Response characteristics and immune-mediated AEs and infusion reactions in patients treated with second pembrolizumab course
| Cohort/patient no.* . | DOR, 1st course . | BOR, 2nd course† . | DOR, 2nd course . | Response on 2nd course . | Reason for 2nd course discontinuation . | Immune-mediated AEs and infusion reactions‡ . | |
|---|---|---|---|---|---|---|---|
| 1st course . | 2nd course . | ||||||
| Cohort 1 | |||||||
| 1 | 23.5 | NA§ | — | — | — | Uveitis | — |
| 3 | 14.5 | PR | 5.6 | Ongoing | — | — | — |
| 4 | 18.0 | NA§ | — | — | — | — | — |
| 6 | 10.8 | PR | 6.9 | — | Clinical progression | — | — |
| 8 | 8.3 | CR | 11.3 | Ongoing | Completed | Infusion reactions | — |
| 7¶ | 11.0 | PD | 5.3 | — | PD | — | — |
| Cohort 2 | |||||||
| 2 | 5.0 | CR | 8.3 | Ongoing | — | Sarcoidosis | Sarcoidosis |
| 10 | 8.3 | CR | 0.7 | — | AE | Pancreatitis | — |
| 9 | 5.3 | CR | 11.2 | Ongoing | Completed | Colitis | — |
| Cohort 3 | |||||||
| 5 | 7.1 | SD | 11.0 | — | Completed | — | — |
| Cohort/patient no.* . | DOR, 1st course . | BOR, 2nd course† . | DOR, 2nd course . | Response on 2nd course . | Reason for 2nd course discontinuation . | Immune-mediated AEs and infusion reactions‡ . | |
|---|---|---|---|---|---|---|---|
| 1st course . | 2nd course . | ||||||
| Cohort 1 | |||||||
| 1 | 23.5 | NA§ | — | — | — | Uveitis | — |
| 3 | 14.5 | PR | 5.6 | Ongoing | — | — | — |
| 4 | 18.0 | NA§ | — | — | — | — | — |
| 6 | 10.8 | PR | 6.9 | — | Clinical progression | — | — |
| 8 | 8.3 | CR | 11.3 | Ongoing | Completed | Infusion reactions | — |
| 7¶ | 11.0 | PD | 5.3 | — | PD | — | — |
| Cohort 2 | |||||||
| 2 | 5.0 | CR | 8.3 | Ongoing | — | Sarcoidosis | Sarcoidosis |
| 10 | 8.3 | CR | 0.7 | — | AE | Pancreatitis | — |
| 9 | 5.3 | CR | 11.2 | Ongoing | Completed | Colitis | — |
| Cohort 3 | |||||||
| 5 | 7.1 | SD | 11.0 | — | Completed | — | — |
BOR, best overall response; NA, not applicable.
Per duration of response graph (Figure 4).
By site review per International Working Group Revised Response Criteria for Malignant Lymphoma.
Based on a list of terms specified by the sponsor and included by the investigator, regardless of attribution to study treatment or immune relatedness; related terms are included.
At data cutoff, 2 patients had recently started a second course of pembrolizumab, and response assessment had not yet occurred.
Patient had an AE of pericarditis during the first course of pembrolizumab treatment that also occurred during the second course of treatment and was considered by the investigator to be immune-related.