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Non-Histone Lactylation Emerges as Key Regulator in Cancer Progression and Therapeutic Target

Targeted Therapy
  • Non-histone lactylation, a novel post-translational modification, plays critical roles in cancer progression by modulating protein stability, enzyme activity, and cellular signaling pathways beyond traditional histone modifications.
  • Research reveals that lactylation affects diverse biological processes including cardiovascular diseases, neurological disorders, immune responses, and particularly cancer development through mechanisms like DNA damage repair and tumor microenvironment modulation.
  • Multiple enzymes including P300, KAT8, AARS1, and AARS2 function as lactylation "writers," while HDACs and sirtuins serve as "erasers," creating a dynamic regulatory system that influences disease pathogenesis.
  • Therapeutic strategies targeting lactylation pathways show promise, with small molecule inhibitors and specific blockers demonstrating potential to overcome drug resistance and enhance cancer treatment efficacy.

Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy

Precision MedicineOncologyDrug ApprovalTargeted Therapy
  • Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
  • The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
  • This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.

Aktis Oncology's First-in-Class Nectin-4 Radiopharmaceutical AKY-1189 Shows Promising Tumor Uptake Across Multiple Cancer Types

Targeted TherapyOncology
  • Aktis Oncology's AKY-1189, the industry's only Nectin-4-directed radioligand therapy, demonstrated significant tumor uptake across multiple solid tumor types in first human data from 15 evaluable patients.
  • The novel miniprotein radiopharmaceutical showed excellent uptake in ER-positive breast cancer and bladder cancer, with potential applications beyond current Nectin-4 therapy Padcev.
  • Dosimetry analysis in eight patients revealed a wide therapeutic index with transient kidney uptake and no treatment-emergent adverse events, supporting progression to formal clinical trials.
  • The company is preparing to initiate phase 1 studies in South Africa and the US in 2025, following a recent $60 million deal with Lilly and $175 million Series B financing.

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma

Targeted TherapyOncologyMonoclonal Antibody
  • NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
  • The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
  • At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.

FDA Grants Accelerated Approval to Krazati Plus Cetuximab for KRAS G12C-Mutated Colorectal Cancer

Drug ApprovalPrecision MedicineTargeted Therapy
  • The FDA granted accelerated approval to Krazati (adagrasib) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior standard chemotherapy treatments.
  • The combination therapy targets a specific genetic mutation and is approved for patients whose tumors are determined to have the KRAS G12C mutation by an FDA-approved test.
  • The most common adverse reactions include rash, nausea, diarrhea, vomiting, fatigue, and musculoskeletal pain, occurring in at least 20% of patients.
  • This approval represents a significant advancement in precision medicine for colorectal cancer patients with this specific genetic alteration.

Combination Immunotherapy Strategies Show Promise in Overcoming NSCLC Treatment Resistance

Targeted Therapy
  • Combination immunotherapies demonstrate superior efficacy compared to monotherapy approaches in NSCLC, with dual checkpoint inhibition and chemo-immunotherapy combinations showing improved overall survival and progression-free survival rates.
  • Multiple resistance mechanisms to targeted therapies and immunotherapy have been identified in NSCLC, including target-dependent mutations, bypass pathway activation, and tumor microenvironment changes that limit treatment effectiveness.
  • Novel therapeutic strategies including fourth-generation EGFR-TKIs, antibody-drug conjugates, and combination approaches targeting multiple pathways are being developed to overcome resistance mechanisms.
  • Biomarker-driven patient selection and personalized treatment approaches are emerging as critical factors for optimizing combination therapy outcomes in NSCLC patients.

Merck Launches Phase 3 Trial of MK-1084 Plus Pembrolizumab for KRAS G12C-Mutated NSCLC

Targeted Therapy
  • Merck has initiated a phase 3 trial evaluating MK-1084, an investigational oral KRAS G12C inhibitor, in combination with pembrolizumab as first-line treatment for metastatic NSCLC patients with KRAS G12C mutations and PD-L1 expression ≥50%.
  • The double-blind, multicenter trial will enroll approximately 600 patients globally, with primary endpoints of progression-free survival and overall survival.
  • Phase 1 data showed promising efficacy with a 47% overall response rate for the combination therapy compared to 19% for MK-1084 monotherapy.
  • KRAS G12C is the most common KRAS mutation in NSCLC patients, occurring in approximately 14% of adenocarcinomas, representing a significant unmet medical need.

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

NCT06136650RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/18/2023

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

NCT06074588RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/12/2023

A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)

NCT06345729RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/24/2024

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

NCT06079879RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2023

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

NCT06170788RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/15/2023

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

NCT06136624Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2023

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

NCT06136559RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/13/2023

A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

NCT05067283RecruitingPhase 1
Merck Sharp & Dohme LLC
Posted 12/17/2021

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

NCT06132958RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/6/2023

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

NCT05624554Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/16/2023

Merck and Daiichi Sankyo Form $22 Billion Alliance for Three Novel Antibody-Drug Conjugates

OncologyTargeted TherapyPrecision Medicine
• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion.
• The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors.
• Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

NCT04707248Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 12/22/2020

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

OncologyTargeted TherapyPrecision Medicine
  • Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
  • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
  • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

NCT03363893CompletedPhase 1
Carrick Therapeutics Limited
Posted 11/14/2017

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