August 2021: Pembrolizumab (Keytruda, Merck) was approved by the FDA for high-risk, early-stage triple-negative breast cancer (TNBC) as a neoadjuvant treatment in combination with chemotherapy, and later as a single agent as adjuvant treatment following surgery.
Pembrolizumab in conjunction with chemotherapy was also given regular approval by the FDA for patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (Combined Positive Score [CPS] 10) as assessed by an FDA-approved test. In November 2020, the FDA gave pembrolizumab expedited approval for this indication.
Ukuvunyelwa kwe-neoadjuvant kanye ne-adjuvant, kanye necala lokuqinisekisa lokuthola imvume esheshayo, bekuncike ecaleni elilandelayo.
Ku-KEYNOTE-522 (NCT03036488), isilingo esilawulwa ngokungahleliwe, esinamacala amaningi, esingaboni kahle, esilawulwa nge-placebo esihilela iziguli ze-1174 ezine-TNBC esanda kutholakala isengozini enkulu engakalashwa. nge-pembrolizumab njenge-ejenti eyodwa, ukusebenza kahle kwe-pembrolizumab kuhlanganiswe ne-neoadjuvant chemotherapy elandelwa ukuhlinzwa nokuqhubeka Iziguli zafakwa kungakhathaliseki ukuvezwa kwe-PD-L1 ezimila zabo.
I-Pembrolizumab ihlangene ne-chemotherapy noma i-placebo ihlangene ne-chemotherapy yanikezwa iziguli ezinesilinganiso esingu-2: 1. Iphrothokholi ye-chemotherapy ichazwe ngokuningiliziwe kulebuli yezidakamizwa, exhunywe ngezansi.
Izinga lokuphendula okuphelele kwe-pathological (pCR) nokusinda ngaphandle kwemicimbi kwakuyimethrikhi yemiphumela yokusebenza okuyisisekelo (EFS). Iziguli ezithole i-pembrolizumab ngokuhlanganyela ne-chemotherapy zinezinga le-pCR lamaphesenti angu-63 (amaphesenti angu-95 CI: 59.5, 66.4), uma kuqhathaniswa namaphesenti angu-56 (amaphesenti angu-95 CI: 50.6, 60.6) ezigulini ezithole i-chemotherapy kuphela. Inani leziguli ezazineziqephu ze-EFS kwakungu-123 (16%) no-93 (24%), ngokulandelana (HR 0.63; 95% CI: 0.48, 0.82; p = 0.00031).
Ukukhathala / i-asthenia, isicanucanu, ukuqunjelwa, isifo sohudo, ukuncipha kwesifiso sokudla, ukuqhuma, ukuhlanza, ukukhwehlela, i-dyspnea, i-pyrexia, i-alopecia, i-peripheral neuropathy, ukuvuvukala kwe-mucosal, i-stomatitis, ikhanda elibuhlungu, ukwehla kwesisindo, ubuhlungu besisu, i-arthralgia, i-myalgia, nokuqwashisa ukusabela okubi okujwayelekile okubikwe cishe ku-20% weziguli ezivivinyweni ze-pembrolizumab kuhlanganiswe ne-chemotherapy.
I-Pembrolizumab inikezwa njengokufakwa emthanjeni ngaphezu kwemizuzu engama-30 ngethamo lika-200 mg njalo emavikini amathathu noma 400 mg njalo emavikini ayisithupha ku-TNBC. Ekwelashweni kwe-neoadjuvant, i-pembrolizumab inikezwa ngokuhlangana ne-chemotherapy amasonto angama-24, bese njenge-ejenti eyodwa yokwelashwa kwe-adjuvant kuze kube amasonto angama-27.
