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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 Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or 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

NCT06982521RecruitingPhase 3
Relay Therapeutics, Inc.
Posted 8/26/2025

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.

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

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

AstraZeneca Advances AZD0022, Novel Oral KRASG12D Inhibitor, in First-in-Human Phase I/IIa Trial

Monoclonal AntibodyTargeted TherapyOncology
  • AstraZeneca is developing AZD0022, a potent oral KRASG12D-selective inhibitor that demonstrates robust pathway inhibition and anti-tumor activity in preclinical models.
  • The drug is currently being investigated in the ALAFOSS-01 study, a first-in-human Phase I/IIa trial for patients with KRASG12D-mutated solid tumors.
  • Preclinical data shows enhanced therapeutic responses when AZD0022 is combined with cetuximab, with sustained tumor regressions observed in colorectal and pancreatic cancer models.
  • The clinical trial includes both monotherapy and combination therapy modules, targeting multiple cancer types including colorectal, lung, and pancreatic cancers.

A trial to learn how safe AZD0022 is, how well it works, and how it moves throughout the body over time in adults with tumors that have a KRAS-G12D mutation, when given alone and with other cancer drugs

2024-516699-14-00RecruitingPhase 1/2
AstraZeneca AB
Posted 10/18/2024

Pancreatic Cancer Pipeline Expands with 80+ Companies Advancing Novel Therapies

Targeted TherapyMonoclonal Antibody
  • DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment.
  • Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches.
  • Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer.
  • Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.

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.

FDA Clears Phase 1b Trial for Novel Nectin-4 Targeted Radiopharmaceutical AKY-1189 Across Multiple Cancer Types

Targeted Therapy
  • The FDA has cleared investigational new drug applications for Aktis Oncology's AKY-1189, a first-in-class Nectin-4 targeted radiopharmaceutical, enabling initiation of the NECTINIUM-2 Phase 1b trial.
  • The multicenter trial will evaluate AKY-1189 in approximately 150 patients with locally advanced or metastatic urothelial carcinoma, triple negative breast cancer, and other Nectin-4 expressing solid tumors.
  • Previous data demonstrated substantial tumor uptake across multiple cancer types with limited normal tissue exposure, suggesting a potentially wide therapeutic window for this precision oncology approach.

TTF-1 Biomarker Predicts Survival Outcomes for KRAS Inhibitor Sotorasib in Lung Cancer

Targeted TherapyPrecision Medicine
  • MD Anderson researchers identified TTF-1 as a predictive biomarker for survival outcomes in advanced KRAS G12C-mutated non-small cell lung cancer patients treated with sotorasib.
  • Patients with high TTF-1 expression achieved significantly better outcomes with median progression-free survival of 8.1 months versus 2.8 months for low TTF-1 expression.
  • The study analyzed 429 patients from CodeBreaK clinical trials and found that rapid circulating tumor DNA clearance was linked to improved treatment response.
  • TTF-1 testing is already routinely performed in lung cancer diagnosis, providing physicians an immediate tool to personalize sotorasib treatment decisions.

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