Localized prostate cancer
Adjuvant docetaxel after primary radiation therapy
Metastatic castration resistant prostate cancer (mCRPC)
Radium-223 dosis escalation
Radium-223 plus enzalutamide
PARP inhibition
Localized muscle-invasive bladder cancer (MIBC)
Checkpoint inhibitors in the neoadjuvant setting prior to radical cystectomy
ABACUS [23], Abstract #4506 | PURE-01 [24], Abstract #4507 | ||
---|---|---|---|
Phase | II | II | |
Study population (n) | 68 | 43 | |
Checkpoint inhibitor | Atezolizumab | Pembrolizumab | |
Number of cycles | 2 | 3 | |
Cisplatin-fit? | Cisplatin-unfit | Cisplatin-fit | |
Residual tumor after TURB | Yes | Yes | |
TNM for inclusion | cT2-T4aN0-N1 | ≤cT3bN0 | |
pCR | Overall | 29% | 39.5% |
PD-L1+ | 40% (≥5% IC) | 50% (CPS score ≥ 20%) | |
PD-L1− | 16% | – | |
PD-L1+ and DDR/RB1-GA: 90% | |||
DDR and/or RB1-GA: 60% | |||
Discontinuation/progression during CPI (n) | 1 (1.5%) | 1 (2.3%) | |
Most common AEs | 21% fatigue | 11% hyperthyroidism | |
Biomarkers | PD-L1 | CPS Score, TMB | |
CD8 | 22-gene T‑cell inflamed panel qPCR | ||
Genomic profiling |
Metastatic urothelial carcinoma (mUC)
Overall survival (OS) updates of pembrolizumab and atezolizumab in the 1st line setting of cisplatin-unfit patients
KEYNOTE-052 [29], Abstract #4524 | IMvigor210 (Cohort 1) [28], Abstract #4523 | EORTC 30986 | |
---|---|---|---|
Study population (n) | 370 | 119 | 238 |
ORR (%) | 28.9 | 24 | 36 |
CR Rate (%) | 8.1 | 8 | 6.1 |
Median OS (months) | 11.5 | 16.3 | 9.3 |
1-Year OS rate (%) | 47.5 | 58 | 37 |
2-Year OS rate (%) | – | 41 | 18 |
Targeted therapies in chemotherapy- and IO-refractory mUC
ROGARATINIB [37], Abstract #4513 N = 51 | ERDAFITINIB [38], Abstract #4503 N = 99 | ENFORTUMAB [42], Abstract #4504 N = 112 | |
---|---|---|---|
Phase | I | II | I |
Dosage | 800 mg twice daily | 8 mg daily (up to 9 mg) | 1.25 mg/kg (day 1, 8, 15) |
Target | FGFR1-4 | FGFR1-4 | Nectin-4 |
Inclusion criteria | ≧1 line Cx | ≧1 line Cx or | ≧1 line Cx or |
Cisplatin-unfit | Cisplatin-unfit | ||
Prior IO allowed | Prior IO allowed | Prior IO allowed | |
Visceral metastasis | – | 79% | 77% |
Crea Clearance < 60 | 53% | 50% | |
≧2 lines systemic Cx | 43% | 63% | |
Prior IO | 23% | 79% | |
FGFR mutations | FGFR3+ 87% | FGFR3 mutation 75% | – |
FGFR1+ 5% | FGFR2/3 fusion 25% | ||
Dual FGFR +8% | |||
ORR | |||
Overall | 24% | 40.4% | 41% |
Prior IO | 30% | 59% | 40% |
Visceral metastasis | – | 38.5% | 39% |
Median PFS (months) | – | 5.5 | 5.4 |
Median OS (months) | – | 13.8 | 13.6 |
AEs | Diarrhea (60.8%) | Hyperphosphatemia (73%) | Fatigue (54%) |
Hyperphosphatemia (45.1%) | Skin disorders (49%) | Grade ≧ 3 AEs: anemia 8%, hyponatremia 7%, UTI 7%, and hyperglycemia 6% | |
Nail disorders (52%) |