Jonathan W. Riess, MD, MS, discusses how prior data led to the investigation of IO102-IO103 in combination with pembrolizumab in patients with PD-L1–high non–small cell lung cancer adenocarcinoma and details the initial efficacy and safety data reported in this population.
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Taletrectinib Under NMPA Review in China for Advanced or Metastatic ROS1+ NSCLC
November 22nd 2023The 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.
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Fixed-Duration Approaches Provide Promising Survival Benefit for Select Patients With CLL
November 21st 2023John 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.
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EO2401 Plus Nivolumab and Bevacizumab Shows Activity in Progressive/Recurrent Glioblastoma
November 20th 2023The 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.
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Raludotatug Deruxtecan Elicits Early Efficacy and Safety in Platinum-Resistant Ovarian Cancer
November 17th 2023The 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.
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FDA Approval of Fruquintinib Expands Later-Line Treatment Options in mCRC
November 17th 2023John Lindsay Marshall, MD, sheds light on the significance of the FDA approval of fruquintinib for patients with heavily pretreated metastatic colorectal cancer and discusses the efficacy and safety data from the FRESCO and FRESCO-2 trials that supported the decision in this population.
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Masofaniten Plus Enzalutamide Demonstrates Safety and Durable Responses in mCRPC
November 16th 2023Masofaniten administered in combination with enzalutamide (Xtandi) was tolerable, pharmacokinetically active, and led to a decrease in prostate-specific antigen levels at the recommended phase 2 dose in patients with metastatic castration-resistant prostate cancer.
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CCR4 Antagonists May Bolster Immune Responses With Checkpoint Inhibitors in PD-L1+ NSCLC
November 16th 2023The addition of tivumecirnon to pembrolizumab was safe, well-tolerated, and clinically active vs the historical activity of pembrolizumab monotherapy in patients with checkpoint inhibitor–naive non–small cell lung cancer.
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LITESPARK-013 Data Support RP2D of Belzutifan as Standard Option in Advanced ccRCC
November 11th 2023Administration of the hypoxia-inducible factor–2α inhibitor belzutifan (Welireg) at the recommended phase 2 dose of 120 mg daily produced comparable toxicities and efficacy outcomes to that of a daily 200-mg dose of the agent in patients with advanced clear cell renal cell carcinoma.
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FDA Approval of Momelotinib May Establish New SOC for Myelofibrosis With Anemia
November 2nd 2023Andrew T. Kuykendall, MD, discusses the importance of the approval of momelotinib in the treatment of patients with anemic symptomatic myelofibrosis, key efficacy and safety data from the MOMENTUM trial that supported the decision, and unanswered questions regarding the agent’s potential role in other subsets within this population.
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Elranatamab Approaches EU Approval for Heavily Pretreated Relapsed/Refractory Multiple Myeloma
November 1st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of elranatamab-bcmm for the treatment of adult patients with relapsed/refractory multiple myeloma who were previously treated with 3 or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who experienced disease progression on their last therapy.
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Sacituzumab Govitecan Plus Enfortumab Vedotin Shows Early Promise in Metastatic Urothelial Carcinoma
October 31st 2023Combining sacituzumab govitecan-hziy and enfortumab vedotin-ejfv was safe, feasible, and produced high and early response rates in patients with treatment-resistant metastatic urothelial cancer.
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Postoperative ctDNA Status May Prognosticate DFS Outcomes in Resected CRC
October 30th 2023Postoperative circulating tumor DNA (ctDNA)–based minimal residual disease status demonstrated prognostic value for patients with stage I to IV resected colorectal cancer, showing that those with positive ctDNA after surgery have significantly lower disease-free survival outcomes at 24 months vs those who were ctDNA negative.
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Social Determinants of Health Impact Survival Outcomes in Patients With Hematologic Malignancies
October 29th 2023Marisol Miranda-Galvis, DDS, MS, PhD, highlights the importance of understanding which social determinants of health have the greatest influence on treatment-related outcomes in patients with hematologic malignancies, expands on key variables identified in a systematic review of these disparities, and emphasizes the importance of continuing to implement new strategies to increase access to quality treatments.
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Ricardo D. Parrondo, MD, highlights the current use of covalent BTK inhibitors in chronic lymphocytic leukemia, potential roles for the non-covalent BTK inhibitor pirtobrutinib, and the importance of future research on time-limited treatment options for patients with newly diagnosed chronic lymphocytic leukemia.
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Danielle K. DePalo, MD, explains the lack of research directly comparing first-line treatment options for patients with unresectable melanoma in-transit metastases, expands on the safety and efficacy of 3 treatment modalities for these patients, and underscores the need for more data to inform the management of these patients.
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Luspatercept Approval Shifts Treatment Landscape of Anemia in Lower-Risk MDS
October 24th 2023Uwe Platzbecker, MD, discusses how to navigate decisions for the first-line treatment of anemia in patients with lower-risk MDS in light of luspatercept’s approval, expands on key data from the COMMANDS trial, and addresses potential concerns from clinicians who are uncertain about when to utilize this agent in the frontline setting in clinical practice.
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Vivek K. Narayan, MD, MS, spotlights 3 case studies of patients with metastatic prostate cancer, delving into the influence of their unique mutational status on treatment decisions, scenarios in which to utilize PARP inhibitor monotherapy vs combination regimens, and key trials that support the use of each approach.
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Dendritic Cell Vaccination Fails to Improve OS, Still Bolsters Immune Activation in Mesothelioma
October 16th 2023Joachim G. J. V. Aerts, MD, PhD, discusses how dendritic cell vaccines could bolster historically poor responses to immunotherapy in patients with mesothelioma, reports and provides potential explanations for negative results from the DENIM trial, and details a potential role for this therapy in earlier lines of mesothelioma treatment.
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Acalabrutinib Is Associated With Low Frequency of Cardiac Events Across 3 Randomized Trials in CLL
October 9th 2023Administration of acalabrutinib to patients with chronic lymphocytic leukemia with or without cardiovascular disorders at baseline results in a numerically decreased incidence of overall treatment-related cardiac toxicities and a comparable safety profile vs comparator CLL therapies such as ibrutinib.
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Retrospective Analysis Sheds Light on Mutations Linked With BTK Inhibitor Resistance in CLL
October 8th 2023Patients with chronic lymphocytic leukemia who experience disease progression during treatment with either covalent or noncovalent BTK inhibitors displayed a higher frequency of BTK mutations in L528W as well as RAS/RAF/MAPK pathway alterations, indicating that these alterations may play a role in the development of BTK inhibitor resistance.
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Cilta-Cel Leads to High PFS Rates in Patients With Multiple Myeloma and Poor Prognostic Features
September 30th 2023Patients with multiple myeloma exhibiting poor prognostic features, such as high-risk cytogenetics, soft-tissue plasmacytoma, ISS stage III disease, and triple-class exposure, experienced significant progression-free survival benefit with ciltacabtagene autoleucel.
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Zotatifin Triplet May Improve Outcomes Post–CDK4/6 Inhibition in ER+ Breast Cancer
September 24th 2023Ezra Rosen, MD, PhD, highlights the early-phase investigation of zotatifin in estrogen receptor-positive metastatic breast cancer, explains the agent’s unique mechanism of action as well as its efficacy and safety in a heavily pretreated population, and underscores the need for improved sequencing of the myriad of treatment options in the post–CDK4/6 inhibitor space.
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Ifinatamab Deruxtecan Demonstrates Robust Efficacy, Acceptable Safety in SCLC
September 21st 2023Melissa L. Johnson, MD, spotlights the early-phase investigation of ifinatamab deruxtecan in advanced solid tumors, discusses the efficacy and safety of the agent in patients with small cell lung cancer, and emphasizes how results from a subgroup analysis support its continued investigation.
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Luspatercept Provides Frontline Alternative to ESAs For Lower-Risk MDS and Anemia
September 21st 2023Uwe Platzbecker, MD, discusses the efficacy and safety data from the COMMANDS trial that supported the approval, and the next steps planned for luspatercept’s investigation in patients with lower-risk MDS who are transfusion independent.
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First-line Toripalimab Plus Sorafenib Elicits Responses in Unresectable Hepatocellular Carcinoma
September 19th 2023The addition of toripalimab to standard-of-care sorafenib in the frontline setting demonstrated preliminary efficacy and tolerability in patients with unresectable hepatocellular carcinoma.
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