Courtney Flaherty

Articles

FDA Grants Fast Track Designation to BI 764532 for DLL3+ Large-Cell NEC of the Lung

December 4th 2023

The FDA has granted a fast track designation to BI 764532 for use as a therapeutic option in patients with advanced or metastatic DLL3-expressing large-cell neuroendocrine carcinoma of the lung who experienced disease progression after treatment with 1 or more lines of therapy, including platinum-based chemotherapy.

ADC Doublets Represent a Promising Novel Approach for Treatment-Resistant mUC

December 4th 2023

Bradley A. McGregor, MD, expands on the feasibility and safety considerations addressed through the design and methodology of the DAD study; highlights dose-limiting toxicities and early responses seen with sacituzumab govitecan plus enfortumab vedotin in treatment-resistant mUC; and explains how these results support further investigation of other ADC doublets.

FDA Approval of Nirogacestat Introduces First Systemic SOC Therapy for Desmoid Tumors

December 1st 2023

Mrinal M. Gounder, MD, discusses the rationale for investigating nirogacestat in the DeFi trial, highlights patient-reported outcomes with the agent in this study, and discusses potential next steps for better utilizing T2-weighted magnetic resonance imaging in addition to RECIST criteria when assessing tumor volume and dimensions in desmoid tumors.

Multidisciplinary Collaboration and Molecular Testing Are Integral to Treatment Decision-Making in NSCLC

November 30th 2023

Lyudmila A. Bazhenova, MD, expanded on key considerations when navigating the use of perioperative immunotherapy for patients with or without oncogenically-driven lung cancers, the importance of multidisciplinary collaboration when deciding on a treatment plan, and the need for increased and earlier implementation of biomarker testing in all patients with lung cancer.

Long-Term Survival Benefit With PD-1 Monotherapy Correlated With High PD-L1 Expression in Advanced NSCLC

November 29th 2023

Biagio Ricciuti, MD, discusses the need to improve the identification of patients with advanced non–small cell lung cancer that benefit most from immune checkpoint inhibition.

Expansion of First-Line Treatment Options in Unresectable HCC Requires Consideration of High-Risk Disease Features

November 29th 2023

Reena J. Salgia, MD, discusses the advantages of utilizing an atezolizumab plus bevacizumab backbone as standard frontline therapy in unresectable HCC; how factors such as Child-Pugh B score, bleeding, and other high-risk features impact treatment selection; and the unmet needs that still need to be addressed for this patient population.

IBI351 NDA Under NMPA Review in Advanced KRAS G12C–Mutant NSCLC

November 28th 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted and granted priority review to the new drug application for IBI351 in the treatment of patients with advanced, KRAS G12C–mutant NSCLC who have received at least 1 prior systemic therapy.

Emerging TROP-2 Directed ADCs Show Promise in Advanced NSCLC

November 28th 2023

Benjamin Philip Levy, MD, discusses the current landscape of emerging antibody-drug conjugates (ADCs) and their early activity in advanced lung cancer, the potential utility of oncogene-directed ADCs for patients with driver mutations, and more.

Frontline Aumolertinib Plus Anlotinib Elicits Responses in EGFR-Mutant NSCLC With Brain Metastases

November 26th 2023

Aumolertinib plus anlotinib resulted in intracranial efficacy when used in the first-line treatment of patients with EGFR-mutant non–small cell lung cancer who have brain metastases.

Novel Immunomodulatory Vaccine Plus Pembrolizumab Shows Early Activity in PD-L1–High NSCLC Adenocarcinoma

November 23rd 2023

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.

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.

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.

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.

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.

FDA Approval of Fruquintinib Expands Later-Line Treatment Options in mCRC

November 17th 2023

John 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.

Olaparib With/Without Cediranib Does Not Improve OS Vs Chemo in Recurrent Platinum-Sensitive Ovarian Cancer

November 16th 2023

The use of olaparib as a monotherapy or in combination with cediranib did not provide a statistically significance overall survival benefit compared with standard-of-care platinum-based chemotherapy in patients with recurrent, platinum-sensitive ovarian cancer.

Masofaniten Plus Enzalutamide Demonstrates Safety and Durable Responses in mCRPC

November 16th 2023

Masofaniten 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.

CCR4 Antagonists May Bolster Immune Responses With Checkpoint Inhibitors in PD-L1+ NSCLC

November 16th 2023

The 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.

FDA Grants Orphan Drug Designation to SIRPant-M in T-Cell Lymphoma

November 15th 2023

The FDA has granted an orphan drug designation to SIRPant-M™ as a potential therapeutic option for patients with T-cell lymphoma.

LITESPARK-013 Data Support RP2D of Belzutifan as Standard Option in Advanced ccRCC

November 11th 2023

Administration 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.