Across 224 CTIS phase-listed European lymphoma Phase II and Phase III trial entries from 2024–2026, the most frequently measured endpoint families were overall survival (OS) in 173 entries (77.2%), safety/adverse events in 167 (74.6%), progression-free survival (PFS) in 165 (73.7%), objective/overall response rate (ORR) in 157 (70.1%), and complete response/remission in 151 (67.4%). The endpoint strategy differs sharply by phase: Phase II primary endpoints are response-led, while Phase III primary endpoints are dominated by PFS.
OS was the most frequently measured endpoint family, appearing in 173 of 224 CTIS entries (77.2%). Safety/adverse events followed closely at 167 entries (74.6%), PFS at 165 (73.7%), ORR at 157 (70.1%), and complete response/remission at 151 (67.4%). Endpoint categories are trial-level presences and can overlap when one endpoint measures several related constructs.
European lymphoma CTIS submissions are not dominated by a single endpoint; they use a dense efficacy-and-safety package. OS, safety, PFS, ORR, and CR/CRR each appear in more than two-thirds of entries, suggesting that even response-driven lymphoma programs routinely retain survival and safety endpoints for regulatory comparability.
Primary endpoint fields were present in 210 of 224 entries (93.8%), secondary endpoint fields in 195 (87.1%), and formal other/exploratory endpoint fields in 11 (4.9%). Primary endpoints were led by complete response/remission in 75 entries (33.5%), PFS in 72 (32.1%), ORR in 67 (29.9%), and safety in 60 (26.8%). Secondary endpoints were led by OS in 169 entries (75.4%) and safety in 139 (62.1%).
The primary endpoint layer is split between response and time-to-event efficacy, while the secondary layer carries the broader regulatory evidence package. Formal exploratory endpoint fields are rare in CTIS lymphoma records, but biomarker, pharmacodynamic, QoL, and MRD concepts still appear frequently inside secondary endpoint structures.
The cohort contained 151 Phase II-listed entries (67.4%) and 73 Phase III-listed entries (32.6%). In Phase II, primary endpoints were response-led: CR/CRR appeared in 69 of 151 entries (45.7%), ORR in 60 (39.7%), and safety in 55 (36.4%). In Phase III, PFS became the dominant primary endpoint, appearing in 48 of 73 entries (65.8%), ahead of OS in 18 (24.7%).
| Endpoint family | Phase II | Phase III |
|---|---|---|
| PFS | 24/151 (15.9%) | 48/73 (65.8%) |
| CR/CRR | 69/151 (45.7%) | 6/73 (8.2%) |
| ORR | 60/151 (39.7%) | 7/73 (9.6%) |
| Safety / AEs | 55/151 (36.4%) | 5/73 (6.8%) |
| OS | 13/151 (8.6%) | 18/73 (24.7%) |
Phase II lymphoma submissions emphasize early efficacy and tolerability signals, especially CR/CRR, ORR, and safety. Phase III submissions shift toward comparative time-to-event evidence, with PFS appearing as a primary endpoint family in nearly two-thirds of Phase III entries.
Subtype mentions were sufficient for comparison in diffuse large B-cell / large B-cell lymphoma (72 entries), Hodgkin lymphoma (58), CLL/SLL (45), follicular lymphoma (45), mantle cell lymphoma (31), T-cell lymphoma (22), and marginal zone lymphoma (15). Because some CTIS disease fields include multiple lymphoma diagnoses, subtype groups are mention-based and can overlap.
| Subtype | n | Most frequent endpoint families |
|---|---|---|
| DLBCL / large B-cell | 72 | PFS 57 (79.2%); OS 55 (76.4%); ORR 53 (73.6%); CR 53 (73.6%) |
| Hodgkin lymphoma | 58 | OS 44 (75.9%); safety 43 (74.1%); PFS 40 (69.0%); ORR 39 (67.2%) |
| CLL/SLL | 45 | Safety 34 (75.6%); PFS 33 (73.3%); ORR 33 (73.3%); OS 33 (73.3%) |
| Follicular lymphoma | 45 | CR 38 (84.4%); ORR 37 (82.2%); OS 36 (80.0%); PFS 35 (77.8%) |
| Mantle cell lymphoma | 31 | PFS 23 (74.2%); safety 23 (74.2%); ORR 22 (71.0%); CR 22 (71.0%) |
| T-cell lymphoma | 22 | CR 19 (86.4%); OS 18 (81.8%); ORR 17 (77.3%); safety 16 (72.7%) |
| Marginal zone lymphoma | 15 | CR 14 (93.3%); PFS 13 (86.7%); OS 13 (86.7%); safety 12 (80.0%) |
Across lymphoma subtypes, the common evidence package remains stable: response, PFS, OS, and safety dominate. The clearest subtype-specific signal is that follicular, T-cell, and marginal zone lymphoma entries are especially response/remission-heavy, while DLBCL / large B-cell entries are more PFS-led.
Modality comparisons were numerically strongest for small molecules (158 entries), monoclonal antibodies (130), bispecific antibodies (44), cell therapy (32), and antibody-drug conjugates (ADCs; 27). Small-molecule and monoclonal-antibody entries were PFS-led at the primary endpoint level, while cell-therapy entries had the strongest primary safety signal.
| Modality | n | Leading primary endpoint families |
|---|---|---|
| Small molecule | 158 | PFS 65 (41.1%); ORR 42 (26.6%); CR 42 (26.6%) |
| Monoclonal antibody | 130 | PFS 52 (40.0%); CR 35 (26.9%); ORR 31 (23.8%) |
| Bispecific antibody | 44 | CR 14 (31.8%); ORR 12 (27.3%); safety 12 (27.3%) |
| Cell therapy | 32 | Safety 15 (46.9%); ORR 12 (37.5%); CR 12 (37.5%) |
| ADC | 27 | CR 11 (40.7%); ORR 9 (33.3%); PFS 8 (29.6%) |
Endpoint selection is partly modality-sensitive. Small-molecule and antibody programs look closer to conventional late-stage lymphoma designs with PFS prominent as a primary endpoint, while cell therapy and ADC entries retain stronger early efficacy and safety orientation.
All 224 entries were grouped by first CTIS authorization year: 168 entries were authorized in 2024, 47 in 2025, and 9 in 2026. The median interval from initial CTIS submission to first authorization was 55 days overall. The median interval was 54 days for Phase II entries and 60 days for Phase III entries.
For EU lymphoma submissions in this dataset, Phase III authorization timing was only modestly longer than Phase II. This suggests that endpoint complexity alone does not strongly separate CTIS processing timelines between Phase II and Phase III lymphoma programs.
The same CTIS endpoint data can answer several adjacent questions numerically: how often lymphoma trials include patient-reported outcomes, how often MRD is used, how often pharmacokinetics and immunogenicity are measured, and whether orphan or pediatric entries differ from the adult/non-orphan endpoint pattern.
The dataset supports more than endpoint ranking: it also quantifies the penetration of patient-reported, molecular, PK, immunogenicity, orphan, and pediatric endpoint strategies. These are useful adjacent angles for EU submission planning because they show which supportive measures are becoming common in CTIS lymphoma dossiers.
PFS = progression-free survival; OS = overall survival; ORR = objective or overall response rate; CR/CRR = complete response or complete response rate; DOR = duration of response; EFS = event-free survival; MRD = measurable or minimal residual disease; QoL = quality of life; PRO = patient-reported outcome; PK = pharmacokinetics; ADA = anti-drug antibody; ADC = antibody-drug conjugate; CTIS = Clinical Trials Information System.