![]() Median follow-up was approximately 44 months in both groups. In KEYNOTE-355, 847 patients were randomized 2:1 to receive either pembrolizumab plus chemotherapy, or placebo plus chemotherapy. Still, ESMO discussant Gonzalo Gomez-Abuin, MD, of Hospital Alemán in Buenos Aires, agreed with Rugo, and called the regimen a "transformative treatment." ![]() There was no added benefit with pembrolizumab when applying a cutoff of CPS ≥1, however. "These results support pembrolizumab/chemotherapy as a new standard-of-care treatment regimen for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 with CPS ≥10," she said in a presentation at the European Society for Medical Oncology (ESMO) virtual meeting. ![]() PFS results led to accelerated approval of the combination last year, which was recently converted to full FDA approval. Rugo said updated progression-free survival (PFS) results in the CPS ≥10 group were consistent with those previously reported, with 65.5% in the pembrolizumab group and 78.6% in the placebo group experiencing a PFS event at data cutoff (HR 0.66, 95% CI 0.50-0.88). ![]()
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