Background
Metastatic Triple Negative Breast Cancer, mTNBC, has limited treatment options for patients and thus represents a highly unmet need.
In this phase Ⅱ trial, the investigators evaluated the combination of the anti–PD-1, Camrelizumab, the tyrosine kinase inhibitor, Famitinib, and Gemzar.
This combination was given to a subtype of Triple Negative Breast Cancer, TNBC, patients who were found to have “immunomodulatory Triple Negative Breast Cancer”.
What is “Immunomodulatory Triple Negative Breast Cancer”?
This is when cancer cells are identified as CD8-positive cells by a test called “Immunohistochemistry, IHC”.
About the Study
The researchers assessed the combination in 48 patients with unresectable locally advanced or metastatic TNBC, who had not received prior treatment. This was their First line treatment.
All patients must have had immunomodulatory greater than or equal to 10% in the IHC test.
Camrelizumab, a monoclonal antibody against PD-1, plus Gemzar exhibited promising antitumor activity in refractory metastatic immunomodulatory TNBC.
Famitinib is a tyrosine kinase inhibitor targeting VEGFR2, PDGFR and c-kit.
Eligible patients received 20 mg of oral Famitinib on days 1-28, 200 mg of intravenous Camrelizumab on days 1 and 15, and intravenous Gemzar 100 mg/m2 on days 1, 8 and 15 in 4-week cycles.
Results for Triple Negative Breast Cancer Patients
- Forty-eight patients were enrolled and treated.
- 3% of patients achieved either control of their disease, the tumors did not continue to grow, or their tumors shrunk.
- 5 patients achieved complete remission!
- Median time until the disease progressed again was 13.6 months
- Median duration of response among those who responded to the combination was 14.9 months
- Median Survival was not reached at the time of the analysis of the study data
- PD-L1-positive patients had favorable response
- PKD1 and KAT6A somatic mutations were associated with therapy response
- No treatment-related deaths were reported
Conclusions
The triplet regimen was efficacious and well tolerated in previously untreated, advanced, immunomodulatory TNBC.
The randomized controlled FUTURE-SUPER trial is underway to validate these findings.
Take-Home Message for Triple Negative Breast Cancer Patients
This study demonstrated that this triplet combination is well tolerated and highly effective as first-line therapy for patients with metastatic TNBC.
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