Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SSGJ-707
PF-08634404 · 11 trials · 60 indications
PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.
pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens
Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator.
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
DLTs are a predefined set of adverse events that are at least possibly related to any or all of the study interventions. The number of participants who experienced DLTs during the DLT observation period.
ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.
The doses of PF-08634404 and ipilimumab selected to be used in combination based on safety, tolerability, pharmacokinetics, and initial anti-tumor efficacy from Phase 2.
| Arm | Type | Description |
|---|---|---|
| PF-08634404 plus Chemotherapy | EXPERIMENTAL | PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy |
| Pembrolizumab plus Chemotherapy | ACTIVE_COMPARATOR | Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy |
| Arm A | EXPERIMENTAL | Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404. |
| Arm B | ACTIVE_COMPARATOR | Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab. |
| Arm C | EXPERIMENTAL | Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy. |
| Arm D | ACTIVE_COMPARATOR | Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy. |
| PF-08634404 + Chemotherapy | EXPERIMENTAL | Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy. |
| Bevacizumab + Chemotherapy | ACTIVE_COMPARATOR | Participants will receive bevacizumab IV in combination with Chemotherapy. |
| PF-08634404 | EXPERIMENTAL | Participants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404. |
| Part A: Neoadjuvant PF-08634404 + Chemotherapy | EXPERIMENTAL | Participants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy. |
| Part B: Adjuvant PF-08634404 Monotherapy | EXPERIMENTAL | Participants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV. |
| Part C: PF-08634404 Monotherapy Consolidation after Definitive Chemoradiotherapy | EXPERIMENTAL | Participants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV. |
| Phase 2 Portion | EXPERIMENTAL | PF-08634404 + Chemotherapy |
| Phase 3: Arm A | EXPERIMENTAL | PF-08634404 + Chemotherapy |
| Phase 3: Arm B | ACTIVE_COMPARATOR | Nivolumab + Chemotherapy |
| Phase 2 Single arm | EXPERIMENTAL | Participants will receive PF-08634404 in combination with chemotherapy |
| Phase 3 Experimental Arm | EXPERIMENTAL | Participants will receive PF-08634404 in combination with chemotherapy |
| Phase3 Control Arm | ACTIVE_COMPARATOR | Participants will receive atezolizumab in combination with chemotherapy |
| Cohort A | EXPERIMENTAL | Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
| Cohort B | EXPERIMENTAL | Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
| Cohort C | EXPERIMENTAL | Participants will receive PF-08634404 IV in combination with axitinib. |
| Cohort D | EXPERIMENTAL | Participants will receive PF-08634404 in combination with Casdatifan. |
| PF-08634404 + PF-08046054/SGN-PDL1V (Part B) | EXPERIMENTAL | Participants will receive PF-08634404 in combination with other anticancer agents as per protocol. |
| PF-08634404 + Sigvotatug Vedotin (Part A) | EXPERIMENTAL | Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. |
| Phase 1b | EXPERIMENTAL | Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab. |
| Phase 2 | EXPERIMENTAL | Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab. |
| Name | Type | Description |
|---|---|---|
| PF-08634404 | BIOLOGICAL | Solution for IV infusion |
| Pembrolizumab | BIOLOGICAL | Solution for IV infusion |
| Standard of Care Chemotherapy | DRUG | Solution for IV infusion |
| Chemotherapy Regimen 1 | DRUG | Injection for IV use |
| Chemotherapy Regimen 2 | DRUG | Injection for IV use |
| Bevacizumab | BIOLOGICAL | Injection for intravenous use |
| Chemotherapy | DRUG | Injection for intravenous use |
| Nivolumab | BIOLOGICAL | Participants will receive Nivolumab intravenously. |
| Atezolizumab | BIOLOGICAL | Injection for intravenous use |
| Enfortumab Vedotin | BIOLOGICAL | Powder for concentrate for solution for infusion |
| Ipilimumab | DRUG | Solution for infusion |
| Axitinib | DRUG | Tablet |
| Casdatifan | DRUG | Tablet |
| Sigvotatug Vedotin | BIOLOGICAL | -Powder for concentrate for solution for infusion. Single use vial |
| PF-08046054/SGN-PDL1V | BIOLOGICAL | -Powder for concentrate for solution for infusion. Single use vial. |
Inclusion Criteria: * Women ≥18 years of age who are confirmed not pregnant at screening. * Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded. * Newly diagnosed FIGO Stage III disease with measurab...
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PF-08634404 is an investigational monoclonal antibody being developed by Pfizer for the treatment of several cancer types. It is in Phase 3 clinical development for advanced or recurrent MMR-proficient endometrial cancer and is also being studied in non-small cell lung cancer and other solid tumors. It has not been approved by the FDA.
PF-08634404 targets PD-1, a protein on immune cells that normally restrains immune responses. By binding PD-1, the antibody is designed to block this checkpoint and allow the immune system to attack tumor cells. PD-1 is a well-established immune checkpoint target in oncology.
PF-08634404 is being studied for advanced or recurrent MMR-proficient endometrial cancer, early-stage or locally advanced non-small cell lung cancer, transformed small cell lung cancer, and urothelial cancer. It is an investigational therapy and is not approved for any indication. Trials are evaluating it both alone and in combination with chemotherapy or enfortumab vedotin.
Pfizer, Inc. (ticker: PFE) is developing PF-08634404. The company is running the clinical program, which includes studies in endometrial cancer, non-small cell lung cancer, transformed small cell lung cancer, and urothelial cancer. Pfizer is the sole developer named for this asset.
PF-08634404 is in Phase 3 development, with a Phase 3 trial in advanced or recurrent MMR-proficient endometrial cancer that has not yet begun recruiting. Additional Phase 2 and Phase 1 studies are ongoing. The drug is investigational and has not received FDA approval.
PF-08634404 is being evaluated in four registered trials. These include NCT07578649 (Phase 3, endometrial cancer), NCT07489066 (Phase 2, non-small cell lung cancer), NCT07476287 (Phase 2, transformed small cell lung cancer), and NCT07421700 (Phase 1, urothelial cancer). Total planned enrollment across these studies is approximately 892 participants.