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.

Pelabresib Plus Ruxolitinib Improves Spleen Volume Reduction in JAK Inhibitor-Naive Myelofibrosis

November 21st 2023

Treatment with the combination of pelabresib and ruxolitinib led to a statistically significant and clinically meaningful improvement in spleen volume reduction vs placebo plus ruxolitinib in patients with JAK inhibitor-naive myelofibrosis, meeting the primary end point of the phase 3 MANIFEST-2 trial.

FDA Approves Companion Diagnostic for Capivasertib Plus Fulvestrant in Advanced HR+/HER2–Breast Cancer

November 21st 2023

The FDA has approved the FoundationOne® CDx for use as a companion diagnostic to identify patients with advanced hormone receptor–positive, HER2-negative advanced breast cancer who may be eligible for treatment with the combination of capivasertib and fulvestrant.

Bezuclastinib/Sunitinib Combination Under Evaluation in Advanced GIST

November 21st 2023

The TKI bezuclastinib plus standard-of-care sunitinib may become the new second-line standard treatment for patients with gastrointestinal stromal tumor that has progressed on imatinib.

MRT-2359 Shows Favorable Tolerability in Heavily Pretreated MYC-Driven Solid Tumors

November 21st 2023

MRT-2359 had acceptable tolerability with a favorable pharmacokinetic and pharmacodynamic profile in heavily pretreated patients with MYC-driven solid tumors, including lung cancer and high-grade neuroendocrine cancer.

FDA Approval Sought for Amivantamab Plus Chemo in EGFR+ Advanced NSCLC Following Osimertinib Progression

November 20th 2023

A supplemental biologics license application seeking the approval of amivantamab in combination with platinum-based chemotherapy for the treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 19 deletions has been submitted to the FDA.

Evolving Treatment Patterns Lead to Improved Outcomes in Relapsed/Refractory MCL

November 20th 2023

Patients with relapsed/refractory mantle cell lymphoma have experienced event-free survival and overall survival benefits due to advances in second-line treatment approaches over time.

Refining Treatment Approaches Remains a Priority in High-Risk MCL

November 20th 2023

Andre Goy, MD, discusses the agents that are currently available for the treatment of patients with relapsed/refractory mantle cell lymphoma, explains the prevalence of high-risk features in this population, and emphasizes the importance of enrolling patients into clinical trials to move the needle forward.

Bemcentinib Plus SOC Is Well Tolerated, But Does Not Improve Efficacy in Metastatic Melanoma

November 20th 2023

The addition of bemcentinib to the standard-of-care therapies of pembrolizumab or dabrafenib plus trametinib was well tolerated in patients with metastatic melanoma; however, it did not lead to improvements in overall response rate, progression-free survival, or overall survival vs SOC alone.

EO2401 Plus Nivolumab and Bevacizumab Shows Activity in Progressive/Recurrent Glioblastoma

November 20th 2023

The use of the first-in-class, microbiome-derived therapeutic vaccine EO2401 in combination with nivolumab with or without bevacizumab produced clinical activity and was well tolerated in patients with progressive/recurrent glioblastoma.

Rucaparib Receives EC Approval for Advanced Ovarian Cancer

November 20th 2023

The European Commission has approved rucaparib as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy.

FDA’s ODAC to Review Data for Ide-Cel in Triple-Class Exposed R/R Myeloma

November 20th 2023

The FDA’s Oncologic Drugs Advisory Committee will meet to review data from the supplemental biologics license application seeking the approval of idecabtagene vicleucel for use in earlier lines of treatment for patients with triple-class exposed relapsed/refractory multiple myeloma.

Lenalidomide Plus Rituximab Elicits Prolonged Responses in Mantle Cell Lymphoma

November 20th 2023

Initial induction therapy with the immunomodulatory agent lenalidomide plus the anti-CD20 monoclonal antibody rituximab led to prolonged, durable responses with a manageable safety profile in patients with previously untreated mantle cell lymphoma.

Tebentafusp Sustains OS Benefit in Previously Untreated, Metastatic Uveal Melanoma

November 20th 2023

Paul Nathan, MBBS, PhD, MRCP, discusses the differences between cutaneous melanoma and uveal melanoma that have led to unique unmet needs for patients with the latter malignancy; updated findings from the IMCgp100-202 trial; and how these findings may influence future clinical practice.

Ovarian Cancer: New Biological Markers Found That May Predict Which Patients Won't Respond to Chemotherapy

November 19th 2023

Using a novel proteogenomic strategy and a variety of machine learning tools, investigators from the Icahn School of Medicine at Mount Sinai and colleagues have identified a 64-protein signature that may predict a subset of ovarian cancer patients who are unlikely to respond to chemotherapy.

CAR-M Therapy CT-0508 Shows Promise in HER2-Overexpressing Recurrent/Metastatic Solid Tumors

November 19th 2023

The HER2-directed CAR-macrophage therapy CT-0508 displayed a tolerable safety profile and signs of antitumor activity in patients with a variety of solid tumors.

New RNA-based Therapy Combats Melanoma in Mouse Models

November 18th 2023

Investigators at the Icahn School of Medicine at Mount Sinai have designed an innovative RNA-based strategy to activate dendritic cells—which play a key role in immune response—that eradicated tumors and prevented their recurrence in mouse models of melanoma.

Allogeneic HCT Provides OS Benefit Independent of TP53 Allelic Status in MDS

November 18th 2023

Patients with myelodysplastic syndrome harboring a TP53 mutation experienced a survival benefit with allogeneic hematopoietic cell transplantation compared with non-HCT treatment regardless of TP53 allelic status.

KB-0742 Exhibits Tolerable Safety and Activity in Relapsed/Refractory Solid Tumors

November 17th 2023

The selective CDK9 inhibitor KB-0742 displayed anti-tumor activity and manageable safety as a single agent in heavily pretreated patients with relapsed/refractory, transcriptionally addicted solid tumors, according to data from a phase 1 trial (NCT04718675).

Novel Cellular Therapies Aim to Address Off-Tumor, On-Target Toxicities in NSCLC

November 17th 2023

Ben Creelan, MD, discusses several of the methods evaluating cellular therapies currently in the works across the non–small cell lung cancer field.

Raludotatug Deruxtecan Elicits Early Efficacy and Safety in Platinum-Resistant Ovarian Cancer

November 17th 2023

The emerging CDH6-directed antibody-drug conjugate raludotatug deruxtecan had a manageable safety profile, generated pharmacokinetic activity, and produced early evidence of clinical response in patients with heavily pretreated, platinum-resistant ovarian cancer.