MedPath

Tagged News

Merck Defends Current GARDASIL 9 Dosing Amid Regulatory Discussions on Single-Dose Regimen

Oncology
  • Merck affirmed its position that CDC recommendations should remain consistent with approved GARDASIL 9 labeling until sufficient data enables FDA and European Commission to license alternate dosing regimens.
  • The FDA has established high evidentiary standards for single-dose regimen approval, requiring comparable effectiveness data, demonstration of non-reduced efficacy beyond cervical persistent infection, and efficacy data in men.
  • GARDASIL 9 currently uses 2-dose regimens for ages 9-14 and 3-dose regimens for ages 15-45, with over 10 years of real-world experience supporting these approved schedules.
  • Merck has invested over $2 billion in manufacturing capacity expansion, doubling HPV vaccine supply twice between 2017-2024 to meet global demand across 150+ national immunization programs.

Duke Study Shows Enzalutamide Combination Extends Survival by 30% in Metastatic Prostate Cancer

Oncology
  • Duke University researchers demonstrated that combining enzalutamide with standard hormonal therapy extends survival by 30% in men with metastatic prostate cancer.
  • The treatment extended life expectancy from four to seven years in patients with high-volume disease, representing a significant clinical advancement.
  • More than 75% of patients with low-volume disease achieved survival beyond five years with the combination therapy approach.

Nykode Therapeutics Presents Promising Immunotherapy Data for HPV16-Positive Cancer and Solid Tumors at ASCO 2025

Oncology
  • Nykode Therapeutics has presented new clinical data at ASCO 2025 for two cancer immunotherapy candidates, VB10.16 and VB10.NEO, both showing robust immune responses when combined with atezolizumab.
  • VB10.16 demonstrated durable clinical responses in HPV16-positive cervical cancer patients, with stronger T cell responses associated with reduced systemic immunosuppression during treatment.
  • VB10.NEO, a personalized cancer neoantigen vaccine, induced neoantigen-specific immune responses in 100% of heavily pretreated solid tumor patients, with de novo responses in 85% and durable T cell clone expansion in 82%.

Mythic Therapeutics' MYTX-011 Shows Promising Efficacy in Phase 1 Trial for Advanced NSCLC

OncologyTargeted Therapy
  • Mythic Therapeutics will present updated dose escalation data from its Phase 1 KisMET-01 study of MYTX-011, a cMET-targeting antibody-drug conjugate, at the 2025 ASCO Annual Meeting.
  • The preliminary results demonstrate meaningful anti-tumor activity in cMET-positive non-small cell lung cancer patients across various cMET expression levels, histologies, and genetic alterations.
  • MYTX-011 leverages Mythic's proprietary FateControl™ technology, designed to enhance ADC uptake in tumor cells while minimizing impact on healthy tissues.

Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

NCT05652868RecruitingPhase 1
Mythic Therapeutics
Posted 3/23/2023

Ruxolitinib Shows Promise in Treating CAR T-Cell Therapy-Induced Parkinsonism in Multiple Myeloma

CAR-TNeurologyOncology
  • Researchers report successful treatment of ciltacabtagene autoleucel-induced parkinsonism in multiple myeloma patients using the JAK inhibitor ruxolitinib, offering a potential solution for this serious complication.
  • Both patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) alongside parkinsonism, suggesting a possible connection between these conditions in CAR T-cell therapy recipients.
  • The findings are particularly significant as CAR T-cell therapy expands to earlier treatment lines for multiple myeloma, highlighting the urgent need for effective management strategies for neurological complications.

E7386 Shows Promising Results in Advanced Endometrial Cancer Trial with 30% Response Rate

Oncology
  • Eisai's Phase Ib trial of E7386 in combination with lenvatinib demonstrated a 30% overall response rate in advanced endometrial cancer patients who progressed after platinum-based chemotherapy and immunotherapy.
  • Among patients without prior lenvatinib treatment, the response rate was even higher at 42.9%, suggesting enhanced efficacy in this specific patient population.
  • The combination therapy showed a manageable safety profile, with patient enrollment for the dose-optimization phase already initiated to further refine the treatment regimen.

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

NCT04008797RecruitingPhase 1
Eisai Inc.
Posted 7/11/2019

Servier to Present Phase 3 Data on IDH-Mutated Cancer Therapies at ASCO 2025

Precision MedicineTargeted TherapyOncology
  • Servier will showcase its precision medicine research for IDH-mutated cancers at the 2025 ASCO Annual Meeting in Chicago, focusing on chondrosarcoma, cholangiocarcinoma, and myelodysplastic syndrome.
  • The company, which allocates over 65% of its R&D budget to oncology, will present updates on several Phase 3 programs aimed at developing new treatment options for patients with IDH-mutated cancers.
  • As a global leader in IDH-mutant targeted therapies, Servier's presentations will reinforce its commitment to advancing precision medicine through mutation identification and understanding cancer progression mechanisms.

Flatiron Health to Present 14 Real-World Oncology Data Studies at ASCO 2025

AIReal World EvidenceOncology
  • Flatiron Health will showcase 14 abstracts at ASCO 2025, leveraging AI and real-world data from over five million cancer patients to generate actionable evidence for improved cancer care.
  • Key research includes the largest real-world study of ctDNA testing in early-stage breast cancer, an assessment of racial disparities in PSMA-PET scan usage for prostate cancer patients, and innovations in clinical trial enrollment.
  • The company's research aligns with ASCO's 2025 theme "Driving Knowledge to Action: Building a Better Future" by using advanced machine learning and AI to transform patient experiences into knowledge for a more connected oncology ecosystem.

Rigel Pharmaceuticals Unveils Promising Final Data from GAVRETO and REZLIDHIA Clinical Trials at ASCO and EHA 2025

OncologyTargeted TherapyPrecision Medicine
  • Final data from the Phase 1/2 ARROW study demonstrates GAVRETO's durable efficacy in RET fusion-positive NSCLC, with a 70.3% overall response rate and median overall survival of 44.3 months.
  • GAVRETO shows promising anti-tumor activity in various RET fusion-positive solid tumors beyond lung cancer, including a 100% response rate in pancreatic cancer patients.
  • REZLIDHIA data supports its potential clinical benefit when used in earlier treatment lines for relapsed/refractory AML patients and as maintenance therapy, with particularly strong outcomes in patients with fewer prior therapies.

Exelixis Reports Promising Results for Zanzalintinib Combination in Advanced Kidney Cancer

Oncology
  • Zanzalintinib combined with nivolumab demonstrated a 63% objective response rate and 90% disease control rate in previously untreated advanced clear cell renal cell carcinoma patients.
  • The combination therapy showed durable responses with a 12-month duration of response of 73.4% and median progression-free survival of 18.5 months in the nivolumab arm.
  • Results from the STELLAR-002 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting, supporting further evaluation of zanzalintinib-based regimens.

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

NCT05425940Active, Not RecruitingPhase 3
Exelixis
Posted 9/7/2022

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

NCT04195750Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/27/2020

Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

NCT05176483Active, Not RecruitingPhase 1
Exelixis
Posted 12/14/2021

Trial of XL092 in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

NCT06863311RecruitingPhase 2
Karie Runcie
Posted 9/1/2025

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.