MSD’s Phase 3 study of lymphoma treatment meets primary endpoints

pharmafile | March 3, 2020 | News story | Manufacturing and Production B-cell lymphoma, classical Hodgkin Lymphoma, lymphoma 

MSD announced that its Phase 3 study of Keytruda (pembrolizumab) for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) met one of its dual primary endpoints of progression-free survival.

This was labbled the KEYNOTE-204 trial, which studied a random sample of 304 patients with relapsed or refractory cHL to receive either Keyruda or the anti-body drug conjugate Adcetris. In this trial, Keytruda demonstrated a significant and clinically meaningful improvement in progression-free survival compared with Adcetris.

Jonathan Cheng, Vice President of oncology clinical research at Merck Research Laboratories, said: “This data is strongly supportive of Keytruda’s current indication in cHL and we plan to file the results with regulatory authorities as quickly as is possible.”

MSD initially gained accelerated approval from the FDA back in 2017 for the treatment of adult and pediatric patients with refractory cHL, or patients relapsed after three or more years of therapy. This was based on Phase 2 results that showed Keytruda demonstrated a 69% response rate.

MSD is investigating Keytruda across a number of conditions and has three registrational trials investigating its treatment of cHL and mediastinal large B-Cell lymphoma.

Conor Kavanagh

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