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Real-World Study Reveals Biomarker Status Drives Survival and Cost Disparities in Advanced NSCLC

Targeted TherapyPrecision MedicineReal World Evidence
  • A large real-world study of 26,635 advanced NSCLC patients found significant survival differences based on biomarker status, with ALK-positive patients achieving nearly 40 months median survival compared to 12-16 months for those without driver mutations.
  • Medication costs varied substantially by biomarker group, with the average annual treatment cost reaching $120,000 and two-year costs approximately $183,000 across all patients.
  • Patients without driver alterations showed consistently higher "cost per survivor" ratios, requiring about $500,000 to keep one low PD-L1 patient alive for two years versus $363,000 for ALK-positive patients.
  • The findings highlight critical gaps in community biomarker testing, where only 37% of NSCLC patients receive all nine recommended biomarker tests despite 83% having at least one test performed.

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

NCT03456076Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/16/2018

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

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

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

NCT04351555Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/16/2020

Novel BTK Inhibitor Combination Shows Promise in Primary CNS Lymphoma Trial

Targeted TherapyOncology
  • A phase II trial of orelabrutinib combined with rituximab and high-dose methotrexate achieved a 71.4% overall response rate in newly diagnosed primary central nervous system lymphoma patients.
  • The combination demonstrated favorable safety with manageable toxicity, including 25% grade 3 adverse events and no treatment-related deaths in the 28-patient study.
  • At median follow-up of 21.6 months, median progression-free survival reached 35.3 months with 1-year survival rates of 64.3% for progression-free and 96.3% for overall survival.

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

NCT05600660RecruitingPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University
Posted 8/1/2022

Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

NCT05549284RecruitingPhase 2
Affiliated Hospital to Academy of Military Medical Sciences
Posted 6/1/2022

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

NCT05021770Unknown StatusPhase 1
Huiqiang Huang
Posted 12/1/2021

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

NCT05036577Active, Not RecruitingPhase 1
Huashan Hospital
Posted 10/10/2021

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

NCT05334238RecruitingPhase 3
Ruijin Hospital
Posted 12/1/2021

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

NCT05390749RecruitingPhase 2
Peking Union Medical College Hospital
Posted 4/11/2022

Zai Lab to Present Phase 1 Data on Novel DLL3-Targeted ADC for Small Cell Lung Cancer at ASCO 2025

OncologyTargeted Therapy
  • Zai Lab will showcase updated results from its Phase 1a/1b trial of ZL-1310, a potentially best-in-class DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer at the 2025 ASCO Annual Meeting.
  • The novel ADC utilizes TMALIN® technology platform to overcome limitations of first-generation ADCs by leveraging the tumor microenvironment, with the FDA granting Orphan Drug Designation in January 2025.
  • ZL-1310 combines a humanized anti-DLL3 monoclonal antibody with a novel camptothecin derivative payload, targeting an antigen overexpressed in aggressive neuroendocrine tumors associated with poor outcomes.

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

NCT03929666Active, Not RecruitingPhase 2
Jazz Pharmaceuticals
Posted 8/29/2019

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

NCT06179069RecruitingPhase 1
Zai Lab (Shanghai) Co., Ltd.
Posted 1/23/2024

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

NCT05091567Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/18/2021

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

NCT05152147Active, Not RecruitingPhase 3
Jazz Pharmaceuticals
Posted 12/2/2021

Phase 3 MoonRISe-1 Trial Evaluates TAR-210 Erdafitinib System for Bladder Cancer

Targeted TherapyOncologyPrecision Medicine
  • Johnson & Johnson launches Phase 3 MoonRISe-1 trial investigating TAR-210, a novel intravesical erdafitinib-releasing system, versus standard BCG therapy for non-muscle invasive bladder cancer.
  • TAR-210 represents an innovative targeted approach for FGFR-positive bladder cancer patients, potentially offering improved local drug delivery with reduced systemic side effects.
  • The study aims to assess efficacy and safety outcomes in patients with high-risk non-muscle invasive bladder cancer, addressing a significant unmet need in bladder cancer treatment.

Alberta Expands Public Access to Pluvicto Radioligand Therapy for Advanced Prostate Cancer

Targeted Therapy
  • Alberta joins Ontario and Nova Scotia in providing public reimbursement for Pluvicto, a targeted radioligand therapy for PSMA-positive metastatic castration-resistant prostate cancer.
  • The therapy is now publicly funded in three Canadian provinces, marking significant progress in expanding access to this first-in-class treatment approved by Health Canada in August 2022.
  • Pluvicto combines a targeting compound with a therapeutic radioisotope to selectively bind to and destroy prostate cancer cells expressing PSMA, offering hope for patients who have exhausted other treatment options.

Robust Pipeline for Nasopharyngeal Cancer Treatment Emerges with 25+ Pharmaceutical Companies Developing Novel Therapies

OncologyTargeted Therapy
• A comprehensive pipeline analysis reveals over 25 pharmaceutical companies actively developing approximately 30 drug candidates for nasopharyngeal cancer, signaling significant industry investment in this therapeutic area.
• BL-B01D1, a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3, has advanced to Phase III clinical trials, showing promise for patients with recurrent or metastatic nasopharyngeal carcinoma.
• Novel approaches in development include Takeda's TAK-500, a STING agonist immunostimulatory antibody drug conjugate, and Ascentage Pharma's APG-5918, highlighting diverse therapeutic strategies targeting this challenging cancer.

Targeted Therapies and Immunotherapy Advances in Non-Small Cell Lung Cancer: A Comprehensive Review

Targeted TherapyCAR-TOncologyPrecision Medicine
  • Targeted therapies for NSCLC have revolutionized treatment for patients with specific genetic alterations, with EGFR, ALK, and ROS1 inhibitors showing significant improvements in progression-free survival compared to traditional chemotherapy.
  • Immunotherapy, particularly immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4, has become a cornerstone in NSCLC treatment, with newer targets like LAG-3, TIM-3, and TIGIT showing promise in ongoing clinical trials.
  • Advanced cellular therapies including adoptive cell transfer, CAR-T cells, and cancer vaccines represent the next frontier in NSCLC treatment, particularly for patients with "cold tumors" who don't respond to standard immunotherapies.

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT02366143CompletedPhase 3
Hoffmann-La Roche
Posted 3/31/2015

Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies

NCT02706392TerminatedPhase 1
Fred Hutchinson Cancer Center
Posted 3/16/2016

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

NCT02187848TerminatedPhase 1
Sanofi
Posted 7/23/2014

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

NCT03652077CompletedPhase 1
Incyte Corporation
Posted 9/24/2018

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

NCT01121393CompletedPhase 3
Boehringer Ingelheim
Posted 4/19/2010

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

NCT03709706TerminatedPhase 1
GlaxoSmithKline
Posted 12/31/2018

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

NCT02125461CompletedPhase 3
AstraZeneca
Posted 5/7/2014

Biological Therapy in Treating Patients With Metastatic Cancer

NCT00004604CompletedPhase 1
Duke University
Posted 2/1/1997

Avelumab in First-line NSCLC (JAVELIN Lung 100)

NCT02576574CompletedPhase 3
EMD Serono Research & Development Institute, Inc.
Posted 10/29/2015

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826CompletedPhase 3
Bristol-Myers Squibb
Posted 8/5/2015

PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

NCT03365791CompletedPhase 2
Novartis Pharmaceuticals
Posted 1/24/2018

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03563716Active, Not RecruitingPhase 2
Genentech, Inc.
Posted 8/10/2018

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

NCT02075840CompletedPhase 3
Hoffmann-La Roche
Posted 8/19/2014

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

NCT00949650CompletedPhase 3
Boehringer Ingelheim
Posted 8/14/2009

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

NCT01642004CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2012

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

NCT00446225CompletedPhase 3
Spanish Lung Cancer Group
Posted 2/15/2007

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

NCT05834348Completed
Pfizer
Posted 6/23/2023

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

NCT04140500Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 11/11/2019

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

NCT03562871CompletedPhase 1
IO Biotech
Posted 8/22/2018

A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

NCT04931654Active, Not RecruitingPhase 1
AstraZeneca
Posted 9/28/2021

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

NCT03525782Unknown StatusPhase 1
The First Affiliated Hospital of Guangdong Pharmaceutical University
Posted 2/1/2018

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

NCT01774721CompletedPhase 3
Pfizer
Posted 5/9/2013

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

NCT03708328CompletedPhase 1
Hoffmann-La Roche
Posted 10/15/2018

CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor

NCT03182816Unknown StatusPhase 1
Shanghai Cell Therapy Research Institute
Posted 6/7/2017

Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer

NCT04348643Unknown StatusPhase 1
Chongqing Precision Biotech Co., Ltd
Posted 2/20/2020

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer

NCT01583686TerminatedPhase 1
National Cancer Institute (NCI)
Posted 5/4/2012

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

NCT00585195CompletedPhase 1
Pfizer
Posted 4/19/2006

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

NCT03849469CompletedPhase 1
Xencor, Inc.
Posted 5/29/2019

Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

NCT02608268TerminatedPhase 1
Novartis Pharmaceuticals
Posted 11/23/2015

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614CompletedPhase 3
Regeneron Pharmaceuticals
Posted 3/6/2018

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

NCT03625323CompletedPhase 2
Immutep S.A.S.
Posted 2/18/2019

Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

NCT02414269Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 5/1/2015

A Trial of ChAdOx1 and MVA Vaccines Against MAGE-A3 and NY-ESO-1

NCT04908111SuspendedPhase 1
Cancer Research UK
Posted 10/15/2021

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

NCT02737501CompletedPhase 3
Ariad Pharmaceuticals
Posted 5/26/2016

A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

NCT02349724Unknown StatusPhase 1
Southwest Hospital, China
Posted 12/1/2014

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

NCT02475213CompletedPhase 1
MacroGenics
Posted 7/1/2015

Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001)

NCT02964013CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 12/13/2016

MGC018 With or Without MGA012 in Advanced Solid Tumors

NCT03729596TerminatedPhase 1
MacroGenics
Posted 11/21/2018

Trial of RNActive®-Derived Cancer Vaccine and Local Radiation in in Stage IV Non Small Cell Lung Cancer (NSCLC)

NCT01915524TerminatedPhase 1
CureVac
Posted 4/1/2013

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors

NCT03689192CompletedPhase 1
Herlev Hospital
Posted 12/17/2018

Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients

NCT02879760CompletedPhase 1
Turnstone Biologics, Corp.
Posted 3/8/2017

Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)

NCT01295827CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 3/4/2011

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

NCT01203917CompletedPhase 4
AstraZeneca
Posted 9/1/2010

Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer

NCT02381314CompletedPhase 1
MacroGenics
Posted 3/26/2015

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

NCT03970746Active, Not RecruitingPhase 1
PDC*line Pharma SAS
Posted 9/10/2019

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

NCT04117087Active, Not RecruitingPhase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 5/28/2020

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

NCT01903993CompletedPhase 2
Hoffmann-La Roche
Posted 8/6/2013

Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00923312CompletedPhase 1
CureVac
Posted 5/1/2009

Efficacy Study of Vx001 Vaccine in NSCLC Patients

NCT01935154CompletedPhase 2
Vaxon Biotech
Posted 8/1/2012

Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor

NCT02587689Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2015

A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors

NCT05202561Unknown StatusPhase 1
First Affiliated Hospital Bengbu Medical College
Posted 3/10/2022

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

NCT01970865CompletedPhase 1
Pfizer
Posted 1/8/2014

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978CompletedPhase 2
Hoffmann-La Roche
Posted 4/12/2012

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

NCT04623775Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 2/17/2021

A Trial of AK104 Plus Anlotinib in NSCLC

NCT04646330Active, Not RecruitingPhase 1
Akeso
Posted 11/18/2020

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

NCT01336634CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/5/2011

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

NCT03219268CompletedPhase 1
MacroGenics
Posted 8/18/2017

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 4/11/2018

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

NCT05239143Active, Not RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 2/15/2022

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

NCT05060796RecruitingEarly Phase 1
Second Affiliated Hospital of Guangzhou Medical University
Posted 9/1/2019

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

NCT00932893CompletedPhase 3
Pfizer
Posted 9/1/2009

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.
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