapy-Naïve NSCLC
December 17th 2020December 17, 2020 - Jounce Therapeutics will evaluate its lead agent vopratelimab in combination with the anti–PD-1 monoclonal antibody JTX-4014, in patients with non-small cell lung cancer who have not received immunotherapy.
Liso-Cel Proves to Be Highly Active, Tolerable in Relapsed/Refractory MCL
December 17th 2020December 17, 2020 - Lisocabtagene maraleucel exhibited promising antitumor activity with low rates of grade 3 or higher cytokine release syndrome and neurotoxicity in patients with relapsed/refractory mantle cell lymphoma.
Overcoming CDK4/6 Inhibitor Resistance in ESR1-Mutant HR+/HER2- Breast Cancer
December 17th 2020Massimo Cristofanilli, MD, highlights the introduction of CDK4/6 inhibitors, such as abemaciclib, ribociclib, and palbociclib, which has been a significant addition to the hormone receptor–positive, HER2-negative breast cancer armamentarium.
AR Inhibitors Lead to Higher Fall/Fracture Risk in Older Men With Prostate Cancer
December 17th 2020December 17, 2020 - Androgen receptor inhibitor–therapy is associated with an increased risk of falls and fractures in patients with prostate cancer. However, since it has shown improvement in overall survival, the benefits may outweigh the risk.
KTE-X19 Approved in Europe for Relapsed/Refractory MCL
December 17th 2020December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.
FDA Approval Sought for Sotorasib for KRAS G12C–Mutated Advanced or Metastatic NSCLC
December 17th 2020December 16, 2020 - A new drug application has been submitted to the FDA for sotorasib for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, after at least 1 previous systemic therapy.
FDA Approves Margetuximab-cmkb Plus Chemo in Pretreated Metastatic HER2+ Breast Cancer
December 16th 2020December 16, 2020 - The FDA has approved margetuximab-cmkb plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.
Second-Line Motixafortide Plus Pembrolizumab/Chemo Substantially Improves Survival in Stage IV PDAC
December 16th 2020December 16, 2020 - The combination of motixafortide plus pembrolizumab and chemotherapy was found to result in a substantial improvement in overall survival, progression-free survival, and overall response rate when used as a second-line treatment in patients with stage IV pancreatic ductal adenocarcinoma.
Giant of Cancer Care® Eric Winer Elected ASCO President for 2022-2023 Term
December 16th 2020December 16, 2020 - Eric P. Winer, MD, FASCO, 2019 OncLive Giants of Cancer Care® recipient in Breast Cancer, has been elected to serve as the president of ASCO for the 2022-2023 term, and will assume the president-elect position during the 2020 ASCO Annual Meeting.
Janku Highlights PFS Benefit With Dose-Escalated Ripretinib in Advanced GIST
December 15th 2020Filip Janku, MD, PhD highlighted a dose-escalated approach of ripretinib and how it yielded a progression-free survival benefit in patients with gastrointestinal stromal tumor across all lines of treatment in a phase 1 study.
Trastuzumab Deruxtecan Approaches EU Approval for HER2+ Metastatic Breast Cancer
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2–based regimens.
Fixed-Dose Durvalumab Nears EU Approval for Unresectable NSCLC
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.
TNBC Treatment Paradigm Advances With the Rise of Chemoimmunotherapy Combos
December 15th 2020Neelima Vidula, MD, highlights some of the pivotal trials evaluating immunotherapy combination regimens in triple-negative breast cancer, some of the challenges faced in practice, and areas for further exploration.
Overcoming Clinical Challenges Associated With TP53-Mutant MDS, AML
December 15th 2020TP53-mutant myelodysplastic syndromes and acute myeloid leukemia represent a molecularly distinct, poor-risk patient subgroup frequently associated with complex karyotypes, high propensity for relapse, and inferior overall survival.
Halmos Zeroes in on Year Ahead for Lung Cancer Treatment
December 15th 2020Balazs Halmos, MD discusses the year 2021 and how it will encompass a bigger focus on neoadjuvant and adjuvant trials, more novel molecular compounds for more select subgroups, and a migration of circulating tumor DNA into a more minimal residual disease–based setting.
Immunotherapy Finds a Foothold in Metastatic Bladder Cancer, But Frontline Challenges Remain
December 14th 2020The emergence of checkpoint inhibitors has transformed the second-line treatment of patients with metastatic bladder cancer. However, questions regarding the utility of immunotherapy in the frontline setting remain unanswered, leaving chemotherapy as the standard-of-care option.
Immunotherapy Finds a Role in Frontline Small Cell Lung Cancer and Mesothelioma
December 14th 2020Checkpoint inhibitors have failed to improve progression-free survival and overall survival as second-line therapy and maintenance therapy in small cell lung cancer, but this class of agents continue to show encouraging activity worthy of a paradigm shift up front.
PARP Inhibitors Pave the Way to Cure in Ovarian Cancer
December 14th 2020Following the results of the SOLO-1 trial, maintenance PARP inhibitors have become the standard of care for patients with BRCA-mutated ovarian cancer but overall survival data are needed to confirm their potentially curative benefit.
Neratinib Improves PFS in HER2+ Breast Cancer With Brain Metastases
December 14th 2020December 14, 2020 - The combination of neratinib and capecitabine showed a 34% reduction in the risk of disease progression or death compared with lapatinib and capecitabine in patients with HER2-positive breast cancer who had central nervous system metastases at baseline.
MSI-H GI and Endometrial Tumors Show High Immunogenicity With Frameshift Mutations
December 14th 2020December 14, 2020 - Microsatellite instability–high tumors in patients with endometrial, colorectal, and stomach carcinomas were found to be enriched in recurrent shared, immunogenic, tumor-specific frameshifts expressed on RNA and protein levels.
Biomarkers Drive ICIs in Colon Cancer
December 14th 2020December 14, 2020 - Immunotherapy agents have shown efficacy in malignant melanoma, kidney cancer, and non–small cell lung cancer, and investigators are examining the efficacy of checkpoint inhibitors in less immunogenic tumors such as colon cancer, particularly in tumors with high microsatellite instability and deficient mismatch repair genes.