Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07220060 CDK4 inhibitor, atirmociclib (PF-07220060), atirmociclib, Oral [14C]PF-07220060
PF-07220060 · 5 trials · 7 indications
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.
First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
Adverse Events
safety laboratory abnormalities
vital signs and heart rate corrected QT interval
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
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
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 2B Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with Letrozole Combination Expansion |
| 2C Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with fulvestrant Combination Expansion |
| 1D Monotherapy Food Effect | EXPERIMENTAL | PF-07220060 Monotherapy Food Effect |
| 1A Monotherapy Escalation Arm 5 | EXPERIMENTAL | PF-07220060 Monotherapy Escalation |
| 1F Combination Dose Finding | EXPERIMENTAL | PF-07220060 with Enzalutamide Escalation |
| 1E DDI Cohort | EXPERIMENTAL | PF-07220060 DDI with Midazolam |
| 2D Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with enzalutamide Combination Expansion |
| 2A Combination Dose Expansion | EXPERIMENTAL | PF-07220060 with fulvestrant combination dose expansion |
| 2E Combination Dose Expansion | EXPERIMENTAL | PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy |
| 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) |
| Name | Type | Description |
|---|---|---|
| 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 |
| Midazolam | DRUG | Benzodiazepine used for DDI |
| Enzalutamide | COMBINATION_PRODUCT | Androgen Receptor inhibitor |
| 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 |
Inclusion Criteria: * Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor * Doc...
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PF-07220060, also known as atirmociclib, is an investigational oral small molecule developed by Pfizer for advanced or metastatic breast cancer. It is a CDK4 inhibitor and is also being studied in healthy volunteers and in people with hepatic impairment. It is currently in Phase 2 development and has not been approved by the FDA.
PF-07220060 is being studied for the treatment of advanced or metastatic breast cancer. Development is biomarker selected, meaning patients are chosen based on a specific biomarker. It remains investigational and is in Phase 2 clinical development, so it is not yet available as an approved therapy for breast cancer.
PF-07220060 targets CDK4, a cyclin-dependent kinase involved in cell cycle progression. By inhibiting CDK4, the drug is designed to interfere with the signaling that drives tumor cell division. This CDK4 inhibition is the basis for its study in advanced or metastatic breast cancer.
PF-07220060 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is running the clinical program for atirmociclib, including the Phase 2 breast cancer studies and the Phase 1 studies in healthy volunteers and hepatic impairment.
PF-07220060 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes Phase 2 studies in advanced or metastatic breast cancer along with Phase 1 studies in healthy participants and people with hepatic impairment.
PF-07220060 has been studied in trials including NCT07677358, a recruiting Phase 1 study of atirmociclib in people with normal liver function and different levels of liver disease, and NCT07215078, a completed Phase 1 study of dose-proportional exposure in healthy participants. Other completed Phase 1 trials include NCT07160738 and NCT07130097.
Yes, atirmociclib is the alternative name for PF-07220060. The two names refer to the same Pfizer CDK4 inhibitor. Related search terms include PF-07220060 CDK4 inhibitor and the PF-07220060 plus PF-07104091 combination dose escalation, which refers to study of PF-07220060 in combination with another agent.