{"id":325722,"date":"2022-05-24T01:00:00","date_gmt":"2022-05-23T23:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/regulatory-extension-for-anti-pd-1-therapy-with-pembrolizumab\/"},"modified":"2022-05-24T01:00:00","modified_gmt":"2022-05-23T23:00:00","slug":"regulatory-extension-for-anti-pd-1-therapy-with-pembrolizumab","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/regulatory-extension-for-anti-pd-1-therapy-with-pembrolizumab\/","title":{"rendered":"Regulatory extension for anti-PD-1 therapy with pembrolizumab"},"content":{"rendered":"

Swissmedic has granted a further marketing authorization for anti-PD-1 therapy with pembrolizumab. This can now be approved in combination with chemotherapy in Switzerland for the treatment of patients with locally recurrent, unresectable or metastatic triple-negative breast carcinoma whose tumors express PD-L1 (CPS \u226510) and who have not received prior chemotherapy for metastatic disease.<\/strong><\/p>\n

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In Switzerland, approximately 6350 people are diagnosed with breast cancer each year, and about 10-15% of them, mostly younger women, are diagnosed with triple-negative breast cancer (TNBC). For these indications, only a few targeted therapies are available so far. Now pembrolizumab (Keytruda\u00ae) has received a corresponding extension of approval. It may be used in combination with chemotherapy (paclitaxel (Pac), nab-paclitaxel, or gemcitabine\/carboplatin) to treat patients with locally recurrent, unresectable, or metastatic TNBC whose tumors express PD-L1 (CPS \u226510) and who have not received prior chemotherapy for metastatic disease.<\/p>\n

The approval is based on the results of KEYNOTE-3554, a multicenter, double-blind, randomized, placebo-controlled Phase III study of 847 patients with locally recurrent, unresectable or metastatic TNBC, without pretreatment of advanced disease with chemotherapy. Patients were randomized 2:1 to receive pembrolizumab 200 mg every three weeks in combination with chemotherapy or placebo in combination with chemotherapy via intravenous infusion. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary endpoints were ORR, DOR, DCR, and safety.<\/p>\n

Risk of progression and death reduced<\/h2>\n

It was shown that combination therapy resulted in a statistically significant, clinically meaningful improvement over placebo plus chemotherapy. The risk of progression and death was statistically significantly reduced by 34%, and the risk of death alone was reduced by 27%. The objective response rate was 53% vs. 41% and the duration of response was 12.8 months vs. 7.3 months.<\/p>\n

New safety signals were not detected. The most common adverse events were anemia (49%), neutropenia (41%), nausea (39%), alopecia (33%), fatigue (28%), decreased neutrophil count (22%), and increased alanine aminotransferase (20%). The most common immune-mediated adverse events observed in \u226510 patients receiving Keytruda\u00ae plus chemotherapy include hypothyroidism, hyperthyroidism, pneumonitis, colitis, and severe skin reactions. Thus, the safety profile corresponded to the known profiles of the individual drugs.<\/p>\n

Source: MSD Merck Sharp & Dohme<\/em><\/p>\n

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Further reading:<\/p>\n