MedPath

Tagged News

Precision Medicine Oncology Pharmacists Emerge as Critical Players in Personalized Cancer Care

Precision MedicineTargeted Therapy
  • Precision medicine oncology pharmacists have become essential members of multidisciplinary cancer care teams, contributing to targeted therapy selection, molecular tumor board discussions, and patient access to novel drug combinations.
  • These specialized pharmacists address significant barriers to precision oncology implementation, including complex medication access pathways, insurance restrictions, and the need for comprehensive patient education on oral anticancer medications.
  • Despite the expanding role of pharmacists in precision medicine, up to 70% remain unaware of institutional precision medicine initiatives, highlighting the need for increased training and institutional support to fully realize their potential in personalized cancer care.

BrightSpring's Onco360 Pharmacy Selected as National Partner for Three New Cancer and Rare Disease Therapies

OncologyRare DiseaseDrug ApprovalTargeted Therapy
  • BrightSpring Health Services announced that its specialty pharmacy Onco360 has been selected as the national pharmacy partner for three newly approved therapies targeting advanced cancers and rare genetic disorders.
  • The partnership includes GOMEKLI for neurofibromatosis type 1 patients with plexiform neurofibromas, AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, and IBTROZI for ROS1-positive non-small cell lung cancer.
  • Onco360 will provide comprehensive patient support including access, education, data management, and expert clinical guidance for these innovative treatments across all 50 states.

Curasight Advances uTREAT Brain Cancer Therapy with Phase 1 Trial Submission to EMA

Targeted Therapy
  • Curasight A/S has submitted a Clinical Trial Application to the European Medicines Agency for a Phase 1 trial of uTREAT, a targeted radiopharmaceutical therapy for glioblastoma patients.
  • The therapy targets the uPAR receptor, with recent Phase II data showing 94% of Grade 4 gliomas were uPAR-positive, supporting the treatment's potential in this aggressive brain cancer.
  • Glioblastoma affects approximately 30,000 patients annually in the US and EU, with a devastating prognosis where only 5% of patients survive five years after diagnosis.
  • The company has partnered with Premier Research as the contract research organization to conduct the international Phase 1 trial, with first patient dosing expected in the second half of 2025.

Lung Cancer Research Foundation and Boehringer Ingelheim Launch $2.25 Million Initiative to Target HER2-Mutant Lung Cancer

Targeted Therapy
  • The Lung Cancer Research Foundation and Boehringer Ingelheim announced a $2.25 million research collaboration to advance understanding and treatment of HER2-mutant lung cancer through two new funding mechanisms.
  • The initiative includes a $1.5 million Team Science Award and $750,000 in Early Career Investigator Awards, addressing the critical need for novel therapeutic approaches in HER2-driven lung cancers.
  • HER2 mutations occur in up to 4% of non-small cell lung cancer cases, with current treatments not being curative and resistance invariably developing despite recent FDA approval of trastuzumab deruxtecan.
  • The collaboration aims to accelerate scientific discovery by supporting team-based research approaches and early career investigators, with proposal submissions due by July 29, 2025.

Shasqi Achieves First-in-Human Success with Click Chemistry Cancer Therapy, Delivering 12-Fold Higher Doxorubicin Doses

Targeted Therapy
  • Shasqi has published landmark results from the first-in-human clinical trial of SQ3370, marking the inaugural use of click chemistry-based cancer therapeutics in patients with advanced solid tumors.
  • The company's CAPAC® platform enabled delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches while reducing systemic toxicity and myelosuppression.
  • The breakthrough demonstrates that click chemistry can be safely harnessed inside the human body to concentrate cancer drugs at tumor sites while sparing healthy tissues.
  • Nobel Prize winner Carolyn Bertozzi emphasized that this study unlocks a new frontier for oncology innovation by proving biorthogonal chemical groups are tolerated in humans.

Debiopharm Initiates First-in-Human Trial of CD37-Targeted ADC Debio 1562M for Relapsed/Refractory AML

Monoclonal AntibodyOncologyTargeted Therapy
  • Debiopharm has dosed the first patient in a Phase 1/2 trial of Debio 1562M, a first-in-class CD37-targeted antibody-drug conjugate for relapsed/refractory acute myeloid leukemia patients.
  • The compound utilizes Debiopharm's proprietary Trifecta approach, combining naratuximab antibody, MultiLink™ linker technology, and a microtubule inhibitor payload to target CD37 antigens on leukemic cells.
  • AML represents a significant unmet medical need with only 32% five-year overall survival and median survival as low as 7 months in certain populations.
  • Preclinical studies demonstrated Debio 1562M showed anti-leukemic activity across all AML subtypes and superior activity compared to current standard-of-care therapies.

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430RecruitingPhase 1
Debiopharm International SA
Posted 5/30/2025

Pierre Fabre Acquires Global Rights to Next-Generation EGFR Inhibitors for NSCLC Treatment

Targeted TherapyPrecision MedicineOncology
  • Pierre Fabre Laboratories acquired worldwide rights to PFL-721 and PFL-241 from Antares Therapeutics, expanding their oncology pipeline with mutant-specific EGFR inhibitors targeting unmet needs in non-small cell lung cancer.
  • PFL-721 is a dual EGFR exon 20 and HER2 exon 20 inhibitor transitioning to dose optimization in first-in-human trials, while PFL-241 is a brain-penetrant fourth-generation EGFR inhibitor addressing C797S resistance mutations.
  • EGFR mutations drive approximately 14-38% of NSCLC tumors globally, representing a significant patient population with substantial therapeutic needs.
  • The acquisition consolidates Pierre Fabre's complete ownership of their R&D portfolio including exarafenib and PFL-002, positioning the company to advance precision medicine development for cancer patients.

UK Flair Trial Demonstrates Superior Outcomes with Chemotherapy-Free Combination Therapy for Chronic Lymphocytic Leukaemia

Targeted Therapy
  • The UK-wide Flair trial involving 786 patients showed that 94% of chronic lymphocytic leukaemia patients receiving ibrutinib plus venetoclax were alive with no disease progression after five years, compared to 79% on ibrutinib alone and 58% on standard chemotherapy.
  • The chemotherapy-free combination therapy achieved superior bone marrow clearance rates, with 66% of patients showing no detectable cancer after two years versus 48% on chemotherapy and none on ibrutinib monotherapy.
  • Researchers from Leeds Teaching Hospitals described the results as a "milestone" that could reshape treatment approaches for the most common adult leukaemia, offering more effective and tolerable personalized medicine options.

Novel BTK Degrader BGB-16673 Achieves 84.8% Response Rate in Heavily Pretreated CLL/SLL Patients

Targeted Therapy
  • BGB-16673, a novel BTK protein degrader, demonstrated an 84.8% overall response rate in 66 heavily pretreated patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma in the phase 1/2 CaDAnCe-101 trial.
  • The treatment showed efficacy across high-risk patient subgroups, including those with BTK mutations and prior exposure to multiple BTK and BCL2 inhibitors, with responses observed regardless of baseline mutations and unfavorable biological features.
  • At a median follow-up of 15.6 months, the drug was well-tolerated with manageable safety profile, and achieved a one-year progression-free survival rate of 77.4% in this challenging patient population.
  • The 200-mg dose level, selected for expansion, showed particularly promising results with a 93.8% overall response rate and median duration of exposure of 16.2 months.

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716RecruitingPhase 1
BeiGene
Posted 9/13/2021

ITM to Present Phase 3 COMPETE Trial Data at SNMMI 2025 Meeting

Targeted Therapy
  • ITM Isotope Technologies Munich will present further analysis from its successful Phase 3 COMPETE trial at the SNMMI 2025 annual meeting in New Orleans from June 21-24.
  • The COMPETE trial demonstrated that 177Lu-edotreotide (ITM-11) achieved clinically and statistically significant improvement in progression-free survival compared to everolimus in patients with gastroenteropancreatic neuroendocrine tumors.
  • Dr. Thomas Hope will deliver an oral presentation on predicting tumor uptake using pre-therapeutic imaging, while a satellite symposium will cover the broader treatment landscape and dosimetry evolution.
  • The company will also showcase its radiopharmaceutical therapy pipeline and capabilities at booth 1001 during the conference.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.