Keytruda Monotherapy Demonstrates 35% Reduction in Risk of Disease Progression or Death in Phase 3 Trial for Relapsed/Refractory Classical Hodgkin Lymphoma

Reposted from: Immediate Pharma News

On May 13, MSD announced for the first time the clinical trial results of KEYNOTE-204, a Phase 3 clinical trial evaluating Keytruda for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In this pivotal study, Keytruda demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the dual primary endpoints. Keytruda reduced the risk of disease progression or death by 35%, showing a median PFS of 13.2 months compared to 8.3 months for patients receiving the current standard of care, brentuximab vedotin (BV). As previously stated, as KEYNOTE-204 serves as a pivotal confirmatory trial, the company plans to submit these data to global regulatory authorities this year.

KEYNOTE-204 is a randomized, open-label, Phase 3 clinical trial (NCT02684292) designed to evaluate the efficacy of Keytruda monotherapy versus brentuximab vedotin (BV), the current standard of care, in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The dual primary endpoints were progression-free survival (PFS) and overall survival (OS); key secondary endpoints included objective response rate (ORR), complete response rate (CR), and safety. The study enrolled 304 patients aged 18 years or older, who were randomized to receive either Keytruda (200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles) or brentuximab vedotin (1.8 mg/kg [maximum dose 180 mg per dose] administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles). According to the prespecified analysis plan, the other dual primary endpoint, OS, was not formally tested at this interim analysis.

In this study, Keytruda demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) (HR=0.65 [95% CI, 0.48–0.88; p=0.00271]), with a median PFS of 13.2 months compared to 8.3 months for patients treated with BV. The 1-year PFS rate was 53.9% for Keytruda versus 35.6% for BV. Furthermore, the objective response rate (ORR) was 65.6% for Keytruda and 54.2% for BV, with complete responses (CR) observed in 24.5% and 24.2% of patients, respectively, and partial responses (PR) observed in 41.1% and 30.1% of patients, respectively. The median duration of response was 20.7 months (range, 0.0+ to 33.2+) for Keytruda and 13.8 months (range, 0.0+ to 33.9+) for BV.

“These data are particularly meaningful because approximately 15% to 20% of patients with classical Hodgkin lymphoma (the most common type of Hodgkin lymphoma) typically fail to achieve remission after first-line therapy. The KEYNOTE-204 data suggest that Keytruda monotherapy has the potential to change the current treatment paradigm for these patients, who are generally younger and face a poor prognosis when they do not achieve remission,” said John Kuruvilla, Hematologist and Associate Professor of Medicine at the Princess Margaret Cancer Centre and the University of Toronto.

References:

[1] Merck’s KEYTRUDA® (pembrolizumab) Superior to Brentuximab Vedotin (BV), a Standard of Care, in Patients With Classical Hodgkin Lymphoma (cHL) in Head-to-Head Phase 3 Trial. Retrieved 2020-05-14, from https://www.businesswire.com/news/home/20200513005705/en

Original Title: Positive Key Phase 3 Clinical Results for Keytruda Monotherapy in Hodgkin Lymphoma, Reducing Mortality Risk by 35%

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