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On March 18, 2021, it was announced that the European Commission (EC) approved pembrolizumab, an anti-PD-1 monoclonal antibody, for the treatment of adult and pediatric patients (≥3 years of age) with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). This approval is for patients who have failed autologous hematopoietic stem cell transplant (auto-HSCT) or failed ≥2 prior therapies when auto-HSCT is not a treatment option.1
This approval was based on data from the interim analysis of the phase III KEYNOTE-204 trial (NCT02684292) previously discussed by John Kuruvilla at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. These results have recently been published in The Lancet Oncology and are summarized below.2 The EC approval was also based on supportive data from an updated analysis of the phase II KEYNOTE‑087 trial (NCT02453594), previously reported on the Lymphoma Hub.
Table 1. Response in the pembrolizumab cohort vs BV cohort*
Response† |
Pembrolizumab (n = 151) |
BV (n = 153) |
---|---|---|
ORR, % |
66 |
54 |
CR |
25 |
24 |
PR |
41 |
30 |
SD, % |
14 |
24 |
PD, % |
17 |
18 |
mDOR, months (95% CI) |
20.7 (12.4–not reached) |
13.8 (5.8–not reached) |
BV, brentuximab vedotin; CR, complete response; mDOR, median duration of response, ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease. |
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