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.
FDA Grants Breakthrough Therapy Designation to Venetoclax/Azacitidine for MDS
July 21st 2021The FDA has granted a breakthrough therapy designation to the combination of venetoclax plus azacitidine for use in the treatment of adult patients with previously untreated, intermediate-, high-, and very high–risk myelodysplastic syndromes based on the revised International Prognostic Scoring System.
Ficlatuzumab Plus Chemotherapy Produces Promising Preliminary Clinical Activity in High-Risk AML
July 21st 2021The investigational therapy ficlatuzumab in combination with cytarabine demonstrated encouraging clinical efficacy with favorable tolerability when used as a treatment in patients with high-risk acute myeloid leukemia.
Pamrevlumab Plus Chemo Under Exploration in Novel Pancreatic Cancer Trial Platform
July 20th 2021A new experimental treatment arm examining pamrevlumab in combination with gemcitabine and nab-paclitaxel as a first- or second-line treatment for patients with metastatic pancreatic cancer has been added to the novel clinical trial platform Precision Promise, which is being conducted by the Pancreatic Cancer Action Network.
Adavosertib, With or Without Olaparib, Showed Promising Efficacy in PARP-Resistant Ovarian Cancer
July 20th 2021Shannon Westin, MD, MPH, discusses the key takeaways from the EFFORT trial, future research directions with adavosertib, and the characteristics of PARP inhibitor resistance in patients with ovarian cancer.
Leronlimab Plus Carboplatin Showcases Early Signs of OS Benefit in Metastatic TNBC
July 20th 2021The CCR5 antagonist leronlimab plus carboplatin was shown to result in a 72% decrease in cancer-associated macrophage-like cells, which was linked with an approximate 450% increase in overall survival in 30 patients with metastatic triple-negative breast cancer.
Immunotherapy GEN-1 Demonstrates Acceptable Risk/Benefit Profile in Advanced Ovarian Cancer
July 20th 2021The novel gene-mediated immunotherapy GEN-1 showcased satisfactory safety with an acceptable risk/benefit profile when given over a 6-month period with up to 17 doses in newly diagnosed patients with stage III/IV ovarian cancer.
Durvalumab Plus Chemo Approved in China for Frontline Extensive-Stage SCLC
July 20th 2021The Chinese National Medical Products Administration has approved durvalumab plus standard-of-care platinum chemotherapy, in the form of etoposide plus either carboplatin or cisplatin, as a frontline treatment option for patients with extensive-stage small cell lung cancer.
Novel Vaccine Combos Represent a Promising Treatment Approach in Breast Cancer
July 19th 2021The future of therapeutic vaccines in breast cancer will be dependent on their use in combination with standard anticancer drugs, checkpoint antagonists, and distinct checkpoint inhibitors, Leisha A. Emens, MD, PhD.
Chemoimmunotherapy Shakes Up Metastatic and Early-Stage TNBC
July 17th 2021Chemoimmunotherapy combinations have transformed the treatment landscape for patients with triple-negative breast cancer, but balancing potential efficacy with the risk of toxicity with these regimens is critical in both the metastatic and early-stage settings.
FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Capmatinib in METex14+ NSCLC
July 16th 2021The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic to assist in the identification of patients with metastatic non–small cell lung cancer whose tumors harbor MET exon 14 skipping mutations and who could derive benefit from treatment with capmatinib.
BLA for Vicineum in High-Risk, BCG-Unresponsive NMIBC Remains on Track for Regulatory Decision
July 16th 2021A Late-Cycle Meeting was held to discuss the biologics license application for Vicineum as a potential option for patients with Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder cancer.
Pevonedistat Plus HMAs Provides a Promising Strategy in Higher-Risk MDS
July 16th 2021Daniel Pollyea, MD, MS, discusses the current management of patients with higher-risk myelodysplastic syndrome, the data noted so far with pevonedistat in this paradigm, and other therapies positioned to improve outcomes for this patient population.
Persistent Development of WEE1 Pathway Inhibitors Begins to Pay Off
July 16th 2021The lead novel candidate, the WEE1 inhibitor adavosertib, has been tested in more than 50 completed or ongoing clinical studies but has yet to proceed to a phase 3 trial despite showing promising safety and efficacy as monotherapy and in combination with a range of other cancer therapies.