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Targeted Therapies Transform Biliary Tract Cancer Treatment Landscape with FGFR2 Inhibitors Leading Clinical Advances

Targeted TherapyPrecision MedicineOncology
  • Biliary tract cancer treatment has evolved from traditional cytotoxic chemotherapy to include targeted therapies based on specific molecular alterations, with FGFR2 inhibitors showing particularly promising results.
  • Pemigatinib and futibatinib, selective FGFR inhibitors, have demonstrated significant clinical efficacy with response rates of 35% and 42% respectively in patients with FGFR2 fusions.
  • Comprehensive next-generation sequencing has become the standard approach for identifying actionable molecular alterations, with IDH1/2 mutations, FGFR2 fusions, and ERBB2 alterations being the most clinically significant biomarkers.
  • The rarity of biliary tract cancers presents unique challenges in treatment access, making clinical trials essential for patients with molecular alterations that have FDA-approved therapies in other disease states.

Australian-First "Seek-and-Destroy" Cancer Therapy Begins Human Trials Targeting CDCP1 Protein

Targeted Therapy
  • A groundbreaking radioactive therapy targeting the CDCP1 protein in cancer cells has begun its first human trial in Australia, with a 69-year-old Brisbane woman becoming the first patient to receive the treatment.
  • The therapy, developed over 24 years by Professor John Hooper, uses an innovative antibody that binds to CDCP1 found in ovarian, bladder, and other common cancers to deliver targeted radiotherapy.
  • Up to 45 patients with ovarian and bladder cancer will participate in the trial, which aims to provide exceptionally accurate imaging of metastasizing cancer and potentially become the gold standard treatment for multiple cancer types.
  • The research represents a collaboration between Mater Research, The University of Queensland, CSIRO, and other institutions, with ovarian cancer having a five-year survival rate of just 49 percent.

Arvinas CEO John Houston Announces Retirement Following PROTAC Breakthrough Success

Leadership ChangeTargeted Therapy
  • John Houston, Ph.D., CEO and President of Arvinas, announces plans to retire from executive roles after eight years of leadership, while remaining as Board Chairperson.
  • Under Houston's leadership, Arvinas achieved multiple industry firsts for PROTAC protein degraders, including the first positive pivotal Phase 3 trial and first new drug application.
  • The company has advanced six PROTAC programs into clinical trials and demonstrated for the first time that orally administered PROTACs can achieve pharmacodynamic activity in the central nervous system.
  • Arvinas Board of Directors has initiated a search for Houston's successor to continue advancing the company's targeted protein degradation platform across multiple therapeutic areas.

Comprehensive Genomic Profiling Emerges as Essential Standard for Personalized Cancer Treatment

Precision MedicineTargeted Therapy
  • Comprehensive genomic profiling has become standard practice for non-small cell lung cancer treatment, enabling identification of actionable genomic alterations that guide personalized therapeutic decisions.
  • The integration of both tissue-based testing and plasma-based next-generation sequencing provides complementary molecular profiling capabilities throughout the patient care continuum.
  • Incomplete genomic testing can leave patients without access to potentially beneficial targeted therapies, emphasizing the critical importance of comprehensive molecular profiling for optimal outcomes.
  • Future applications include expanded serial testing for resistance monitoring and potential expansion into earlier cancer stages as precision medicine approaches continue evolving.

Revolution Medicines Partners with Iambic Therapeutics in $25M AI-Driven Drug Discovery Collaboration for RAS-Addicted Cancers

AIDrug DiscoveryOncologyTargeted Therapy
  • Revolution Medicines and Iambic Therapeutics announced a multi-year collaboration in July 2025 to develop novel drug candidates using AI-driven discovery platforms targeting RAS-addicted cancers.
  • The partnership leverages Iambic's NeuralPLexer protein structure prediction model and PropANE neural network, trained on Revolution's proprietary data to accelerate discovery of therapies for challenging oncology targets.
  • Under the agreement, Iambic will receive up to $25 million through upfront payments, performance-based milestones, and R&D reimbursements, while both companies retain rights to exclusive targets.
  • The collaboration aims to address RAS mutations that drive approximately 30% of all cancers but remain among the most challenging drug targets for conventional discovery methods.

Quebec Expands Public Reimbursement of Pluvicto Radioligand Therapy for Advanced Prostate Cancer

Targeted TherapyPrecision Medicine
  • Quebec implemented public reimbursement of Pluvicto (lutetium-177 vipivotide tetraxetan) as of July 2, 2025, for eligible patients with PSMA-positive metastatic castration-resistant prostate cancer.
  • The radioligand therapy is now publicly funded in Canada's four most populous provinces, significantly expanding access to this precision cancer treatment for patients who have undergone prior androgen receptor pathway inhibition and taxane-based chemotherapy.
  • Pluvicto represents the first targeted radioligand therapy approved by Health Canada for PSMA-positive mCRPC, combining a targeting compound with a therapeutic radioisotope to deliver targeted radiation to cancer cells.
  • Healthcare leaders emphasize this milestone closes a longstanding treatment gap and provides new hope for patients with advanced prostate cancer who have exhausted multiple treatment lines.

RDP Pharma and Singapore's EDDC Partner to Develop Protein Degrader Therapies for Autoimmune Diseases

Drug DiscoveryTargeted Therapy
  • Swiss biotechnology company RDP Pharma AG has formed a strategic research collaboration with Singapore's Experimental Drug Development Centre (EDDC) to develop monovalent targeted protein degraders for autoimmune diseases.
  • The partnership combines RDP Pharma's proprietary PromptDegrader™ platform with EDDC's integrated drug discovery capabilities to create oral therapeutics targeting dysfunctional immune responses.
  • Global autoimmune disease incidence is rising with annual increases of 19.1% and 12.5% respectively, highlighting the urgent need for new therapeutic options with improved efficacy and fewer side effects.
  • The collaboration aims to address unmet medical needs for patients with chronic autoimmune conditions including rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.

Avacta Strengthens Leadership Team with Appointment of Chief Medical Officer and Business Development Advisor

OncologyTargeted Therapy
  • Avacta Group plc has appointed David Liebowitz, M.D., Ph.D. as Chief Medical Officer to lead clinical strategy and execution for its targeted cancer therapy pipeline.
  • Liebowitz brings over 30 years of experience in oncology drug development and has contributed to more than 25 Investigational New Drug applications throughout his career.
  • The company also appointed Yulii Bogatyrenko as business development advisor to strengthen corporate growth strategy and pipeline advancement.
  • These appointments come at a pivotal time as Avacta continues to advance its pre|CISION platform for targeted oncology drug delivery.

Revolution Medicines and Summit Therapeutics Launch Clinical Collaboration to Test RAS Inhibitor Combinations with Bispecific Antibody

Targeted Therapy
  • Revolution Medicines and Summit Therapeutics announced a clinical collaboration to evaluate three RAS(ON) inhibitors in combination with ivonescimab, a PD-1/VEGF bispecific antibody, across multiple solid tumor types.
  • The collaboration will test combinations in RAS mutant non-small cell lung cancer, pancreatic ductal adenocarcinoma, and colorectal cancer, with Revolution Medicines serving as study sponsor.
  • Revolution Medicines has previously disclosed promising initial evidence that daraxonrasib and elironrasib can deliver additive antitumor activity safely when combined with PD-1 antibodies in first-line RAS mutant NSCLC treatment.

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

Monoclonal AntibodyTargeted TherapyOncology
  • Amgen's Phase 3 FORTITUDE-101 trial met its primary endpoint, demonstrating that bemarituzumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with FGFR2b-positive gastric cancer.
  • The study enrolled 547 patients across 300 sites in 37 countries, targeting those with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who were non-HER2 positive.
  • Bemarituzumab represents the first positive Phase 3 results for an FGFR2b-targeted monoclonal antibody in gastric cancer, addressing a critical unmet need in a disease that causes over 650,000 deaths globally each year.
  • While the treatment showed efficacy, ocular adverse events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience.

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

NCT05111626Active, Not RecruitingPhase 3
Amgen
Posted 3/14/2022

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT05052801Active, Not RecruitingPhase 3
Amgen
Posted 3/7/2022
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