KEYNOTE-170
KEYNOTE-170 showed that a PD-1 antibody works in primary mediastinal B-cell lymphoma, whose cells carry extra copies of the PD-L1 gene: almost half of heavily treated patients responded, which led to the first drug approval specific to this lymphoma.
Overview
KEYNOTE-170 treated 53 patients with relapsed or refractory primary mediastinal large B-cell lymphoma with pembrolizumab 200 mg every three weeks for up to two years. The disease is defined by gains and rearrangements of the 9p24.1 locus that carries PD-L1, PD-L2 and JAK2, the same lesion that makes classical Hodgkin lymphoma so sensitive to PD-1 blockade.
The objective response rate was 45 percent with 13 percent complete responses, and responses were durable, with the median duration not reached at a median follow-up of over a year. Together with the KEYNOTE-013 cohort this supported FDA accelerated approval in June 2018 for patients who had relapsed after two or more lines, the first approval of any drug specifically for this lymphoma.
CheckMate 436 later combined nivolumab with brentuximab vedotin in the same setting with a higher response rate, and CD19 CAR-T products licensed for large B-cell lymphoma include primary mediastinal disease in their labels.
- 45 out of 100 people had their tumour shrink with Pembrolizumab.
- 13 out of 100 people had their tumour shrink with Pembrolizumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Relapsed or refractory primary mediastinal large B-cell lymphoma after autologous transplant, or ineligible for it after two or more lines: pembrolizumab monotherapy. People in a different situation may not see the same effect.
- Only 53 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
53 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Pembrolizumab | 53 | 45% | - | - | link |
| Complete response rate | Pembrolizumab | 53 | 13% | - | - | link |
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