Jan 24, 2024
ProTarget Drugs and Acceptable Genomic Alterations
Patients may be eligible to treatment if they have a genomic alteration matching one of the listed drugs and a cancer outside the drug-specific EMA-approved label. All general and drug-specific in- and exclusion criteria according to the protocol must be met. Each patient-drug match must be confirmed by the Danish National Molecular Tumor Board before the patient can be enrolled in the trial.
| Drug | Acceptable Genomic Alterations | Excluded Genomic Alterations |
|---|---|---|
| Atezolizumab | MSI high POLE mutations: R150X, P286R, P286H, S297F, Y298fs, F367S, V411L, L424V, P436R, V437M, S459F, R573L, E597K, R665W, L698fs, R762W, R793C, K1008N, T1052M, R1111Q, L1235I, V1368M, R1519C, P1547S, R1826W, R1879C, Y1889C, S1892N, A1967V, A2213V, A2243T POLD1 mutations: W79L, P112fs, A930fs, N247I, R352C, Q461H, S478N, A864T, E1105D TMB ≥10 mut/mb | None |
| Niraparib | Germline or somatic BRCA1/BRCA2 inactivating mutations ATM/ATR mutations or deletions HRD positive | None |
| Pemigatinib | Mutations in PDGFRA, PDGFRB, or with PCM1-JAK2 fusion FGF/FGFR alterations (amplification, mutations and fusions) | |
| Selpercatinib | Activating RET gene alterations (fusions or mutations) | |
| Trastuzumab plus Pertuzumab | ERBB2 amplification, overexpression, or mutations: G309A, G309E, S310F, D769H, D769Y, L755S, V777L, V842I, E321G, R896C ERBB2 P780 insertions ERBB2 deletions in the region L755–T759 | None |
| Trastuzumab emtansine | ERBB2 amplification, or overexpression, or presence of any activating ERBB2 mutations | None |
| Vemurafenib plus Cobimetinib | BRAF V600E/D/K/R mutations | Any mutations in MAP2K1, MAP2K2, MEK1, MEK2, NRAS |
| Vismodegib | PTCH1 deletion or inactivating mutations | SMO mutations: D473G/H/Y, W535L GLI2 amplification |