Author: Dr. Alexis LeVee, City of Hope
At the ASCO 2024 conference, Dr. Alexis LeVee from City of Hope presented a pivotal Phase 1b clinical trial that explores the combination of CDK4/6 inhibitors and PD-1 inhibitors with endocrine therapy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2- mBC). This study investigates how these combinations can enhance anti-tumor responses and improve clinical outcomes.
Study Details:
- Objective: To evaluate the immunogenic effects of combining palbociclib (CDK4/6 inhibitor), pembrolizumab (PD-1 inhibitor), and endocrine therapy.
- Cohorts:
- Cohort 1: Patients already on palbociclib and endocrine therapy, adding pembrolizumab after stable disease for at least six months.
- Cohort 2: All three drugs administered from cycle one, day one, in first-line metastatic breast cancer.
- Cohort 3: Pembrolizumab given on day one, palbociclib as a lead-in on day minus one, with endocrine therapy to evaluate immune potentiation.
- Findings: Significant gut bacteria (Lachnospira, Fecalibacterium, Allostipes) were linked to better responses in patients undergoing the combination therapy.
Results:
- Adverse Events: Grade 3/4 neutropenia in 80% of patients, leukopenia in 50%, and liver toxicity in 15%. These were managed with dose adjustments and steroids.
- Survival Outcomes: Follow-up times varied, with survival outcomes for cohorts one and three not yet reached, and cohort two showing a progression-free survival (PFS) of 27 months.
Conclusion: The combination therapy shows promising results in enhancing immune response and improving clinical outcomes in HR+/HER2- mBC patients. Further evaluation in prospective trials is needed to confirm these findings.
Abstract: A phase I/II trial of palbociclib, pembrolizumab, and endocrine therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer (MBC): Clinical outcomes and stool microbial profiling https://meetings.asco.org/abstracts-presentations/233577
Related Content:
Outbound Links:
- City of Hope Comprehensive Cancer Center: Learn more about the innovative research and clinical trials being conducted at City of Hope, a leading cancer research and treatment center.
- American Society of Clinical Oncology (ASCO): Explore more presentations and studies from the ASCO 2024 conference, where leading oncologists and researchers share the latest advancements in cancer treatment.
- Breast Cancer Research Foundation (BCRF): For comprehensive information on breast cancer research, treatments, and patient resources, visit the Breast Cancer Research Foundation.