Study [reference] Immunotherapy agent (target) | Chemotherapy regimen | Sub-group | Immunotherapy | Control (placebo) | EFS results (IT versus control) | ||
Number | pCR* (%) | Number | pCR* (%) | ||||
KEYNOTE-522[1,2] Pembrolizumab (PD-1) | Weekly paclitaxel with carboplatin (weekly or every 3 weeks) for 12 weeks followed by doxorubicin or epirubicin and cyclophosphamide for 4 cycles | All | 784 | 65¶ | 390 | 51¶ | At median follow-up of 39 months, 3-year EFS 84 versus 77% (HR 0.63, 95% CI 0.48-0.82) |
PD-L1+ | 656 | 69 | 317 | 55 | |||
PD-L1– | 127 | 45 | 69 | 30 | |||
Impassion031[3] Atezolizumab (PD-L1) | Weekly nabpaclitaxel for 12 weeks followed by doxorubicin and cyclophosphamide for 4 cycles | All | 165 | 58 | 168 | 41 | At approximately 20 months' median follow-up, EFS not reached (HR 0.76, 95% CI 0.4-1.44) |
PD-L1+ | 77 | 69 | 75 | 49 | |||
PD-L1– | 88 | 48 | 93 | 34 | |||
NeoTRIPaPDL1[4] Atezolizumab (PD-L1) | Nabpaclitaxel and carboplatin days 1 and 8 every 21 days for 8 cycles | All | 138 | 49 | 142 | 44 | Not reported |
PD-L1+ | 79 | 60 | 77 | 52 | |||
PD-L1– | 59 | 34 | 65 | 35 | |||
GeparNUEVO[5,6] Durvalumab (PD-L1) | Weekly nabpaclitaxel for 12 weeks followed epirubicin and cyclophosphamide for 4 cycles | All | 88 | 53 | 86 | 44 | At median follow-up of 42 months, 3-year iDFS 85 versus 77% (HR 0.54, 95% CI 0.27-1.09) |
PD-L1+ | 69 | 58 | 69 | 51 | |||
PD-L1– | 11 | 44 | 9 | 18 | |||
WindowΔ | 59 | 61 | 58 | 41 |
IT: immunotherapy; pCR: pathologic complete response; PD-1: programmed cell death protein 1; EFS: event-free survival; PD-L1: programmed cell death ligand 1; HR: hazard ratio; iDFS: invasive disease-free survival.
* pCR: ypT0/isN0.
¶ The pCR values listed for KEYNOTE-522 comes from the initial presentation of results for the first 602 patients. When results for all patients were available, final pCR rates were 63 and 56% for pembrolizumab and placebo, respectively.
Δ The first 117 patients treated on GeparNeuvo received a single dose of either durvalumab or placebo two weeks before starting neoadjuvant chemotherapy with the same agent; this was omitted after the study's independent data monitoring committee expressed concern about the delay in the start of chemotherapy; another 57 patients were subsequently treated without this "window" treatment.Do you want to add Medilib to your home screen?