This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) (NCT04003610), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04003610 |
| Phase | Phase 2 |
| Condition | Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Incyte Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with metastatic or unresectable urothelial carcinoma who were ineligible for cisplatin, whose tumors had an FGFR3 mutation or rearrangement, and who had not received prior treatment. The primary analysis population was defined as all participants randomized into the study, with treatment groups based on assignment at randomization.
Intervention
The experimental strategies were pemigatinib alone and pemigatinib plus pembrolizumab. The combination regimen used pemigatinib 13.5 mg once a day orally and pembrolizumab 200 mg every 3 weeks intravenously. Pemigatinib alone was listed as 13.5 mg once a day orally.
Comparator
The standard-of-care group could receive gemcitabine plus carboplatin or pembrolizumab. The record describes gemcitabine administration and a carboplatin target exposure, but the posted regimen description is incomplete. It does not report how participants were assigned between the standard-care options.
Primary question
The primary endpoint was progression-free survival, measured from randomization until disease progression assessed by blinded independent central review using RECIST v1.1, or death from any cause, whichever occurred first. The registry record reports median PFS of 1.81 months for pemigatinib plus pembrolizumab and 2.12 months for standard care. The pemigatinib-alone median is not reported as an estimable value.
The study was intended to evaluate efficacy and safety across the three strategies. The registry record does not provide a treatment-effect estimate comparing the groups, such as a hazard ratio, or a complete set of uncertainty intervals for the medians. The reported values therefore describe the posted group-level results; they do not establish whether observed differences are attributable to treatment, chance, or other features of the small set of participants.
3. Trial Design
FIGHT-205 was a randomized, open-label, multicenter, parallel-group phase 2 study. Its official title describes first-line treatment for metastatic or unresectable urothelial carcinoma in participants who were ineligible for cisplatin and whose tumors expressed an FGFR3 mutation or rearrangement. The brief description also specifies no prior treatment. The study status is terminated. The registry records a start date of 2020-05-14 and a primary completion date of 2021-04-18.
The planned comparison involved pemigatinib plus pembrolizumab, pemigatinib alone, and standard of care. The registry lists pemigatinib 13.5 mg once a day orally for the monotherapy group. The combination group used the same pemigatinib regimen with pembrolizumab 200 mg every 3 weeks intravenously. Standard care could be gemcitabine plus carboplatin or pembrolizumab. The posted description includes gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 and a carboplatin target exposure, but the regimen text ends before the full dosing description is complete.
Masking was listed as none, so the study was open-label. Random allocation and a parallel model are recorded, but the registry record does not report details such as the allocation procedure, concealment, or stratification factors. Enrollment was 7. The posted PFS results include 1 participant in the combination group, 6 in the standard-care group, and no participants in the pemigatinib-alone group. These are the group counts associated with the reported endpoint results, not evidence of a fully populated three-group comparison.
The primary endpoint was PFS, and the registry lists 9 outcome measures, including 8 secondary outcomes. These include overall survival, objective response, duration of response, adverse events, and patient-reported quality-of-life measures. No analysis records are listed. The registry record does not explain why the study was terminated or provide a detailed account of recruitment, treatment exposure, or follow-up by group.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Pemigatinib 13.5 mg | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg |
|---|---|---|---|
| STARTED | 0 | 1 | 6 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 1 | 6 |
Reasons for not completing this period:
| Reason | Pemigatinib 13.5 mg | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg |
|---|---|---|---|
| Lost to Follow-up | 0 | 1 | 0 |
| Death | 0 | 0 | 3 |
| Study Terminated by Sponsor | 0 | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (ITT) Population: all participants who were randomized into the study. Treatment groups for this population were to be determined according to the treatment assignment at the time of randomization. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: No participants were enrolled in the pemigatinib 13.5 mg treatment arm.
| Characteristic | Unit | Pemigatinib 13.5 mg | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 0 | 1 | 6 | 7 | |
| Age, Customized: 57 to 84 years old | Participants | 0 | 1 | 6 | 7 |
| Sex: Female, Male: Female | Participants | — | NA | 4 | NA |
| Sex: Female, Male: Male | Participants | — | NA | 2 | NA |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | — | NA | 0 | NA |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | — | NA | 5 | NA |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | — | NA | 1 | NA |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — | NA | 0 | NA |
| Race (NIH/OMB): Asian | Participants | — | NA | 3 | NA |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — | NA | 0 | NA |
| Race (NIH/OMB): Black or African American | Participants | — | NA | 0 | NA |
| Race (NIH/OMB): White | Participants | — | NA | 3 | NA |
| Race (NIH/OMB): More than one race | Participants | — | NA | 0 | NA |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — | NA | 0 | NA |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS), measured over up to 130 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from randomization until disease progression or death, whichever happens first. In this study, progression was assessed by blinded independent central review according to RECIST v1.1. The endpoint therefore combines radiographic progression and death into a time-to-event outcome. A participant who experiences either event has reached the endpoint; participants without a recorded event would generally contribute follow-up until their last relevant assessment, subject to the analysis rules.
PFS is used in clinical trials because it captures how long participants remain alive without documented progression. It can be informative when disease control is a key study question, and it does not require a death to occur for an endpoint event to be observed. Central review can provide an assessment separate from the treating team, while the study’s open-label design means participants and clinical teams were not masked to treatment assignment. The registry record does not describe further procedures for reconciling assessments or handling missed scans.
The posted endpoint is a median, a summary of the event-time distribution rather than a mean or a direct measure of individual benefit. The record specifies a timeframe of up to 130 days. It reports a median of 1.81 months for the combination group and 2.12 months for standard care, with incomplete interval reporting. No estimable median is posted for pemigatinib alone. These summaries cannot by themselves indicate how the full survival curves compare or quantify a relative treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The PFS results need to be read in the context of the group sizes represented in the posted outcome data. The combination group has a reported median of 1.81 months based on 1 participant. Standard care has a reported median of 2.12 months based on 6 participants. The pemigatinib-alone group has 0 participants in the posted results and no median estimate. With this sparse information, the values are descriptive and do not support a reliable comparative conclusion.
The registry reports a 95% confidence interval for the standard-care median with a lower limit of 1.51 months, but no upper limit is posted. No confidence limits are reported for the combination median. The absence of interval limits is important: a point estimate alone does not show the precision of an estimate. The registry record also does not report a hazard ratio or another comparative effect estimate. Accordingly, there is no posted measure that quantifies the relative PFS experience between treatment groups while accounting for event timing across follow-up.
A median can be affected substantially by the event times of a small number of participants. It does not reveal the distribution of times before or after the midpoint, the number of censored observations, or whether the event patterns differed over follow-up. Those details are not reported in the registry record. A numerical difference between the posted medians should not be calculated or treated as evidence of superiority; the small and imbalanced group counts and incomplete uncertainty information make such a reading especially fragile.
The study was randomized, but the posted results do not show a completed comparison across all three planned arms. The pemigatinib-alone arm has no participants represented in the PFS results. The standard-care arm may include different treatment options, and the record does not state which option each participant received. The results therefore cannot distinguish outcomes by the standard-care regimen. Nor does the registry record explain whether termination affected enrollment, treatment exposure, follow-up, or the intended analysis.
Safety findings also require caution. One participant in the combination group was at risk for serious adverse events and one was reported as affected; in standard care, 6 were at risk and 1 was reported as affected. There were no participants at risk in the pemigatinib-alone group. The record reports 3 deaths in standard care and none in the combination group, but does not establish whether those deaths were caused by treatment or provide further context for their timing. These small counts are descriptive, not stable estimates of comparative risk.
Overall, the registry supports a limited description of recorded PFS and safety outcomes. It does not provide enough information for a robust estimate of comparative efficacy, precision, or treatment-related harm. No treatment should be judged effective or ineffective from these posted results alone.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure, and the registry reports group medians with 95% confidence intervals. Time-to-event methods are designed for outcomes where the event may occur at different times and where some participants may not have an event recorded during their observed follow-up. This approach can use information about when events occur, rather than reducing each participant’s course to a simple event/no-event summary. The record does not provide the event and censoring details needed to reconstruct those analyses.
What does the median PFS represent?
The median is the point in the estimated event-time distribution at which half of the distribution is on either side. It is a location summary, not a comparison statistic. It does not state how much one treatment changes PFS relative to another, and it does not describe the shape of the event-time curve. When the underlying group is very small, the median can be determined by very limited information and may be imprecise. Here, the posted result for the combination group is based on 1 participant, and the standard-care result is based on 6. No median is posted for pemigatinib alone.
What does a confidence interval convey?
A confidence interval represents uncertainty around an estimate under the statistical method used to construct it. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. For this endpoint, the registry says the 95% confidence intervals were calculated using the Brookmeyer and Crowley method. The standard-care result includes a lower limit of 1.51 months but no upper limit; the combination result has no limits posted. Thus, the record does not give complete interval estimates for comparing the reported medians. An interval around a median is not itself a test of the difference between treatment groups.
Why is a hazard ratio not interchangeable with a median?
A hazard ratio compares event rates over follow-up under a time-to-event model; a median describes a single location in each group’s event-time distribution. The two summaries answer different questions and rely on different information. The registry record does not report a hazard ratio for PFS. It therefore provides no posted relative-effect estimate of that kind. A hazard ratio should not be inferred from the medians, particularly when the group counts are sparse and interval reporting is incomplete.
What is the role of the analysis population?
The primary outcome description defines the intent-to-treat population as all participants randomized, with groups assigned according to the treatment assignment at randomization. This definition preserves the randomized comparison in principle, even if participants do not follow the assigned treatment exactly. The registry reports 7 enrolled participants, while the posted PFS groups include 1 in the combination arm, 6 in standard care, and 0 in pemigatinib alone. The record does not explain the relationship between enrollment and these outcome counts, or provide participant-level disposition and analysis details. The reported group counts should therefore be read as the counts attached to these posted results.
How should the planning illustrations be understood?
The registry record’s planning description characterizes sample-size values as illustrations computed from an observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the described quantity is the total number of events using the Schoenfeld approach; for other outcomes, it is participants per arm. Such planning calculations ask what sample size might be needed under assumed conditions. They are not observed power, do not establish that the original study was adequately planned, and cannot replace a documented sample-size justification. The registry record does not report the trial’s own sample-size justification.
These methods have limitations in this record because the reported groups are small, the arm counts are uneven, one planned arm has no participants in the posted PFS results, and the uncertainty reporting is incomplete. The registry record does not report the analysis model beyond the median endpoint and confidence-interval method. It also does not provide a detailed statistical analysis plan, interim-analysis information, or a comparative hypothesis test. No additional model, adjustment, or inferential result should be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The study lists PFS as the primary outcome and includes secondary outcomes such as overall survival, objective response rate, duration of response, treatment-emergent adverse events, and quality-of-life measures. The registry record lists 9 outcome measures and 8 secondary outcomes. It does not report how the family of outcomes was handled statistically: no multiplicity adjustment, testing hierarchy, or prespecified order of interpretation is described. When many outcomes are assessed, the chance of finding at least one apparently notable result can increase if results are interpreted without accounting for the number of comparisons. That is a general statistical concern, not evidence that any particular adjustment was or was not used in the study.
The registry has no analysis records listed, and the posted results do not include estimates for all listed outcomes. For PFS, the pemigatinib-alone median is absent, the combination interval is absent, and the standard-care interval has only a lower limit. Missing results are not evidence of a zero effect or of no events; they leave the corresponding quantities unknown. Reasons for unavailable or non-estimable results are not reported in the registry record.
The primary outcome population is described as intent-to-treat, including all randomized participants according to assigned group. However, the record does not provide participant flow, withdrawals, reasons for missing assessments, censoring counts, or the handling of missing outcome information. It also does not report whether analyses of secondary outcomes used different populations. The extent to which incomplete information could affect the estimates therefore cannot be assessed from the registry record.
The study is listed as terminated, but the reason for termination and its consequences for the analysis are not reported in the registry record. The record also does not report interim analyses or a detailed statistical analysis plan. In their absence, the intended handling of multiplicity, missingness, and any planned comparisons cannot be established.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | 1 | 1 | 100.0% |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pemigatinib 13.5 mg | 0 of 0 |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | 0 of 1 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | 3 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pemigatinib 13.5 mg | 0 of 0 |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | 1 of 1 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Pemigatinib 13.5 mg | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg |
|---|---|---|---|---|
| Bone pain | Musculoskeletal and connective tissue disorders | n/a of 0 | 1 of 1 | 0 of 6 |
| COVID-19 | Infections and infestations | n/a of 0 | 0 of 1 | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pemigatinib 13.5 mg | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg |
|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | n/a of 0 | 0 of 1 | 3 of 6 |
| Alanine aminotransferase increased | Investigations | n/a of 0 | 1 of 1 | 1 of 6 |
| Asthenia | General disorders | n/a of 0 | 0 of 1 | 2 of 6 |
| Blood alkaline phosphatase increased | Investigations | n/a of 0 | 0 of 1 | 2 of 6 |
| Malaise | General disorders | n/a of 0 | 0 of 1 | 2 of 6 |
| Nausea | Gastrointestinal disorders | n/a of 0 | 0 of 1 | 2 of 6 |
| Abdominal pain | Gastrointestinal disorders | n/a of 0 | 0 of 1 | 1 of 6 |
| Anaemia | Blood and lymphatic system disorders | n/a of 0 | 0 of 1 | 1 of 6 |
| Aspartate aminotransferase increased | Investigations | n/a of 0 | 1 of 1 | 0 of 6 |
| Bone pain | Musculoskeletal and connective tissue disorders | n/a of 0 | 0 of 1 | 1 of 6 |
Serious events with the highest arm-level rate: bone pain (100.0%), covid-19 (16.7%).
The adverse-event figures are counts among the participants listed as at risk for each group. In the combination group, 1 participant was at risk for serious adverse events and 1 was reported as affected. In standard care, 6 participants were at risk and 1 was reported as affected. The pemigatinib-alone group had 0 participants at risk and 0 affected. These counts describe what was recorded in each group; they are not precise comparative estimates, especially with such small denominators.
The registry lists 3 deaths in standard care and 0 in the combination group, with none listed for pemigatinib alone. It does not provide enough context to attribute deaths to treatment, to classify their timing, or to establish the cause. Serious adverse events and deaths should not be treated as interchangeable outcomes.
The record also lists bone pain at 100.0% and COVID-19 at 16.7% among the top serious-event terms. The precise denominator and group context for these percentages are not clear in the posted information. They should not be read as comparative rates across the treatment groups. The record does not provide event-level details, severity grading, duration, or a full breakdown that would support a more detailed safety comparison.
12. What the Result Does, and Does Not, Mean
The registry results describe a small, incomplete set of outcomes from a randomized study of pemigatinib-based strategies and standard care. The primary endpoint was PFS, and the record reports medians for the combination and standard-care groups. It does not report an estimable pemigatinib-alone median, complete confidence intervals, or a hazard ratio. The observed medians are therefore not a basis for concluding that one strategy produced longer PFS than another.
Randomization is an important design feature because it is intended to support fair comparisons between groups. But randomization alone does not make a very small, incomplete set of results conclusive. The posted PFS groups are highly limited in size, and the record provides no complete three-arm comparison. The standard-care category may combine more than one treatment option, with no regimen-specific outcomes reported. The results cannot resolve differences between those options.
The safety counts are similarly descriptive. They show reported serious adverse events and deaths in the groups represented, but the counts are too limited to characterize comparative risks with precision. The record does not establish causation for deaths or provide enough information to interpret the serious-event terms by group.
These findings do not prove that a treatment works or does not work. They also do not establish equivalence, noninferiority, or a clinically meaningful benefit or harm. Such conclusions require a suitable comparative estimate, sufficient information to assess its uncertainty, and transparent reporting of the analysis. The registry record does not include those elements for this PFS comparison.
The trial remains relevant as a record of a planned randomized evaluation in a defined clinical population. Its posted results mainly illustrate why group counts, completeness of follow-up, and uncertainty estimates matter when interpreting trial outcomes. Any broader conclusion about treatment should not be drawn from these registry data alone.
13. Why This Trial Matters Statistically
This trial raises core statistical issues that arise when a randomized study has very limited posted outcome data. The registry describes a three-arm design, but the PFS results include participants in only two groups, with no participants represented in the pemigatinib-alone endpoint result. The reported medians are based on very small group counts, and complete confidence intervals are not available. These features make it essential to distinguish a descriptive summary from a comparative estimate.
It also demonstrates that a median is not a substitute for a treatment-effect measure. A median gives a summary location for each group’s event-time distribution, while a hazard ratio or another comparison directly addresses relative outcomes under a specified analysis. The record does not report a comparative PFS estimate. It is therefore not possible to assess the magnitude and precision of a treatment contrast from the posted summaries.
Endpoint interpretation also depends on what was measured and how. PFS combines progression, assessed by blinded independent central review using RECIST v1.1, with death from any cause. This makes the endpoint definition explicit, but interpretation still requires information about event timing, follow-up, and censoring. Those details are not reported in the registry record.
Finally, the study’s termination status, absence of analysis records, and incomplete reporting of uncertainty underscore the importance of transparent registry results. The record states that planning illustrations use assumptions and are not the trial’s own design justification. Keeping planning calculations separate from observed outcomes avoids confusing a hypothetical sample-size exercise with evidence about the trial’s actual precision or power. Overall, the statistical value of the record lies in clarifying both the intended question and the limits of what the posted results can answer.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is the small number of participants represented in the posted PFS results: 1 in the combination group and 6 in standard care, with 0 in the pemigatinib-alone group. The study’s recorded enrollment is 7, but the registry does not provide a detailed participant flow to explain the endpoint counts. With so few observations, the median estimates and safety counts are highly sensitive to the experience of individual participants.
Uncertainty reporting is incomplete. The combination median has no confidence limits posted, the standard-care interval has a lower limit but no upper limit, and no median is posted for pemigatinib alone. No hazard ratio or other comparative PFS estimate is reported. The registry record therefore does not allow readers to assess the precision of a full treatment comparison.
The standard-care group could receive gemcitabine plus carboplatin or pembrolizumab, but the results do not separate outcomes by regimen. The posted dosing description for gemcitabine and carboplatin is incomplete. This limits interpretation of what standard care represents for the participants in the results.
The record does not report reasons for termination, participant-level follow-up, censoring information, missing assessments, or detailed analysis methods. It also does not provide a statistical analysis plan, interim-analysis information, or multiplicity procedures. The safety information lacks sufficient detail to assess event timing, severity, attribution, or percentage denominators for the listed serious-event terms.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) — NCT04003610.
- Registry record last updated 2025-11-04; status last verified 2025-10.
- Results first posted 2022-05-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
FIGHT-205 was a randomized, open-label, multicenter phase 2 study with a parallel design. It evaluated pemigatinib plus pembrolizumab, pemigatinib alone, and standard care in cisplatin-ineligible participants with metastatic or unresectable urothelial carcinoma and FGFR3 mutation or rearrangement. The registry lists enrollment of 7, status as terminated, a start date of 2020-05-14, and a primary completion date of 2021-04-18.
The primary outcome was PFS, defined as time from randomization to progression by blinded independent central review using RECIST v1.1 or death, whichever came first. The posted median was 1.81 months for the combination group and 2.12 months for standard care; no median was posted for pemigatinib alone. The small group counts and incomplete uncertainty reporting limit interpretation. The registry lists 8 secondary outcomes and no analysis records.