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.

Dato-DXd Plus Durvalumab Elicits Durable Responses in Metastatic TNBC Regardless of PD-L1 Status

November 22nd 2023

Peter Schmid, FRCP, MD, PhD, discusses the evaluation of combination of the datopotamab deruxtecan and durvalumab in patients with first-line triple-negative breast cancer, details safety and efficacy findings derived from the combination in the BEGONIA trial, and highlights ongoing efforts with this combination.

Taletrectinib Under NMPA Review in China for Advanced or Metastatic ROS1+ NSCLC

November 22nd 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.

Bayer Recalls Oral Larotrectinib Solution Because of Microbial Contamination

November 22nd 2023

Bayer has voluntarily recalled 1 lot of the larotrectinib 20 mg/mL oral solution that is packaged in 100-mL glass bottles because of the presence of Penicillium brevicompactum contamination that was observed during ongoing, routine stability testing.

Sugemalimab Receives Approval in China for Relapsed/Refractory Extranodal NK/T-cell Lymphoma

November 22nd 2023

The National Medical Products Administration of China has approved sugemalimab for use in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma.

SCO-101 Plus FOLFIRI Prolongs Survival in Metastatic Colorectal Cancer

November 22nd 2023

SCO-101 in combination with leucovorin, fluorouracil, and irinotecan (FOLFIRI) prolonged survival in heavily pretreated patients with metastatic colorectal cancer who had no other active treatment options available, according to final data from part 2 of the phase 2 CORIST study.

Fixed-Duration Approaches Provide Promising Survival Benefit for Select Patients With CLL

November 21st 2023

John N. Allan, MD, discusses current data detailing the activity of venetoclax-based, fixed-duration regimens in the frontline setting for patients with chronic lymphocytic leukemia; the synergy and promising efficacy signals seen with BCL-2 and BTK inhibitor combinations; and ongoing research efforts exploring triplet regimens vs other continuous approaches in this space.

Overcoming Resistance Mutations Is a Focus for Novel Therapies in R/R CLL

November 21st 2023

Nicole Lamanna, MD, discusses the challenges of resistance in patients with CLL, highlights treatment being developed for patients who progress on BTK inhibitor– or venetoclax-based regimens, and emphasizes the need for further enrollment onto clinical trials.

Emerging Therapeutic Targets Are Expanding the CLL Treatment Armamentarium

November 21st 2023

Bhagirathbhai Dholaria, MBBS, discusses limitations in the current CLL standards of care that necessitate more effective therapies; BTK inhibitors and degraders on the horizon for this population; and the potential future role of CAR T-cell therapy for patients with CLL.

Ongoing Research Aims to Bring Bispecific Antibodies to Earlier Settings and Novel Combinations in Myeloma

November 21st 2023

Joshua Richter, MD, provides an overview of the current state of bispecific antibodies in multiple myeloma, discusses ongoing investigations of these agents, and expands on their unique toxicities and the need for proactive management.

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.