Your AI-Trained Oncology Knowledge Connection!
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 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.
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 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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Ben Creelan, MD, discusses several of the methods evaluating cellular therapies currently in the works across the non–small cell lung cancer field.
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.
Interrupting combination treatment with axitinib and avelumab and switching to avelumab maintenance after a response at 36 weeks led to a decrease in treatment-related toxicities and delayed tumor progression in previously untreated patients with metastatic clear cell renal cell carcinoma.
The European Commission has granted marketing authorization to the combination of zanubrutinib and obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of systemic therapy.
