All Oncology News

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.

Perioperative Durvalumab Plus SOC Shows Promising EFS Results in Muscle-Invasive Urothelial Carcinoma

August 31st 2023

Treatment with neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical surgery and adjuvant durvalumab for patients with muscle-invasive urothelial carcinoma resulted in 2-year event-free survival rates that met the primary end point of the phase 2 SAKK 06/17 trial.

Cracking the Immunotherapy Code Remains a Challenge in Ovarian Cancer

August 31st 2023

Martin Cannon, PhD, details the history of investigating immune checkpoint inhibitors in patients with ovarian cancer and expands on the questions that need to be answered to potentially improve the activity of these agents in this patient population.

Mezigdomide Plus Dexamethasone Elicits Responses With Acceptable Safety in R/R Myeloma

August 30th 2023

Treatment with combination of mezigdomide and dexamethasone produced responses with a safety profile that consisted primarily of myelotoxic adverse effects in heavily pretreated patients with relapsed/refractory multiple myeloma.

Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.

Treatment Sequencing in Refractory Urothelial Carcinoma Requires a Personalized Approach

August 30th 2023

Jue Wang, MD, highlights key takeaways regarding treatment sequencing for patients with relapsed/refractory urothelial carcinoma and the key factors that could help inform decisions for individual patients.

Trifluridine/Tipiracil Plus Bevacizumab Provides Potential First-Line Alternative to Bevacizumab/Capecitabine in mCRC

August 30th 2023

Thierry André, MD, discusses the investigation of trifluridine/tipiracil plus bevacizumab in patients with metastatic colorectal cancer, including how its use as a standard of care in the third line supported its investigation in the first-line setting, the regimen’s efficacy and safety in the SOLSTICE trial, and the importance of this combination for patients in this space despite negative trial results.

Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.

Novartis Discontinues Development of NIS793 in Pancreatic Cancer

August 30th 2023

Novartis will discontinue the development of the anti-TGFß monoclonal antibody NIS793 for the treatment of patients with pancreatic cancer and other malignancies, according to a SEC filing from Xoma.

NDA Submission Planned for EA-114 in Metastatic Breast Cancer Following Positive Type C Meeting With FDA

August 30th 2023

The FDA and Eagle Pharmaceuticals have agreed on the next steps for the development of EA-114, an estrogen receptor antagonist and novel formulation of fulvestrant used in the treatment of postmenopausal women with breast cancer.

City of Hope Appoints Marcel van den Brink, MD, PhD, As President of City of Hope Los Angeles and National Medical Center, and Chief Physician Executive

August 30th 2023

City of Hope announced the appointment of Marcel van den Brink, MD, PhD, as president of City of Hope Los Angeles and National Medical Center, chief physician executive and the Deana and Steve Campbell Chief Physician Executive Distinguished Chair in honor of Alexandra Levine, MD.

Early Data Signal Response With CBX-12 in Advanced or Metastatic Solid Tumors

August 30th 2023

Funda Meric-Bernstam, MD, discusses the safety of CBX-12 and exploring dosage of the agent.

Geptanolimab Elicits Durable Responses and Acceptable Safety in PD-L1+ Cervical Cancer

August 29th 2023

The novel anti-PD-1 antibody geptanolimab demonstrated durable antitumor activity and favorable tolerability in patients with recurrent or metastatic PD-L1–positive cervical cancer who previously progressed on a platinum-based regimen.

Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications

August 29th 2023

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.

FDA Grants Orphan Drug Designation to Bexmarilimab for AML

August 29th 2023

The FDA has granted an orphan drug designation to bexmarilimab for the treatment of patients with acute myeloid leukemia.

Gene Therapy Study Identifies Potential New Treatment for Liver Cancer

August 29th 2023

Gene therapy that induces the body to create microRNA-22, a naturally occurring molecule, successfully treated mice with hepatocellular carcinoma, the most common form of liver cancer.

FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

August 29th 2023

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

Pembrolizumab Plus Trastuzumab and Chemotherapy Receives European Approval in HER2+ Gastric/GEJ Cancer

August 29th 2023

The European Commission has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

TROPiCS-02 Data Reinforce Role of Sacituzumab Govitecan as a SOC in HR+ Breast Cancer

August 29th 2023

Sara M. Tolaney, MD, MPH, highlights updated survival and safety data seen with sacituzumab govitecan in patients with hormone receptor–positive, HER2-negative breast cancer; underscores how Trop-2 and HER2 testing is not necessarily needed for this agent in this population at this time; and shares how ongoing efforts are exploring the utilization of this agent earlier in the treatment course.

Pembrolizumab With COPDAC-28 Consolidation Increases PET Negativity in Classical Hodgkin Lymphoma

August 29th 2023

The addition of pembrolizumab to COPDAC-28 consolidation may augment responses to treatment in pediatric and young adult patients with high-risk classical Hodgkin lymphoma who experience a slow early response to frontline chemotherapy.

FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS

August 29th 2023

The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.