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.

Exploratory Analyses of KATHERINE Trial Inform Adjuvant T-DM1 Use in HER2+ Breast Cancer

December 18th 2023

Maria Hafez, MD, spotlights the KATHERINE trial in HER2-positive breast cancer, expanding on the respective toxicity profiles of T-DM1 and trastuzumab that were identified in an exploratory safety analysis of the trial; updated outcomes with T-DM1 in those with residual invasive disease after neoadjuvant treatment and surgery; and more.

SD-101 With Immune Checkpoint Inhibition Generates Positive Results in Uveal Melanoma Liver Metastasis

December 18th 2023

Treatment with SD-101 distributed via pressure-enabled drug delivery with immune checkpoint inhibition was tolerated and resulted in the depletion of Tregs, M-MDSCs, and M2 macrophages in liver metastases in patients with uveal melanoma.

Moore Details Ongoing Research Aiming to Fill Unmet Needs in Ovarian Cancer

December 18th 2023

Kathleen N. Moore, MD, MS, expands on the importance of continuing to investigate PARP inhibitors in ovarian cancer and highlights key updates to have come out of the 2023 ESMO Congress

Lutetium Lu 177 Vipivotide Tetraxetan Addresses Unmet Need in Taxane-Naive mCRPC

December 18th 2023

Oliver Sartor, MD, discusses the significance of the data with lutetium Lu 177 vipivotide tetraxetan in the open-label, multicenter randomized study, highlights potential next steps with this approach, and expands on unique adverse effects to be aware of when treating patients with this drug.

FDA Issues Complete Response Letter to Cosibelimab for Cutaneous Squamous Cell Carcinoma

December 18th 2023

The FDA has issued a complete response letter to the biologic license application seeking the approval of cosibelimab for use in patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation.

Lung Cancer Screening Dramatically Increases Long-term Survival Rate

December 18th 2023

Diagnosing early-stage lung cancer with low-dose computed tomography screening drastically improves the survival rate of cancer patients over a 20-year period, according to a large-scale international study being presented by Mount Sinai researchers at the annual meeting of the Radiological Society of North America.

TRT in Patients With Prostate Cancer on Active Surveillance: Are We Really Putting Gas on Fire?

December 18th 2023

Investigators hypothesized that testosterone replacement does not have a negative impact on the oncologic outcomes of treatment-naive patients with prostate cancer on surveillance and they performed a retrospective review of an institutional active surveillance prostate cancer database.

Individual Disease Histology and Local Control Are Key Considerations in Endometrial Cancer Care

December 18th 2023

Hope Cottrill, MD, highlights practice-changing developments in endometrial cancer care, the benefits of local control with radiation in patients with locally aggressive disease, and questions that remain regarding treatment sequencing with immunotherapy.

Cantex and Allegheny Health Network Announce Initiation of a Phase 1/2 Study of Azeliragon in Patients Refractory to First-Line Treatment of Metastatic Pancreatic Cancer

December 17th 2023

A phase 1/2 study will assess the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer.

Repotrectinib May Serve as a New Standard of Care Across Treatment Lines in ROS1+ NSCLC

December 17th 2023

Alexander Drilon, MD, highlights how the approval of repotrectinib addresses the need for improved therapies for patients who have progressed on a previous TKI and delves into notable neurologic toxicities seen with the agent.

Mount Sinai Researchers Find More Than 4,700 Gene Clusters Crucial for Prognosis in 32 Cancer Types

December 16th 2023

Groundbreaking study opens new avenues for future treatment and diagnosis.

OBX-115 Elicits Responses in Advanced or Metastatic Melanoma

December 16th 2023

The tumor-infiltrating lymphocyte cell therapy OBX-115 produced responses with no dose-limiting toxicities in heavily pretreated patients with advanced or metastatic melanoma whose who had progressed on anti–PD-1 and anti–CTLA-4 therapy with disease that was primary-resistant to immune checkpoint inhibitor therapy.

Shitara and Xu Discuss Potential FDA Approval of Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma

December 15th 2023

Rui-Hua Xu, MD, PhD, and Kohei Shitara, MD, expand on the advantages of targeting CLDN18.2 with zolbetuximab in gastric/GEJ adenocarcinoma and key efficacy data from the GLOW and SPOTLIGHT trials in support of zolbetuximab’s potential FDA approval.

Oral CELMoD Mezigdomide May Address Logistical Challenges Linked With R/R Myeloma Management

December 15th 2023

Paul G. Richardson, MD, shares clinical findings and several case studies showcasing the encouraging activity and safety of mezigdomide in patients with relapsed/refractory multiple myeloma.

FDA Approves Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer

December 15th 2023

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

RCC Research May Lead to SOC Improvements and Individualized Treatment Plans

December 15th 2023

Marijo Bilusic, MD, PhD, highlights key insights about renal cell carcinoma that were presented at the meeting covering considerations on sequencing TKIs, the need for further research to elucidate novel therapies, and the importance of offering clinical trials to all patients with genitourinary malignancies.

Pembrolizumab Plus Lenvatinib Misses Both Survival End Points in Advanced, Recurrent Endometrial Cancer

December 15th 2023

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.

FDA Grants Fast Track Status to Naporafenib Plus Trametinib for Advanced NRAS-Mutated Melanoma

December 15th 2023

The FDA has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.

Zanubrutinib Favored Over Bendamustine/Rituximab Combination Across Biomarker Subgroups in CLL/SLL Without del(17p)

December 15th 2023

Treatment with zanubrutinib conferred a PFS benefit vs bendamustine plus rituximab across most biomarker subgroups of patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma without del(17p), according to findings from the phase 3 SEQUOIA trial.

FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

December 14th 2023

The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI.