MedPath

Tagged News

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.

NHS Becomes First Health System Globally to Approve 'Trojan Horse' Cancer Therapy for Multiple Myeloma

Drug ApprovalTargeted TherapyOncology
  • The NHS in England has become the first health system worldwide to approve belantamab mafodotin (Blenrep), a novel antibody-drug conjugate therapy for multiple myeloma patients.
  • Clinical trials demonstrated the treatment delayed disease progression by an average of three years compared to just over one year with standard daratumumab therapy.
  • Approximately 1,500 patients annually with relapsed or refractory multiple myeloma will be eligible for this targeted therapy through the NHS Cancer Drugs Fund.
  • The "Trojan horse" mechanism allows the drug to infiltrate cancer cells and release lethal molecules from within, representing a significant advancement in myeloma treatment.

Tazemetostat-Pinometostat Combination Shows Promise for B-Cell Lymphoma Treatment Resistance

Targeted Therapy
  • Researchers at The Institute of Cancer Research, London, have demonstrated that combining tazemetostat with DOT1L inhibitor pinometostat can overcome treatment resistance in B-cell lymphoma patients.
  • The drug combination significantly shrunk tumors in preclinical models, with treated tumors shrinking while control tumors tripled in size after 15 days.
  • The combination therapy could potentially benefit thousands of patients with diffuse large B-cell lymphoma, the most common type affecting around 5,000 UK patients annually.
  • Clinical trials are anticipated to test this dual-targeting approach that combines EZH2 and DOT1L inhibition to overcome cancer's drug resistance mechanisms.

Johnson & Johnson's Bleximenib Shows Promising Results in Phase 1b AML Trial with 82% Response Rate

Targeted Therapy
  • Johnson & Johnson's investigational menin inhibitor bleximenib demonstrated an 82% overall response rate in relapsed/refractory AML patients when combined with venetoclax and azacitidine in Phase 1b trials.
  • The combination therapy showed a favorable safety profile with only 4% of patients experiencing differentiation syndrome and no cardiac safety signals at the recommended Phase 2 dose.
  • Bleximenib targets AML patients with KMT2A gene rearrangements or NPM1 mutations, representing genetically defined subpopulations with particularly poor prognoses and limited treatment options.

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

NCT05453903RecruitingPhase 1
Janssen Research & Development, LLC
Posted 10/4/2022

Toripalimab Emerges as Preferred PD-1 Inhibitor for Metastatic Nasopharyngeal Carcinoma Despite Access Challenges

CAR-TTargeted Therapy
  • Toripalimab has received NCCN category 1 recommendation for nasopharyngeal carcinoma based on positive phase 3 data in both first-line and second-line settings, unlike pembrolizumab which showed negative results in the KEYNOTE-122 trial.
  • Clinical practitioners report easier insurance coverage for pembrolizumab compared to toripalimab, leading many to use pembrolizumab off-label in combination with chemotherapy despite inferior clinical evidence.
  • PD-1 inhibitors combined with chemotherapy represent the established standard of care for systemic recurrent nasopharyngeal carcinoma, with EBV levels serving as useful biomarkers for monitoring treatment efficacy.
  • Future treatment approaches may focus on novel combinations including CAR-T cell therapy, tumor-infiltrating lymphocytes, and targeted therapies like EGFR inhibitors to improve outcomes while reducing toxicity.

Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

NCT02611960CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 4/18/2016

Monopar Therapeutics Launches FDA-Authorized Expanded Access Program for uPAR-Targeted Radiopharmaceuticals in Advanced Cancers

Targeted Therapy
  • Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors.
  • The program targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancers through selective targeting of the urokinase plasminogen activator receptor (uPAR).
  • EDNOC in Houston, Texas serves as the treatment center and is among the first private outpatient facilities designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI.
  • The expanded access program follows the initiation of Phase 1 clinical trials in Australia and represents continued progress in Monopar's radiopharmaceutical pipeline development.

MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980506available
Monopar Therapeutics

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980519available
Monopar Therapeutics

Bristol Myers Squibb Acquires Novel Prostate Cancer Radiopharmaceutical for $1.35 Billion

Targeted TherapyOncology
  • Bristol Myers Squibb agreed to pay $350 million upfront to Philochem for worldwide rights to OncoACP3, an experimental radiopharmaceutical targeting the ACP3 protein for prostate cancer diagnosis and treatment.
  • OncoACP3 targets ACP3, a biomarker highly expressed in prostate cancer that potentially exceeds PSMA expression levels, offering an alternative pathway to current PSMA-targeted therapies.
  • The deal includes up to $1 billion in additional milestone payments and royalties, positioning Bristol Myers to compete with Novartis in the rapidly expanding radiopharmaceutical market.
  • RayzeBio, Bristol Myers' radiopharmaceutical subsidiary acquired for $4.1 billion, will lead development of OncoACP3 through Phase 1 therapeutic testing.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy