Abstract
Background: For early or locally advanced TNBC, preferred neoadjuvant strategies include a four-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Accumulating evidence suggests that blockade of the PD-1/PD-L1 pathway may enhance the efficacy of conventional neoadjuvant chemotherapy. Camrelizumab is an anti-PD-1 antibody that has demonstrated antitumor activity in advanced or metastatic TNBC. Herein, we conducted a double-blind, randomized phase 3 trial (NCT04613674) to evaluate the efficacy and safety of neoadjuvant camrelizumab plus chemo in early or locally advanced TNBC.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Background: For early or locally advanced TNBC, preferred neoadjuvant strategies include a four-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Accumulating evidence suggests that blockade of the PD-1/PD-L1 pathway may enhance the efficacy of conventional neoadjuvant chemotherapy. Camrelizumab is an anti-PD-1 antibody that has demonstrated antitumor activity in advanced or metastatic TNBC. Herein, we conducted a double-blind, randomized phase 3 trial (NCT04613674) to evaluate the efficacy and safety of neoadjuvant camrelizumab plus chemo in early or locally advanced TNBC.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial
Zhi-Ming Shao
Abstract
Background: For early or locally advanced TNBC, preferred neoadjuvant strategies include a four-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Accumulating evidence suggests that blockade of the PD-1/PD-L1 pathway may enhance the efficacy of conventional neoadjuvant chemotherapy. Camrelizumab is an anti-PD-1 antibody that has demonstrated antitumor activity in advanced or metastatic TNBC. Herein, we conducted a double-blind, randomized phase 3 trial (NCT04613674) to evaluate the efficacy and safety of neoadjuvant camrelizumab plus chemo in early or locally advanced TNBC.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Background: For early or locally advanced TNBC, preferred neoadjuvant strategies include a four-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Accumulating evidence suggests that blockade of the PD-1/PD-L1 pathway may enhance the efficacy of conventional neoadjuvant chemotherapy. Camrelizumab is an anti-PD-1 antibody that has demonstrated antitumor activity in advanced or metastatic TNBC. Herein, we conducted a double-blind, randomized phase 3 trial (NCT04613674) to evaluate the efficacy and safety of neoadjuvant camrelizumab plus chemo in early or locally advanced TNBC.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
Methods: Patients with previously untreated, invasive stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) TNBC were randomized (1:1) to receive neoadjuvant camrelizumab (200 mg, Q2W) or placebo plus chemo (nab-paclitaxel [100 mg/m2, D1, D8, D15, Q4W] + carboplatin [AUC 1.5, D1, D8, D15, Q4W] for 16 weeks, followed by dose-dense epirubicin [90 mg/m2, Q2W] + cyclophosphamide [500 mg/m2, Q2W] for 8 weeks). Randomization was stratified by tumor clinical stage (stage II vs III) and PD-L1 expression (combined positive score [CPS] <10 vs ≥10). After surgery, patients allocated to the camrelizumab group received camrelizumab (200 mg, Q2W) for up to a year (from first dose). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). Secondary endpoints included event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and pre-surgery objective response rate (ORR; per RECIST v1.1).
Results: As of data cutoff (Sep.30, 2023), 441 patients were randomized and treated (camrelizumab, n=222; placebo, n=219). Median follow-up was 14.4 mo. Overall, median age was 48.2 years; 35.8% of patients had stage III disease at baseline, and 70.5% presented with nodal involvement (N3 disease, 9.1%). pCR rate was 56.8% (95% CI 50.0-63.4) with camrelizumab + chemo and 44.7% (95% CI 38.0-51.6) with placebo + chemo (rate difference, 12.2% [95% CI 3.3 to 21.2]; 1-sided p=0.0038). The benefit in pCR with camrelizumab + chemo was observed regardless of PD-L1 expression, nodal status or disease stage at baseline. Specifically, among patients with poor prognostic factors, the pCR rate with camrelizumab + chemo vs placebo + chemo was 57.8% (89/154) vs 42.7% (67/157) for node-positive disease (rate difference, 15.1% [95% CI 4.1 to 26.1]), and 49.4% (39/79) vs 38.0% (30/79) for stage III disease (rate difference, 11.4% [95% CI -4.0 to 26.8]). Pre-surgery ORR reached 87.4% (95% CI 82.3 to 91.5) with camrelizumab + chemo and 82.6% (95% CI 77.0 to 87.4) with placebo + chemo. EFS (HR, 0.80 [95% CI 0.46-1.42]), DFS (HR 0.58 [95% CI 0.27 to 1.24]) and DDFS (HR 0.62 [95% CI 0.29-1.33]) were immature, with a trend favoring the camrelizumab + chemo group. Across stages, TRAEs of grade ≥3 occurred in 90.1% of patients in the camrelizumab + chemo group vs 82.6% in the placebo + chemo group; all events with incidence ≥10% were hematological toxicities.
Conclusions: Addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy significantly improved pCR rate in early or locally advanced TNBC, with a manageable safety profile. Early survival data also favored the camrelizumab + chemo group.
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