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KEYNOTE-119 tested pembrolizumab on its own against chemotherapy as second- or third-line treatment for metastatic triple-negative breast cancer. It did not lengthen life, even in tumours with high PD-L1, which is why immunotherapy in this disease is given with chemotherapy or an antibody-drug conjugate and only in the first line.
KEYNOTE-119 (NCT02555657) randomised 622 patients with centrally confirmed metastatic triple-negative breast cancer, one or two prior systemic treatments and prior anthracycline or taxane, 1 to 1 to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or single-agent chemotherapy of the investigator's choice (capecitabine, eribulin, gemcitabine or vinorelbine). The primary endpoint was overall survival tested hierarchically in CPS 10 or more, CPS 1 or more and all patients. At a median follow-up of 31.4 months median overall survival in CPS 10 or more was 12.7 versus 11.6 months (hazard ratio 0.78, 95 percent confidence interval 0.57 to 1.06, p 0.057), in CPS 1 or more 10.7 versus 10.2 months (0.86, 0.69 to 1.06, p 0.073) and overall 9.9 versus 10.8 months (0.97, 0.82 to 1.15). Grade 3 to 4 treatment-related adverse events were far less common with pembrolizumab (for example neutropenia below 1 versus 10 percent). The trend with rising PD-L1 expression fed the CPS 10 threshold used in KEYNOTE-355, but the trial itself was negative, pembrolizumab has no monotherapy indication in breast cancer, and NICE discontinued its appraisal of pembrolizumab for previously treated metastatic triple-negative disease (GID-TA10295).
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
622 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, PD-L1 CPS 10 or moreprimary | Pembrolizumab | - | 12.7 months | 0.78 (0.57 to 1.06) | 0.057 | link |
| Chemotherapy | - | 11.6 months | ||||
| Overall survival, PD-L1 CPS 1 or moreprimary | Pembrolizumab | - | 10.7 months | 0.86 (0.69 to 1.06) | 0.073 | link |
| Chemotherapy | - | 10.2 months | ||||
| Overall survival, all patientsprimary | Pembrolizumab | 312 | 9.9 months | 0.97 (0.82 to 1.15) | - | link |
| Chemotherapy | 310 | 10.8 months |
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
Shares Vinorelbine, Capecitabine, Metastatic triple-negative breast cancer, Cytotoxic chemotherapy.
Shares Metastatic triple-negative breast cancer, Merck & Co. (MSD), Gemcitabine, Triple-negative breast cancer (TNBC).
Shares Eribulin, Capecitabine, Metastatic triple-negative breast cancer, Cytotoxic chemotherapy.
Shares KEYNOTE-355, Combined positive score (CPS), Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC).
Shares Eribulin, Capecitabine, Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC).
Shares Capecitabine, Metastatic triple-negative breast cancer, Triple-negative breast cancer (TNBC), Cytotoxic chemotherapy.