Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07220060, atirmociclib (PF-07220060), atirmociclib, Oral [14C]PF-07220060
PF-07220060 CDK4 inhibitor · 6 trials · 10 indications
iBCFS is defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria
iDFS defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, second primary invasive non-breast cancer, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
CCCA was determined by antigen Kiel 67 (Ki-67) value as decided by Sponsor. Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry. Assessment at Day 14 was done in blinded manner by centrally assessed biopsy.
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
First cycle (28 days) dose limiting toxicities
Adverse Events
safety laboratory abnormalities
vital signs and heart rate corrected QT interval
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
| Arm | Type | Description |
|---|---|---|
| Arm A : Atirmociclib + giredestrant | EXPERIMENTAL | Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day |
| Arm B: Placebo for atirmociclib + giredestrant | ACTIVE_COMPARATOR | Placebo atirmociclib tablets given orally twice a day plus giredestrant capsule given once a day |
| Arm A | EXPERIMENTAL | PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth |
| Arm B | ACTIVE_COMPARATOR | Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth |
| Arm A/Experimental/PF-07220060 plus letrozole | EXPERIMENTAL | PF-07220060 given as tablet by mouth twice a day for 14 days. Letrozole given as tablet by mouth once a day for 14 days. |
| Arm B/Control/letrozole | ACTIVE_COMPARATOR | Letrozole given by mouth once a day for 14 days. |
| Part 1 Dose Escalation - Dose Level 4 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 2A | EXPERIMENTAL | PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and Endocrine Therapy) |
| Part 1 Dose Escalation - Dose Level 3 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 2B | EXPERIMENTAL | PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior endocrine therapy and up to 1 prior line of chemotherapy for advanced or metastatic disease and no prior treatment with any CDK4/6 inhibitor for advanced disease) |
| Part 1 Dose Escalation - Dose Level 5 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 2C | EXPERIMENTAL | PF-07220060 + PF-07104091 + Letrozole (ER+/HER2- Breast Cancer with no prior treatment with any CDK4/6 inhibitor for advanced disease) |
| Part 1 Dose Escalation - Dose Level 2 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 1 Dose Escalation - Dose Level 1 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 1 Dose Escalation - Dose Level 6 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 1 Dose Escalation - Dose Level 7 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| Part 1 Dose Escalation - Dose Level 8 | EXPERIMENTAL | PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors) |
| 1A Monotherapy Escalation Arm 1 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1A Monotherapy Escalation Arm 2 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1A Monotherapy Escalation Arm 3 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1A Monotherapy Escalation Arm 4 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1A Monotherapy Escalation Arm 5 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1B Combination Dose Finding Arm 1 | EXPERIMENTAL | PF-07220060 with Letrozole combination Escalation |
| 1B Combination Dose Finding Arm 2 | EXPERIMENTAL | PF-07220060 with Letrozole Combination Escalation |
| 1C Combination Dose Finding Arm 1 | EXPERIMENTAL | PF-07220060 with Fulvestrant Combination Escalation |
| 1C Combination Dose Finding Arm 2 | EXPERIMENTAL | PF-07220060 with Fulvestrant Combination Escalation |
| 1D Monotherapy Food Effect | EXPERIMENTAL | PF-07220060 Monotherapy Food Effect |
| 1E DDI Cohort | OTHER | PF-07220060 DDI with Midazolam |
| 1F Combination Dose Finding | EXPERIMENTAL | PF-07220060 with Enzalutamide Escalation |
| 1G Combination Dose Finding Arm 1 | EXPERIMENTAL | PF-07220060 with Tamoxifen Combination De-Escalation |
| 2A Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with fulvestrant combination expansion |
| 2B Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with Letrozole Combination Expansion |
| 2C Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with fulvestrant Combination Expansion |
| 2E Combination Dose Expansion | EXPERIMENTAL | PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy |
| 2F Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with Tamoxifen Combination Expansion |
| Giredestrant Combination Cohort (Group A) | EXPERIMENTAL | PF-07220060 with Giredestrant Combination |
| Giredestrant Combination Cohort (Group B) | EXPERIMENTAL | PF-07220060 with Giredestrant Combination |
| Name | Type | Description |
|---|---|---|
| Atirmociclib | DRUG | Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day |
| giredestrant | DRUG | giredestrant capsule given once a day |
| Atirmociclib placebo | OTHER | Atirmociclib placebo tablet given twice a day |
| PF-07220060 | DRUG | CDK4 inhibitor |
| letrozole | DRUG | endocrine therapy |
| abemaciclib | DRUG | CDK4/6 inhibitor |
| palbociclib | DRUG | CDK4/6 inhibitor |
| ribociclib | DRUG | CDK4/6 inhibitor |
| PF-07220060 CDK4 inhibitor | DRUG | Experimental |
| Fulvestrant | DRUG | Experimental and Active comparator |
| Everolimus | DRUG | Active Comparator |
| Exemestane | DRUG | Active Comparator |
| PF-07220060 + PF-07104091 combination dose escalation | DRUG | PF-07104091 and PF-07220060 will be administered orally |
| PF-07104091 + PF-07220060 + fulvestrant dose expansion | DRUG | PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant |
| PF-07104091 + PF-07220060 + letrozole dose expansion | DRUG | PF-07104091 and PF-07220060 will be administered orally in combination with letrozole |
| Midazolam | OTHER | Benzodiazepine |
| Enzalutamide | COMBINATION_PRODUCT | Androgen Receptor inhibitor |
| Tamoxifen | COMBINATION_PRODUCT | Endocrine Therapy |
KEY INCLUSION CRITERIA 1. Histologically confirmed unilateral primary adenocarcinoma of the breast * ER-positive by local assessment * documented HER2-negative 2. Node positive or node negative as defined by: * Pathological node positive (microscopic and/or macroscopic tumor involvement ...
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PF-07220060 is being studied for advanced or metastatic breast cancer, early breast cancer, and liposarcoma. In breast cancer it is tested in hormone receptor positive, HER2-negative disease, including ER-positive early-stage settings, and is given in combinations such as letrozole, fulvestrant, or giredestrant.
PF-07220060 targets CDK4, a cyclin-dependent kinase involved in cell cycle progression. It is an oral small molecule designed to inhibit CDK4, and it is being developed as a targeted therapy for breast cancer and liposarcoma. It is also known as atirmociclib.
PF-07220060 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is running the clinical program for the drug, including combination studies with letrozole, fulvestrant, and giredestrant in breast cancer.
PF-07220060 is in Phase 2 development, and the program also includes Phase 3 trials. It is investigational and is not described as approved. The studies include a completed Phase 2 trial and active Phase 3 trials in breast cancer.
PF-07220060 trials include NCT07890597, a Phase 3 study with giredestrant in ER-positive, HER2-negative early breast cancer; NCT06760637, a Phase 3 study with letrozole in HR-positive, HER2-negative breast cancer; NCT06465368, a completed Phase 2 study with letrozole; and NCT06105632, a Phase 2 study with fulvestrant.
Yes, atirmociclib is another name for PF-07220060. The compound is also referred to as a CDK4 inhibitor, and some listings describe the PF-07220060 plus PF-07104091 combination dose escalation. All of these names refer to the same Pfizer-developed agent.