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Elucent Medical's EnVisio X1 Surgical Navigation System Receives FDA Breakthrough Device Designation

Oncology
  • Elucent Medical's EnVisio X1 In-Body Spatial Intelligence System has received FDA Breakthrough Device Designation, potentially accelerating its path to market for soft tissue surgical navigation.
  • The system features permanently implantable SmartClip markers and real-time 3D guidance technology that wirelessly tracks surgical instruments, enhancing precision during thoracic and abdominal soft tissue excisions.
  • This innovative technology aims to improve surgical outcomes by enabling more precise excisions, reducing positive margins, and minimizing the need for repeat procedures in cancer surgeries.

Narmafotinib Combination Shows Superior Response in Pancreatic Cancer ACCENT Trial

Targeted TherapyOncology
  • Amplia Therapeutics' Phase 1b/2a ACCENT trial has recorded 15 confirmed partial responses in pancreatic cancer patients receiving narmafotinib combined with standard chemotherapy.
  • The trial results demonstrate that adding narmafotinib, a highly selective FAK inhibitor, to gemcitabine and Abraxane chemotherapy is superior to chemotherapy alone in advanced pancreatic cancer.
  • With 21 of 55 enrolled patients still on study, researchers anticipate additional partial responses may be observed before final data readout expected in mid-Q3 2025.

ACCENT: AMP945 in Combination with Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer

NCT05355298Active, Not RecruitingPhase 1
Amplia Therapeutics Limited
Posted 5/31/2022

Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression

OncologyTargeted TherapyDrug Approval
  • The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
  • All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
  • The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

NCT02099058Active, Not RecruitingPhase 1
AbbVie
Posted 1/15/2014

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

Heidelberg Pharma Initiates Phase I Trial of HDP-102 for Non-Hodgkin Lymphoma as Second Amanitin-Based ADC Enters Clinic

Oncology
  • Heidelberg Pharma has dosed the first patient with HDP-102, an amanitin-based antibody-drug conjugate targeting CD37, in a Phase I study for relapsed or refractory non-Hodgkin lymphoma.
  • The multicenter trial will evaluate safety, tolerability, and pharmacokinetics across Moldova, Israel, and selected EU countries, with plans for dose escalation followed by expansion phases.
  • HDP-102 represents the company's second ATAC technology candidate to reach clinical development, following encouraging safety and efficacy data from HDP-101 in multiple myeloma.
  • Non-Hodgkin lymphoma affects over 550,000 new patients annually, with conventional chemotherapy achieving response rates above 50% but frequent relapses highlighting the need for more durable treatments.

Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial

OncologyTargeted Therapy
  • A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses.
  • At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment.
  • The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.

Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma

NCT03770416CompletedPhase 2
M.D. Anderson Cancer Center
Posted 2/15/2019

Merck KGaA Joins Peregrine Ventures' Incentive Incubator as Strategic Partner

NeurologyOncology
  • Merck KGaA has become a strategic partner in Peregrine Ventures' Incentive Incubator, gaining early access to startups in bioconvergence, pharma, and biotechnology fields.
  • The collaboration will focus on ventures with significant market potential aligned with Merck's three global divisions: Healthcare, Life Science, and Electronics, with priority given to bioconvergence ventures.
  • Through this partnership, eligible startups will receive support including investments, regulatory guidance, business development assistance, and potentially early-phase trial planning.

Exelixis Initiates Phase 1 Trial of XB628, a Novel Bispecific NK Cell Engager for Advanced Solid Tumors

Oncology
  • Exelixis has begun dose-escalation in a first-in-human Phase 1 trial of XB628, a first-in-class bispecific antibody targeting both NKG2A and PD-L1 in patients with recurrent advanced or metastatic solid tumors.
  • XB628 represents a novel immunotherapy approach by engaging natural killer cells through dual targeting of an inhibitory receptor (NKG2A) and the immune checkpoint protein PD-L1.
  • The investigational therapy was developed through a collaboration between Exelixis and Invenra, leveraging Invenra's proprietary B-Body® platform for creating multispecific antibodies with superior biophysical properties.

Navigating Advanced Endometrial Cancer Treatment: Expert Guidance for Community Oncologists

Oncology
  • Personalized treatment plans that consider both clinical evidence and individual patient circumstances are essential for managing advanced endometrial cancer patients undergoing immuno-oncology therapy.
  • Community oncologists face significant challenges with insurance approvals for newer therapies, particularly for immunotherapies that may be considered off-label or have prohibitive costs for patients.
  • Effective patient management requires staying updated on emerging therapies, regular assessment of treatment response, prompt management of adverse effects, and involvement of multidisciplinary teams.

Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

OncologyMonoclonal AntibodyLeadership Change
  • Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.
  • The appointment comes as Syndax continues to expand its portfolio, which includes FDA-approved Revuforj (menin inhibitor) and Niktimvo (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor.
  • Dr. Botwood succeeds Dr. Neil Gallagher, who oversaw multiple positive data readouts, two product approvals, and the recent submission of Revuforj's supplemental New Drug Application for relapsed or refractory mNPM1 acute myeloid leukemia.

First U.S. Patient Successfully Treated with Advanced Proton Arc Therapy for Rare Cancer

Oncology
  • A 46-year-old patient with adenoid cystic carcinoma became the first in the U.S. to receive step-and-shoot proton arc therapy, experiencing minimal side effects despite the cancer's invasion of nerves leading to her brain.
  • The groundbreaking radiation technique delivers treatment more precisely and continuously than conventional methods, significantly reducing damage to surrounding healthy tissue and allowing the patient to maintain normal daily activities throughout treatment.
  • Researchers at Corewell Health are already developing the next generation of this technology, called DynamicARC®, which promises even more precise targeting with no lag time between radiation doses and is expected to receive FDA approval next year.

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