POD1UM-202
A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202)
Phase 2N = 94NCT03597295
- Population
- Patients aged 18 or older with measurable disease and squamous carcinoma of the anal canal who had progressed following, or were ineligible for, platinum-based therapy; 94 enrolled.
- Design
- Open-label, single-arm, multicentre phase II study. Retifanlimab 500 mg intravenously every 4 weeks. Primary endpoint: overall response rate by independent central review. Secondary endpoints: duration of response, disease control rate, progression-free survival, overall survival and safety.
- Primary endpoint
- ORR
- Arms
- Retifanlimab (experimental, n = 94): Retifanlimab 500 mg intravenously every 4 weeks
- People
- Rao S, senior author Spano JP
Show the numbers
| Endpoint | Analysis | Retifanlimab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled patients (n = 94) | primarymedian follow-up 7.1 monthsRao 2022 | 13.8% (7.6–22.5%) | — | One complete response (1.1%) and 12 partial responses (12.8%) by independent central review. Stable disease in 33 patients (35.1%) gave a disease control rate of 48.9% (95% CI 38.5-59.5). Responses were seen regardless of HIV or HPV status, PD-L1 expression or liver metastases. |
| DORResponders among 94 enrolled patients | primaryRao 2022 | median 9.5 months | — | The abstract gives a range of 5.6 months to not estimable rather than a confidence interval. |
| PFSAll enrolled patients (n = 94) | primaryRao 2022 | median 2.3 months (1.9–3.6) | — | — |
| OSAll enrolled patients (n = 94) | primaryRao 2022 | median 10.1 months | — | The 95% CI is 7.9 months to not estimable and cannot be stored. |
| ORRTreated patients (N = 94), independent central review | primarySource 2025 | 14% (8–23%) | — | Label Table 10: one complete response (1.1%) and 12 partial responses (13%); median duration of response 9.5 months (95% CI 4.4 to not estimable); duration of at least 6 months in 65% (95% CI 31-85) and at least 12 months in 41% (95% CI 11-69). The same 13 responders as the paper; the label rounds to whole percentages. |
| Endpoint | Analysis | Retifanlimab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled patients (n = 94) | primarymedian follow-up 7.1 monthsRao 2022 | 13.8% (7.6–22.5%) | — | One complete response (1.1%) and 12 partial responses (12.8%) by independent central review. Stable disease in 33 patients (35.1%) gave a disease control rate of 48.9% (95% CI 38.5-59.5). Responses were seen regardless of HIV or HPV status, PD-L1 expression or liver metastases. |
| DORResponders among 94 enrolled patients | primaryRao 2022 | median 9.5 months | — | The abstract gives a range of 5.6 months to not estimable rather than a confidence interval. |
| PFSAll enrolled patients (n = 94) | primaryRao 2022 | median 2.3 months (1.9–3.6) | — | — |
| OSAll enrolled patients (n = 94) | primaryRao 2022 | median 10.1 months | — | The 95% CI is 7.9 months to not estimable and cannot be stored. |
| ORRTreated patients (N = 94), independent central review | primarySource 2025 | 14% (8–23%) | — | Label Table 10: one complete response (1.1%) and 12 partial responses (13%); median duration of response 9.5 months (95% CI 4.4 to not estimable); duration of at least 6 months in 65% (95% CI 31-85) and at least 12 months in 41% (95% CI 11-69). The same 13 responders as the paper; the label rounds to whole percentages. |
- Retifanlimab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Retifanlimab |
|---|---|
| 0 | 100.0% |
| 6 | 64.5% |
| 12 | 41.7% |
| 18 | 26.9% |
| 24 | 17.4% |
- Retifanlimab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Retifanlimab |
|---|---|
| 0 | 100.0% |
| 1 | 74.0% |
| 3 | 40.5% |
| 4 | 30.0% |
| 6 | 16.4% |
Appears in
Sources
Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022;7(4):100529.
U.S. Food and Drug Administration. Prescribing information, Zynyz (retifanlimab-dlwr) injection, revised 5/2025, as approved with BLA 761334/S-004 (Reference ID 5591014).