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    DRUG:

    pamvatamig (MCLA-129)

    i
    Other names: MCLA-129, MCLA129, MCLA 129
    Company:
    Betta Pharma, Merus
    Drug class:
    EGFR inhibitor, c-MET inhibitor
    Related drugs:
    2d
    Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=164, Recruiting, Betta Pharmaceuticals Co., Ltd.
    New P1/2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • CLDN18 (Claudin 18)
    |
    HER-2 positive • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET amplification • MET exon 14 mutation • MET overexpression • MET mutation
    |
    Ensacove (ensartinib) • pamvatamig (MCLA-129)
    15d
    METex14: Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination (clinicaltrials.gov)
    P1/2, N=194, Active, not recruiting, Merus B.V. | Recruiting --> Active, not recruiting | N=576 --> 194
    Enrollment closed • Enrollment change
    |
    Tagrisso (osimertinib) • pamvatamig (MCLA-129)
    12ms
    Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification. (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Betta Pharmaceuticals Co., Ltd.
    New P2 trial
    |
    pamvatamig (MCLA-129)
    1year
    Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Betta Pharmaceuticals Co., Ltd. | Trial completion date: Jun 2025 --> Dec 2028 | Trial primary completion date: Jun 2024 --> Apr 2028
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive • MET positive
    |
    pamvatamig (MCLA-129)
    over1year
    METex14: Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination (clinicaltrials.gov)
    P1/2, N=576, Recruiting, Merus N.V. | N=380 --> 576 | Trial completion date: Apr 2025 --> Mar 2027 | Trial primary completion date: Apr 2024 --> Mar 2026
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Tagrisso (osimertinib) • pamvatamig (MCLA-129)
    over2years
    Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC) (ESMO Asia 2023)
    Pts received a median of 2 lines of prior systemic therapy, including anti-PD-(L)1 (78%) and platinum-based chemotherapy (89%); 28% received cetuximab in the RM setting. No cases of interstitial lung disease were reported in this cohort. Conclusions MCLA-129 monotherapy demonstrated antitumor activity in pts with pretreated RM HNSCC with a manageable safety profile.
    Clinical
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET expression
    |
    Erbitux (cetuximab) • pamvatamig (MCLA-129)
    over2years
    Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, combined with osimertinib, as first-line therapy or after progression on osimertinib in non-small cell lung cancer (NSCLC) (ESMO Asia 2023)
    Conclusions MCLA-129 plus osimertinib showed promising clinical efficacy in EGFRmut NSCLC, in 1L and 2L+. IRRs and ILD/pneumonitis were observed.
    Clinical
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR expression • MET expression
    |
    Tagrisso (osimertinib) • pamvatamig (MCLA-129)
    over2years
    Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation (clinicaltrials.gov)
    P1, N=172, Not yet recruiting, Betta Pharmaceuticals Co., Ltd.
    New P1 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Semena (befotertinib) • pamvatamig (MCLA-129)
    almost3years
    Preclinical evaluation of MCLA-129, a bispecific antibody targeting EGFR and c-MET on solid tumor cells, in comparison with amivantamab (AACR 2023)
    A phase 1/2 clinical trial of MCLA-129 in solid tumors is ongoing. These data support the further clinical development of MCLA-129 in patients with NSCLC and other solid tumors.
    Preclinical • Tumor cell
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET exon 14 mutation • MET mutation
    |
    Rybrevant (amivantamab-vmjw) • pamvatamig (MCLA-129) • onartuzumab (RG3638)
    3years
    A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=380, Recruiting, Merus N.V. | N=150 --> 380
    Enrollment change • Metastases
    |
    IL6 (Interleukin 6) • IL2 (Interleukin 2)
    |
    Tagrisso (osimertinib) • pamvatamig (MCLA-129)
    over3years
    MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors: an ongoing phase 1/2 study (AACR-NCI-EORTC 2022)
    At the data cut-off date of 8 May 2022, 20 pts were enrolled, across the 100, 300, 600, 1000 and 1500 mg cohorts. Median age was 65.5 years (range 43-79). Pts enrolled included: 14 pts with EGFR mutant (mt) NSCLC (4 pts L858R, 8 pts Del19, 1 pt exon 20 insertion , 1 pt with other mutation), 2 pts with c-MET exon 14 mt NSCLC, 1 pt with c-MET amplified gastric adenocarcinoma , 1 pt with squamous esophageal cancer , and 2 pts with HNSCC.
    Clinical • P1/2 data
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • MET amplification • EGFR exon 20 insertion • MET exon 14 mutation • MET mutation
    |
    pamvatamig (MCLA-129)
    almost4years
    Mechanism of action of MCLA-129, a bispecific antibody that targets EGFR and c-MET and impairs growth of EGFR exon 20 insertion mutant non-small cell lung cancer (AACR 2022)
    Mutagenesis analysis identified critical binding residues of domain III of EGFR for MCLA-129 binding that are distinct from cetuximab binding. MCLA-129 is a Biclonics® common light chain bispecific antibody with multiple mechanisms of action including potent inhibition of c-MET and EGFR ligand binding, ligand-induced receptor dimerization and phosphorylation, ADCC and ADCP. MCLA-129 demonstrates significant growth inhibition of a patient-derived EGFR exon20ins tumor in a preclinical xenograft model. A phase 1/2 clinical trial of MCLA-129 in solid tumors is ongoing.
    EGFR exon 20
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Erbitux (cetuximab) • pamvatamig (MCLA-129)