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.
Lorlatinib Data Published in NEJM Underscore Benefits Over Crizotinib in ALK+ NSCLC
November 19th 2020November 19, 2020 - Lorlatinib has been found to significantly prolong progression-free survival, elicit a higher overall and intracranial response, and improve quality of life compared with crizotinib in treatment-naïve patients with advanced ALK-positive non–small cell lung cancer.
Charting the Course for Patients With High-Risk Colon Cancer: 3 Months Versus 6 Months
November 19th 2020In 5 years, it is estimated that approximately 20% of patients with stage II disease and 35% with stage III disease will experience disease recurrence. These estimates highlight the need to pursue progress in adjuvant systemic therapy in order to decrease recurrence rates and improve survival.
Real-World Impact of Low-Grade AEs Needs a Closer Look
November 18th 2020Although PARP inhibitors are generally reasonably well tolerated, certainly compared with platinum and other routinely employed cytotoxic antineoplastic drugs, the majority of patients receiving PARP inhibitors in multiple reported clinical trials reported low-grade nausea and fatigue.
FDA Lifts Clinical Hold on MELANI-01 Trial With CAR T Product UCARTCS1 in Myeloma
November 18th 2020November 18, 2020 - The FDA has decided to lift the clinical hold placed on the phase 1 MELANI-01 trial, which is examining the CAR T-cell therapy UCARTCS1 as a treatment for patients with relapsed/refractory multiple myeloma.
Acalabrutinib Misses the Mark in Patients Hospitalized With COVID-19–Related Respiratory Symptoms
November 18th 2020November 18, 2020 - The addition of the oral BTK inhibitor acalabrutinib to best supportive care in patients with respiratory symptoms from coronavirus disease 2019 infection failed to increase the proportion of patients who remained alive and free of respiratory failure, missing the primary efficacy end points of the 2 phase 2 CALAVI trials.
Ruesch Center Symposium to Spotlight Advances, Applications in GI Cancers, Luminary Awards
November 17th 2020November 17, 2020 — The 11th Annual Ruesch Center Symposium, taking place virtually on November 20 to 21, 2020, will feature sessions that span innovations in gastrointestinal cancer, advances in nuclear imaging and therapy for neuroendocrine tumors, precision oncology web educational resource, and patient symposia, bringing participants together in a forum for discussion, networking, and debate on pressing issues in the field.
Tislelizumab Improves Survival in Second- or Third-Line NSCLC
November 17th 2020November 17, 2020 - The PD-1 inhibitor tislelizumab was found to improve overall survival versus docetaxel in the second- or third-line treatment in patients with locally advanced or metastatic non–small cell lung cancer who progressed on previous platinum-based chemotherapy.
COVID-19 Delays FDA Review of Liso-Cel for Relapsed/Refractory Large B-Cell Lymphoma
November 17th 2020November 17, 2020 - The review of the biologics license application for the CAR T-cell product lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies has been delayed.
Should All Elderly Patients With Newly Diagnosed Multiple Myeloma Receive Monoclonal Antibodies?
November 17th 2020In light of the recent approvals of combination anti-myeloma regimens containing monoclonal antibodies, as well as the robust pipeline of novel targeted agents likely to be approved in the next year, there is much optimism in the field of multiple myeloma.
NICE Recommends Caplacizumab for Acute Acquired Thrombotic Thrombocytopenic Purpura
November 16th 2020November 16, 2020 — The United Kingdom’s National Institute for Health and Care Excellence has recommended caplacizumab-yhdp with plasma exchange and immunosuppression for the treatment of an acute episode of acquired thrombotic thrombocytopenic purpura in adults and those aged 12 years and over who weigh at least 40 kg.
FDA Approves PD-L1 IHC 22C3 pharmDx as Companion Diagnostic for Pembrolizumab in TNBC
November 16th 2020November 16, 2020 — The FDA has approved the PD-L1 IHC 22C3 pharmDx to aid in the identification of patients with triple-negative breast cancer who are eligible to receive the PD-1 inhibitor pembrolizumab.
Plinabulin/Pegfilgrastim Combo Reduces Rate of Chemotherapy-Induced Neutropenia
November 16th 2020November 16, 2020 - The combination of plinabulin and pegfilgrastim showed a statistically significant improvement in the rate of prevention of grade 4 neutropenia versus pegfilgrastim alone in patients with cancer undergoing chemotherapy.
Reddy Reviews Paradigm Shifts in CD30-Positive PTCL, Next Steps for Research
November 16th 2020Nishitha M. Reddy, MD, MBBS, discusses the significance of the ECHELON-2 trial in peripheral T-cell lymphoma, the need for novel therapies for those with CD30-negative disease, and the excitement surrounding duvelisib in the relapsed/refractory setting.
Fixed-Dose Pertuzumab/Trastuzumab Combo Nears EU Approval for HER2+ Breast Cancer
November 15th 2020November 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the fixed-dose combination of pertuzumab plus trastuzumab with hyaluronidase-zzxf for administration via subcutaneous injection in combination with intravenous chemotherapy in the treatment of patients with early and metastatic HER2-positive breast cancer
Cabozantinib Plus Nivolumab/Ipilimumab Under Exploration in Intermediate-, Poor-Risk RCC
November 14th 2020November 14, 2020 - A novel combination comprised of the TKI cabozantinib plus the PD-1 inhibitor nivolumab and the CTLA-4 inhibitor ipilimumab is under exploration in treatment-naïve patients with intermediate or poor risk advanced or metastatic renal cell carcinoma in the phase 3 COSMIC-313 trial.