Although the pembrolizumab 8 arm of I-SPY2 did not have strong enough results to continue onto phase 3, it does provide some insights and highlights the need for precision medicine to tailor approaches to treatment, said Rita Nanda, MD, associate professor, medicine, The University of Chicago Medicine.
Although the pembrolizumab 8 arm of I-SPY2 did not have strong enough results to continue onto phase 3, it does provide some insights and highlights the need for precision medicine to tailor approaches to treatment, said Rita Nanda, MD, associate professor, medicine, The University of Chicago Medicine.
Transcript
Based off the results from I-SPY2 phase 2 trial, Pembro8-noAC did not appear to perform well enough to warrant a phase 3 trial. What are the next steps in treatment development for patients with early stage, high-risk HER2 negative breast cancer?
So, as you know that pembrolizumab 8 arm of I-SPY2, which removed the AC [doxorubicin and cyclophosphamide] from the last 4 cycles of therapy did not graduate. The pembrolizumab 8 arm appeared to be as effective as Taxol followed by AC, and therefore, didn't graduate, and we won't be pursuing it further.
There are, however, likely a subset of patients who don't need anthracycline-based chemotherapy. I personally had some patients who did very well on that arm of the trial. So, I think what we really need to look at in terms of the data from that trial is the biomarker work, because I think what we're hoping to move to to the future is precision medicine where we can really tailor our approaches to what any individual patient needs.
I think a lot of patients don't need as much chemotherapy as we're currently giving and may be able to de-escalate chemotherapy. I think that some patients need chemotherapy and maybe won't benefit from immune-based strategies. I think looking at the biomarker work that's going to come from I spy two will be really helpful in moving forward, how we want to plan the next generation of trials for women with early-stage HER2-negative breast cancer.
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