Merck’s phase 3 trial of subcutaneous Pembrolizumab with Berahyaluronidase Alfa meets primary endpoints
Posted on November 25, 2024
Merck announces their new positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as KEYTRUDA , together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc.
This trial met its dual primary pharmacokinetic endpoints. Specifically, subcutaneous pembrolizumab administered every six weeks with chemotherapy demonstrated noninferiority of Area Under the Curve exposure of pembrolizumab during the first dosing cycle, and trough concentration of pembrolizumab measured at steady state, compared to IV KEYTRUDA administered every six weeks in combination with chemotherapy. Additionally, secondary endpoints of efficacy and safety were generally consistent for subcutaneous pembrolizumab administered with chemotherapy compared with IV KEYTRUDA administered with chemotherapy.
“KEYTRUDA has helped transform the way we treat some of the deadliest forms of cancer, yet we continue to pursue additional innovations that may benefit patients,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “It is very encouraging to see positive Phase 3 results evaluating this fixed-dose combination of subcutaneous pembrolizumab, which was administered, on average, in approximately 2-3 minutes and has the potential to improve the patient experience as well as increase access for patients and healthcare providers compared to intravenous administration. We plan to discuss these results with regulatory authorities worldwide as soon as possible.”
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a hyaluronidase variant developed and manufactured by Alteogen Inc. (MK-3475A; “subcutaneous pembrolizumab”), available for intravenous use as KEYTRUDA ®, KEYTRUDA, known as MSD outside of the United States and Canada, Merck (NYSE: MRK), Merck’s anti-PD-1 therapy, Phase 3 trial, today announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa
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