TABLE 1.
Progress of clinical trials of DOX liposomes in combination with PD-L1 inhibitors for the treatment of triple positive breast cancer.
| PD-L1 inhibitor | Trial | Stage | Patient population N) | Intervention | Outcome measures |
|---|---|---|---|---|---|
| Atezolizumab | ALICE NCT03164993 Røssevold et al. (2022) | the randomized, double-blind phase 2b (n = 79) | Stage II or III TNBC | Pegylated liposomal Doxorubicin (PLD)/Cyclophosphamide + Atezolizumab (Atezo-chemo; n = 40) VS. placebo (placebo-chemo; n = 28) | After 15 months was 14.7% (5/34; 95% CI 6.4%–30.1%) in the Atezo-chemo arm versus 0% in the placebo-chemo arm |
| Atezolizumab | IMpassion030 NCT03498716 Saji et al. (2021) | A global, prospective, randomized, open-label, phase III (n = 2300) | Stage II or III TNBC | paclitaxel 80 mg Saji et al. (2021) ubicin 60 mg/m2+cyclophosphamide 600 mg/m2 for 4 doses (2 weeks)+Atezolizumab or placebo | The invasive disease-free survival (iDFS) and secondary endpoints include, iDFS in the PD-L1 selected tumour status (IC1/2/3) and node-positive subpopulations, overall survival, safety, patient functioning and health related quality of life (HRQoL). Progress of the trial is still being assessed |
| Atezolizumab | IMpassion031 NCT03197935 Mittendorf et al. (2020) | Randomized Phase III 1:1 (n = 333) | Stage II or III TNBC | Nabpaclitaxel + carboplatin + pembrolizumab-AC + pembrolizumab-surgery Atezolizumab plus standard anthracycline/taxane adjuvant chemotherapy versus chemotherapy alone in early stage TNBC | Median follow-up was 20.6 months (IQR 8.7-24.9) in the Atezolizumab plus chemotherapy group and 19.8 months (8.1-24.5) in the placebo plus chemotherapy group |
| Pembrolizumab | NCT02648477 Yuan et al. (2022) | Phase I/II (n = 10) | The patients with previously untreated stage II or stage III TNBC | Patients received Pembrolizumab 200 mg and 50–60 mg/m2 Dox every 3 weeks, followed by Pembrolizumab maintenance until progression or unacceptable toxicity | The combination of Pembrolizumab + Dox was well tolerated and had modest activity in anthracycline-naïve patients with mTNBC |
| Pembrolizumab | KEYNOTE-173 NCT02622074 Schmid et al. (2020) | Phase I/II (n = 60) | High-risk, early-stage, non-metastatic TNBC | Patients received Pembrolizumab 200 mg (cycle 1) and paclitaxel Schmid et al. (2020) orubicin and cyclophosphamide (12 weeks) + surgery | pembrolizumab + chemotherapy for high-risk, early-stage TNBC showed manageable toxicity and promising antitumor activity, and the pCR rate showed a positive correlation with tumor PD-L1 expression and sTIL levels |
| Pembrolizumab | KEYNOTE-522 NCT03036488 Schmid et al. (2022) | Phase I (n = 1,174) | TNBC patients wi`th T1c N1-2/T2 N0-2 | the pembrolizumab-chemotherapy (TA) (n = 784) VS. Ngroupthe placebo-chemotherapy group (n = 390) | the percentage with a pathological complete response was significantly higher among those who received Pembrolizumab plus neoadjuvant chemotherapy than that of the control group |
| Durvalumab | MEDI4736 Foldi et al. (2022) | Phase I/II (n = 59) | Stage I to III TNBC | Durvalumab concurrent with weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide (ddAC) neoadjuvant therapy | Complete pathological remission (CPR)rate can be increased by 44% (95% CI: 30%–57%), Which is higher in cancers with high sTIL. |
| Durvalumab | GeparNuevo NCT02685059 Loibl et al. (2019) | Multicenter, prospective, randomized, double-blind,Phase II trial (n = 174) | TNBC patients with cT1b-cT4a-d | durvalumab 1.5 g Loibl et al. (2019) W plus nab-paclitaxel (125mg/m2, QW)for 12 weeks, followed by durvalumab/placebo plus epirubicin/cyclophosphamide followed by surgery | iDFS was 85.6% in the divalizumab group and 77.2% in the placebo group (HR 0.48, 95% CI 0.24-0.97, p = 0.036); DDFS was 91.7% vs. 78.4% (HR 0.31, 95% CI 0.13-0.74, p = 0.005) |