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    BIOMARKER:

    ALK wild-type

    i
    Other names: NBLST3, CD246, Anaplastic Lymphoma Kinase, Anaplastic Lymphoma Kinase (Ki-1), CD246 Antigen, Mutant Anaplastic Lymphoma Kinase, ALK, ALK Receptor Tyrosine Kinase, Anaplastic Lymphoma Receptor Tyrosine Kinase, ALK Tyrosine Kinase Receptor
    Entrez ID:
    238
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    21d
    AK105-301: A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=164, Terminated, Akeso | Trial completion date: Jun 2024 --> Dec 2023 | Active, not recruiting --> Terminated; corporate strategy adjustment
    Trial completion date • Trial termination • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    carboplatin • Focus V (anlotinib) • pemetrexed • Anniko (penpulimab)
    2ms
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2027 --> Apr 2026
    Enrollment open • Trial primary completion date • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    2ms
    The association of genomic alterations with PD-L1 expression in Chinese patients with EGFR/ALK wild-type lung adenocarcinoma and potential predictive value of Hippo pathway mutations to immunotherapy. (PubMed, Cancer Med)
    This study offers insights into genomic features of Chinese EGFR/ALK wild-type lung adenocarcinoma patients based on PD-L1 expression. Notably, Hippo pathway alterations were linked to improved immunotherapy outcomes. These findings suggest connections between the Hippo pathway and PD-L1 expression, warranting further clinical and functional investigations. The research advances our understanding of PD-L1 expression's genomic context and immunotherapy response in EGFR/ALK wild-type lung adenocarcinoma.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD68 (CD68 Molecule)
    |
    PD-L1 expression • TMB-H • EGFR expression • EGFR wild-type • ALK wild-type
    2ms
    PACIFIC-8: A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (clinicaltrials.gov)
    P3, N=860, Recruiting, AstraZeneca | Trial completion date: Sep 2029 --> Aug 2030 | Trial primary completion date: Jun 2027 --> Jun 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    2ms
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    2ms
    Cumulative incidence and risk factors of brain metastases in metastatic non-small cell lung cancer without baseline brain metastasis: Pooled analysis of individualized patient data from IMpower130, IMpower131, and IMpower150. (PubMed, Cancer)
    In patients with metastatic EGFR/ALK wild-type NSCLC without baseline BMs, adding atezolizumab in the first-line treatment might not reduce the CI-BM. However, the administration of bevacizumab may reduce the risk of BMs.
    Retrospective data • Journal • PD(L)-1 Biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK mutation • ALK wild-type
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab)
    3ms
    LOTOS: A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    3ms
    BMC128-001: A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Biomica Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR wild-type • ALK wild-type
    |
    Opdivo (nivolumab) • BMC128
    4ms
    Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trial. (PubMed, Br J Cancer)
    PIPSeN was terminated early after enrollment of only 50% of the pre-planned population, thus being statistically underpowered. Olaparib maintenance did neither improve median PFS nor OS in this patient population.
    P2 data • Journal • PARP Biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    ALK wild-type
    |
    Lynparza (olaparib)
    5ms
    The association of chest computed tomography-defined visual emphysema and prognosis in patients with nonsmall cell lung cancer. (PubMed, ERJ Open Res)
    CT-defined emphysema, especially CLE with LAA%>17%, is an independent predictor of NSCLC prognosis. Moreover, prospective studies are needed to further explore this association.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    6ms
    Induction Chemo-Nivo in Unresectable Stage III NSCLC (clinicaltrials.gov)
    P2, N=37, Recruiting, Ralph G Zinner | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Surgery
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK wild-type • ROS1 wild-type
    |
    Opdivo (nivolumab) • paclitaxel • docetaxel
    6ms
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Sep 2027 | Trial primary completion date: Apr 2026 --> Mar 2027
    Trial completion date • Trial primary completion date • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    6ms
    Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in first-line metastatic (m) NSCLC: 5-year overall survival (OS) update from the POSEIDON study (ESMO-IO 2023)
    Conclusions Updated analyses from POSEIDON after median FU of >5 y showed durable long-term OS benefit with the approved regimen of T+D+CT (vs CT alone). These results support its use as a 1L treatment option for pts with mNSCLC, including harder-to-treat subgroups such as those with PD-L1 TC <1%.
    Late-breaking abstract • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    PD-L1 expression • KRAS mutation • EGFR wild-type • STK11 mutation • ALK wild-type • KEAP1 mutation
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    7ms
    Comprehensive genomic and immune profiling of ALK fusion-positive and negative lung adenocarcinomas (SITC 2023)
    Our results show that ALK rearrangements are associated with elevated levels of PD-L1 tumore expression. These findings support consideration for including patients with ALK+ LAs in appropriate clinical trials.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • ALK positive • ALK rearrangement • ALK fusion • ALK wild-type
    |
    PD-L1 IHC 22C3 pharmDx
    7ms
    Avelumab vs platinum-based doublet chemotherapy as first-line treatment for patients with high-expression PD-L1+ metastatic non-small cell lung cancer: primary analysis from the phase 3 JAVELIN Lung 100 trial. (PubMed, J Thorac Oncol)
    P3; Longer median OS and PFS were observed with avelumab vs platinum-based doublet chemotherapy in advanced NSCLC, but differences in OS and PFS were not statistically significant, and the trial did not meet its primary objective.
    Journal • P3 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    PD-L1 IHC 73-10 pharmDx
    |
    Bavencio (avelumab)
    8ms
    Induction Chemo-Nivo in Unresectable Stage III NSCLC (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, Ralph G Zinner
    New P2 trial • Combination therapy • Surgery
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK wild-type • ROS1 wild-type
    |
    Opdivo (nivolumab) • paclitaxel • docetaxel
    8ms
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    8ms
    ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov)
    P1, N=279, Active, not recruiting, Jazz Pharmaceuticals | Trial completion date: Aug 2023 --> Jul 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion
    |
    paclitaxel • capecitabine • Tukysa (tucatinib) • vinorelbine tartrate • zanidatamab (ZW25)
    9ms
    Genetic Predictors of Benefit to Pembrolizumab (clinicaltrials.gov)
    P2, N=19, Terminated, Columbia University | Active, not recruiting --> Terminated; Frontline pembrolizumab approved in NSCLC as monotherapy and in combination with chemotherapy representing a new standard of care.
    Trial termination • Combination therapy • Tumor mutational burden • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS mutation • EGFR mutation • EGFR wild-type • KRAS wild-type • RAS mutation • ALK wild-type
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed
    9ms
    Durvalumab ± Tremelimumab + Chemotherapy in 1L Metastatic NSCLC: Characterisation of patients with PFS ≥12 months in POSEIDON (IASLC-WCLC 2023)
    In POSEIDON, more than twice as many patients derived long-term clinical benefit (PFS 12 months) when treated with T+D+CT versus CT alone (16.6% vs 6.8%).
    Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    9ms
    The Safety and Efficacy of Induction Chemoimmunotherapy Followed by Radiotherapy and Consolidation Immunotherapy in Locally Advanced NSCLC (IASLC-WCLC 2023)
    Patients received 3 cycles of carboplatin, paclitaxel (squamous NSCLC) or pemetrexed (non-squamous NSCLC), and tislelizumab, followed by standard thoracic radiotherapy. The findings of this study suggest promising antitumor activity and manageable safety of induction chemoimmunotherapy followed by radiotherapy and consolidation immunotherapy in patients with locally advanced NSCLC.
    Clinical • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    carboplatin • paclitaxel • Tevimbra (tislelizumab) • pemetrexed
    9ms
    LIPI-based Score Predicting OS Benefit for the Addition of Chemotherapy to Pembrolizumab in aNSCLC with PD-L1 TPS≥50% (IASLC-WCLC 2023)
    With the limitations of the retrospective analysis, the proposed LIPI-based score seems to predict OS with P and PCT. Prospective validation is required.
    PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    LDH elevation • ALK wild-type • ROS1 wild-type
    |
    Keytruda (pembrolizumab)
    9ms
    Real World Outcomes after Chemotherapy and Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer in Europe (IASLC-WCLC 2023)
    In this European cohort of patients with mNSCLC having disease progression on anti-PD-1/anti-PD-L1 and PDC, treatment regimens were heterogenous and predominantly included non-platinum chemotherapies. Poor clinical outcomes demonstrate an unmet clinical need that warrant more efficacious therapies for anti-PD-1/anti-PD-L1 and PDC-refractory patients.
    Clinical • Real-world evidence • Real-world • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR wild-type • ALK wild-type • ROS1 fusion • ALK-ROS1 fusion
    9ms
    Three-Year Outcomes with First-Line Pembrolizumab, in Patients with Non-Small-Cell Lung Cancer and A PD-L1 Tumor Proportion Score >90% (IASLC-WCLC 2023)
    Pembrolizumab monotherapy continues to demonstrate a meaningful long-term survival benefit in patients with advanced NSCLC and a PD-L1 TPS ≥90%. NSCLCs with very high PD-L1 TPS may have a more favorable genomic and immunophenotypic profile. These findings have important implications for treatment selection and clinical trial interpretation and design.
    Clinical • Tumor mutational burden • Tumor proportion score • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • STK11 (Serine/threonine kinase 11) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • KDM5C (Lysine Demethylase 5C) • FOXP3 (Forkhead Box P3)
    |
    PD-L1 expression • PD-L1 overexpression • HER-2 mutation • EGFR wild-type • STK11 mutation • ALK wild-type • SMARCA4 mutation
    |
    Keytruda (pembrolizumab)
    10ms
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    10ms
    LOTOS: A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy (clinicaltrials.gov)
    P2, N=38, Recruiting, AstraZeneca
    New P2 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    10ms
    Treatment patterns and outcomes of patients with metastatic non-small cell lung cancer in five European countries: a real-world evidence survey. (PubMed, BMC Cancer)
    Real-world treatment patterns suggest that chemotherapy use remains high despite guidelines recommending immunotherapy-based 1L treatment for mNSCLC. QoL reported by patients was generally lower than population reference values. Not implying causality, 1L immunotherapy use was higher during COVID-19 than pre-COVID-19, and the UK saw the biggest impact to patient management due to COVID-19.
    Journal • HEOR • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR wild-type • ALK mutation • ALK wild-type • EGFR wild-type + ALK wild-type • EGFR mutation + ALK mutation
    10ms
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, AstraZeneca
    New P2 trial • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    10ms
    This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment. (clinicaltrials.gov)
    P1, N=172, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    11ms
    PEOPLE (NTC03447678), a phase II trial to test pembrolizumab as first-line treatment in patients with advanced NSCLC with PD-L1 <50%: a multiomics analysis. (PubMed, J Immunother Cancer)
    P=N/A; This multiomics approach was able to identify immune cell subsets and expression levels of genes associated to PFS in patients with PD-L1 <50% NSCLC treated with first-line pembrolizumab. These preliminary data will be confirmed in the larger multicentric international I3LUNG trial (NCT05537922).
    Journal • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • KLRB1 (Killer Cell Lectin Like Receptor B1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    nCounter® PanCancer IO 360™ Panel
    |
    Keytruda (pembrolizumab)
    11ms
    Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC. (clinicaltrials.gov)
    P2, N=101, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Apr 2023 | Trial primary completion date: Aug 2023 --> Apr 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR exon 19 deletion • ALK positive • ALK rearrangement • EGFR wild-type • ALK wild-type • ALK translocation
    |
    Opdivo (nivolumab) • azacitidine • Jingzhuda (entinostat)
    11ms
    BMC128-001: A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov)
    P1, N=12, Recruiting, Biomica Ltd. | Trial completion date: May 2023 --> Nov 2025 | Trial primary completion date: Feb 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR wild-type • ALK wild-type
    |
    Opdivo (nivolumab) • BMC128
    12ms
    Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC (clinicaltrials.gov)
    P2, N=42, Recruiting, Georgetown University | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK wild-type • ROS1 wild-type
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • tiragolumab (RG6058)
    12ms
    Correlation of homologous recombination deficiency (HRD) score with response to the first-line treatment of immune checkpoint inhibitors plus chemotherapy in non-small cell lung cancer. (ASCO 2023)
    In addition to PD-L1 expression level, HRD score would be a potential promising biomarker for predicting the efficiency of ICIs plus platinum-based chemotherapy in NSCLC patients.
    Checkpoint inhibition • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • HRD (Homologous Recombination Deficiency)
    |
    PD-L1 expression • HRD • EGFR wild-type • ALK wild-type
    |
    PD-L1 IHC 22C3 pharmDx
    12ms
    SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study. (ASCO 2023)
    SI-B001 plus docetaxel demonstrated antitumor activity in locally advanced or metastatic NSCLC EGFR/ALK wild-type pts who failed on prior first-line anti-PD-1/L1 antibody plus PBC, especially without AGA. The toxicity of SI-B001 + docetaxel was manageable. These findings support the continued investigation of SI-B001 and docetaxel as a treatment option in NSCLC.
    Clinical • P2 data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    docetaxel • izalontamab (SI-B001)
    12ms
    Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8). (ASCO 2023)
    Previously presented at the European Society for Medical Oncology (ESMO) Congress 2022, FPN (Final Publication Number): 971TiP, Mustafa Özgüroğlu et al. – Reused with permission.Clinical trial information: NCT05211895.
    P3 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    PD-L1 expression • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    1year
    Cost-effectiveness evaluation based on two models of first-line atezolizumab monotherapy and chemotherapy for advanced non-small cell lung cancer with high-PDL1 expression. (PubMed, Front Oncol)
    In some areas of China with higher levels of economic development, atezolizumab was likely to be cost-effective. To improve the cost-effectiveness of atezolizumab, drug prices would need to be reduced.
    Journal • HEOR • PD(L)-1 Biomarker • IO biomarker • Cost-effectiveness • Cost effectiveness • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression • EGFR expression • EGFR wild-type • EGFR overexpression • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Tecentriq (atezolizumab)
    1year
    KRAS G12C mutated advanced non-small cell lung cancer (NSCLC): Characteristics, treatment patterns and overall survival from a Danish nationwide observational register study. (PubMed, Lung Cancer)
    In patients diagnosed with advanced NSCLC after the implementation of anti-PD-1/L1 therapies, the survival in KRAS G12C mutated patients is comparable to patients with any KRAS mutation, Triple WT, and all NSCLC patients.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • KRAS mutation • EGFR mutation • PD-L1 overexpression • KRAS G12C • EGFR wild-type • KRAS wild-type • ALK wild-type • KRAS G12
    1year
    Study protocol of KeyPemls-004: A phase 2 study of pembrolizumab in combination with plinabulin and docetaxel in previously treated patients with metastatic non-small cell lung cancer and progressive disease (PD) after immunotherapy (PD-1/PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy. (PubMed, Thorac Cancer)
    This trial will provide evidence of the benefit and safety of pembrolizumab in combination with plinabulin and docetaxel in metastatic NSCLC patients who have been exposed and developed resistance to first-line PD-1/PD-L1 inhibitor either as monotherapy or in combination with chemotherapy.
    Clinical protocol • P2 data • Journal • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    Keytruda (pembrolizumab) • docetaxel • plinabulin (BPI 2358)
    1year
    Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) in 1L metastatic NSCLC: Outcomes by blood tumor mutational burden (bTMB) in POSEIDON (AACR 2023)
    In pts with mNSCLC, treatment with a limited course of T plus D (until progression) and four cycles of CT consistently improved clinical outcomes vs CT alone in both bTMB high and low subgroups, supporting the use of this regimen as a 1L treatment option for pts with mNSCLC. The clinical benefit vs CT appeared to be greater in pts with higher bTMB over a range of cutoffs, consistent with expectations based on mechanistic biology and previous clinical data.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • EGFR wild-type • TMB-L • ALK wild-type
    |
    VENTANA PD-L1 (SP263) Assay • GuardantOMNI
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)