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RET Inhibitor Rechallenge Shows Promise in Pre-Treated NSCLC Patients After Toxicity-Related Discontinuation

Targeted TherapyOncology
  • Rechallenge with a different first-generation RET inhibitor after toxicity-related discontinuation achieved a 50% objective response rate and 9.89-month median progression-free survival in RET-rearranged NSCLC patients.
  • The retrospective multicenter study from the RET MAP registry demonstrated that switching to a different RET inhibitor of the same class remains effective after initial treatment discontinuation due to side effects.
  • RET inhibitor rechallenge after disease progression showed limited efficacy as monotherapy with only 18% response rate, though combination therapies targeting bypass resistance showed some promise.
  • The findings provide new evidence for treatment sequencing in RET-rearranged NSCLC, a rare subset affecting 1-2% of advanced lung cancer patients with limited therapeutic options.

Continuity Biosciences Acquires Focal Medical to Advance Iontophoresis-Based Pancreatic Cancer Therapy

Targeted Therapy
  • Continuity Biosciences has acquired Focal Medical, a North Carolina-based company developing site-specific chemotherapy using iontophoresis technology for pancreatic cancer treatment.
  • Focal Medical's lead product candidate uses an iontophoresis device to deliver gemcitabine directly to pancreatic tumors, which has received FDA IND clearance with Phase 1b trials expected to begin later this year.
  • The acquisition includes Focal Medical's patent estate, technology platform, and a dedicated R&D facility in Cary, NC, positioning Continuity as a leader in device-targeted therapeutics for solid tumors.
  • The iontophoresis approach enhances local drug concentration while minimizing systemic toxicity, addressing key limitations of traditional gemcitabine administration in pancreatic cancer.

Phase 3 Trial Shows Promise for Adjuvant BRAF/MEK Inhibitor Combination in High-Risk Melanoma

Targeted TherapyOncology
  • The phase 3 EORTC-2139-MG/Columbus-AD trial demonstrated that adjuvant encorafenib plus binimetinib improved 12-month recurrence-free survival to 86% versus 70% with placebo in patients with stage IIB/C BRAF V600-mutant melanoma.
  • The combination therapy was generally well tolerated with a manageable safety profile, though 33% of patients discontinued treatment due to adverse events.
  • This represents the first randomized adjuvant trial of BRAF-directed therapy in stage IIB/IIC melanoma, potentially offering patients an alternative to immunotherapy in the adjuvant setting.

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

NCT01909453CompletedPhase 3
Pfizer
Posted 9/12/2013

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

NCT05270044Active, Not RecruitingPhase 3
Pierre Fabre Medicament
Posted 5/2/2022

Terbium-161 Radioimmunotherapy Shows Superior Efficacy Against Lymphoma in Preclinical Studies

Targeted TherapyMonoclonal AntibodyOncology
  • Researchers at the Paul Scherrer Institute have developed a novel radioimmunotherapy using terbium-161 attached to CD30-targeting antibodies for lymphoma treatment.
  • The terbium-161 therapy demonstrated 2 to 43 times greater cancer cell killing efficacy compared to lutetium-177 in laboratory studies.
  • Preclinical mouse studies showed treated animals survived twice as long as controls, with some achieving complete cancer remission.
  • The therapy targets CD30 receptors present in approximately one-third of lymphoma patients and could address previously difficult-to-treat T-cell lymphomas.

Novel Antibody-Drug Conjugate Achieves 85% Response Rate in Rare Blood Cancer Trial

Targeted TherapyPrecision Medicine
  • Pivekimab sunirine (PVEK), a first-in-class antibody-drug conjugate, demonstrated an 85% overall response rate and 70% complete response rate as frontline treatment for newly diagnosed BPDCN patients.
  • The Phase I/II CADENZA trial enrolled 84 patients with CD123-positive blastic plasmacytoid dendritic cell neoplasm, showing a median overall survival of 16.6 months in the frontline cohort.
  • PVEK targets CD123 receptors highly expressed on BPDCN cells and showed manageable safety profile with peripheral edema as the most common reversible side effect.
  • Researchers suggest PVEK should be considered as a new standard-of-care treatment for this rare, aggressive blood cancer that affects bone marrow, skin, and lymph nodes.

RLY-2608 Shows Promise in PIK3CA-Mutant Breast Cancer with Improved Tolerability Profile

Targeted Therapy
  • RLY-2608, a mutant-selective PI3Kα inhibitor, combined with fulvestrant achieved a 38.7% overall response rate and 10.3-month median progression-free survival in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer.
  • The combination demonstrated superior tolerability compared to existing PI3K inhibitors, with predominantly low-grade hyperglycemia and significantly reduced rates of diarrhea, rash, and oral sores.
  • Based on these promising phase 1 results, RLY-2608 plus fulvestrant will advance to a pivotal phase 3 trial in 2025, comparing against the current standard of care capivasertib plus fulvestrant.
  • Patients with kinase domain PIK3CA mutations showed particularly impressive outcomes, achieving a 66.7% response rate and 18.4-month median progression-free survival.

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

NCT05216432RecruitingPhase 1
Relay Therapeutics, Inc.
Posted 12/8/2021

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521Not Yet RecruitingPhase 3
Relay Therapeutics, Inc.
Posted 7/31/2025

ALNEO Trial Demonstrates Promising Perioperative Alectinib Activity in Stage III ALK-Positive NSCLC

Targeted Therapy
  • The phase II ALNEO trial achieved its primary endpoint, demonstrating a 46% major pathological response rate with neoadjuvant alectinib in 33 patients with potentially resectable stage III ALK-positive NSCLC.
  • Among 28 patients who underwent surgery, 86% achieved R0 resection with no residual microscopic tumor, and 48% experienced nodal downstaging following neoadjuvant treatment.
  • This represents the first prospective trial evaluating targeted therapy in the perioperative setting for locally advanced ALK-positive NSCLC, offering a potential alternative to cytotoxic chemotherapy.
  • Treatment was well-tolerated with only 9% of patients experiencing grade 3 or higher adverse events during neoadjuvant therapy and no grade 4/5 treatment-related serious adverse events observed.

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

NCT05015010Active, Not RecruitingPhase 2
Gruppo Oncologico Italiano di Ricerca Clinica
Posted 5/20/2021

ASP Isotopes and Isotopia Forge Strategic Partnership to Accelerate Terbium-161 Cancer Therapy Production

Targeted Therapy
  • ASP Isotopes and Isotopia have entered a four-year supply agreement for enriched Gadolinium-160, addressing critical supply bottlenecks for Terbium-161 production starting in 2026.
  • The partnership leverages ASP's Quantum Enrichment technology to enable Isotopia's advancement of Tb-161-based targeted radiotherapies for prostate cancer and neuroendocrine tumors.
  • Terbium-161's dual mechanism of action, including Auger electron emissions, offers precise targeting of micro-metastases while minimizing damage to healthy tissues.
  • The collaboration positions both companies at the forefront of the radiopharmaceutical revolution with potential to expand cancer treatment options worldwide.

InxMed Reports Breakthrough Results for Ifebemtinib-Garsorasib Combination in KRAS G12C-Mutant Cancers at ASCO 2025

Targeted Therapy
  • InxMed's Phase Ib/II trial data shows ifebemtinib plus garsorasib achieved a median progression-free survival of 22.3 months in first-line NSCLC patients with KRAS G12C mutations.
  • The dual-oral combination demonstrated superior efficacy in colorectal cancer, with objective response rates of 44.4% versus 16.7% for garsorasib monotherapy.
  • The chemotherapy-free regimen showed consistent efficacy regardless of PD-L1 expression status and has prompted initiation of a Phase III pivotal trial.
  • Ifebemtinib has received Breakthrough Therapy Designation from China's NMPA and Fast-Track Designation from the FDA, with regulatory submission planned for 2025.

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

NCT05379946Active, Not RecruitingPhase 1
InventisBio Co., Ltd
Posted 10/12/2022

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

NCT06166836RecruitingPhase 1
InxMed (Shanghai) Co., Ltd.
Posted 10/12/2022

Genor Biopharma Secures NMPA Approval for Lerociclib CDK4/6 Inhibitor in Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • Genor Biopharma Holdings Ltd. received China National Medical Products Administration (NMPA) approval for Lerociclib (GB491), a novel CDK4/6 inhibitor for advanced breast cancer treatment.
  • The oral bioavailable drug targets hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in adult patients.
  • Lerociclib will be used in combination with aromatase inhibitors as initial therapy or with fulvestrant following endocrine therapy progression.
  • The approval represents a significant milestone resulting from successful collaboration between Genor Biopharma and G1 Therapeutics Inc.
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