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Pembrolizumab yields positive outcomes in trials for melanoma, NSCLC
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The addition of pembrolizumab to pemetrexed and cisplatin or carboplatin improved OS and PFS as first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer, according to results from the phase 3 KEYNOTE-189 trial.
Merck also announced that the phase 3 EORTC1325/KEYNOTE-054 trial of pembrolizumab (Keytruda) reached its primary endpoint of improved RFS compared with placebo among patients with surgically resected high-risk melanoma.
In the KEYNOTE-189 trial — which included 614 patients with advanced or metastatic nonsquamous NSCLC, regardless of PD-L1 expression, who had no EGFR or ALK mutations and had not previously received systemic therapy for advanced disease — pembrolizumab in combination with pemetrexed (Alimta, Eli Lilly) and platinum chemotherapy met its dual primary endpoints of OS and PFS compared with chemotherapy alone. The safety profile appeared consistent with previous observations.
“KEYNOTE-189 showed significant improvement in [OS] and [PFS] for patients receiving Keytruda in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “We are deeply grateful to the KEYNOTE-189 patients and investigators for their important contributions to this landmark study, and we look forward to presenting the data in the near future.”
In the EORTC1325/KEYNOTE-054 trial, researchers evaluated IV 200 mg pembrolizumab every 21 days for up to a year as adjuvant therapy compared with placebo for 1,019 patients with resected high-risk melanoma (stages IIIa, IIIb and IIIc).
RFS served as the primary endpoint. Secondary endpoints included distant metastases-free survival and OS.
Results showed pembrolizumab significantly prolonged RFS (HR = 0.57, 98.4% CI, 0.43-0.74) compared with placebo.
“This result shows a significant advancement for patients that could potentially change the way melanoma is treated in the future,” Alexander Eggermont, MD, PhD, director general at the Gustave Roussy Cancer Institute and professor of oncology at University of Paris-Saclay, said in a manufacturer-issued press release.
Results from both studies will be submitted to regulatory authorities.