Very impressive results..... from the December 16th news
Data Highlights Include:
Of 9 patients treated, efficacy results include a disease control rate of 78% (7/9 patients) and an overall response rate of 67% (6/9 patients).
2 out of 9 patients to date have ongoing complete responses with durations ranging from 8 to 11 months, with a 3rd patient demonstrating a partial response (near complete response) in the target lesion after initiation of targeted and endocrine therapy off-study.
To date, 7 patients are alive with durations of response ranging from 2 to 12 months with 4 patients remaining on study. Median progression-free survival rate is 13.7 months.
All patients were treated in an outpatient setting with treatment generally safe and well tolerated and no observed cytokine release syndrome.
No immune related SAEs were attributed to the immunotherapy investigational agents
All patients had at least 1 grade ≥ 3 TRAE, primarily chemotherapy-related neutropenia or anemia. Grade ≥ 3 haNK-related AEs, namely fever and fatigue, were observed in 2 patients.
Early data from peripheral blood analysis demonstrate clonal selection occurs with the immunotherapy regimen enabling targeted therapy tailored to patient specific mutations identified via next generation sequencing.
"The approximately 10-20% of breast cancer patients who are triple negative are faced with a grim prognosis with limited treatment options. These results are clinically significant, with overall response rates and complete response rates in this highly refractory, advanced metastatic patient population," said Dr. Chaitali Nangia, a Hematologist/Oncologist with the Chan Soon-Shiong Immuno-Oncology Network and study co-author. "Importantly, these responses to treatment are also durable, with median progression free survival exceeding 13 months compared to historical controls of approximately 3 months in this heavily pretreated population. We also observed a positive safety and tolerability profile, with no cytokine release syndrome. Taken together, these efficacy and safety results point to the emergence of a new treatment paradigm for TNBC."
