News & Trends - Pharmaceuticals
BMS immunotherapy doubles cure rates in early stage ER+/HER2− breast cancer

In a new development for early-stage, high-risk breast cancer treatment, the addition of BMS’ immunotherapy drug to neoadjuvant chemotherapy has shown significant results in enhancing cure rates.
The Phase III CheckMate-7FL trial involved 510 people with early stage, high risk oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer which accounts for around 70% of all breast cancers. These patients receive chemotherapy to shrink their tumour prior to surgery.
This Peter MacCallum Cancer Centre-led international clinical trial assessed the impact of adding BMS’ Opdivo (nivolumab), an immune checkpoint inhibitor, versus a placebo during the pre-surgery phase. The results, now published, mark a significant shift in treatment strategies.
Professor Sherene Loi, a medical oncologist at Peter Mac who led the trial, said adding nivolumab led to around a doubling in the number of patients who achieved the best possible outcome known as a pathological complete response (pCR).
“These patients are considered to be likely cured because their tumour was removed and samples of breast and lymph node tissue collected at the same time also show no detectable cancer cells,” explained Professor Loi.
“The number of patients who achieved this pCR improved significantly as a result of nivolumab, an exciting result that points to a new treatment paradigm in this most common type of breast cancer.”
Overall, the trial reported pCR rates of 25% in Opdivo-treated participants compared to 14% in the placebo group (P = 0.0021). Among patients with tumours expressing the PD-L1 biomarker – indicating heightened response to Opdivo – the pCR rate soared to 44% versus 20% in the placebo group.
Professor Loi cautioned that while outcomes for these patients generally show promise, variations exist, particularly in more aggressive forms of ER+/HER2- breast cancer, especially in younger women prone to recurrence.
“It seems that these may be the most responsive to immunotherapy and chemotherapy,” she noted.
The study’s authors highlighted these findings as “a new milestone in the neoadjuvant treatment of ER+/HER2− BC, because there have been intensive but thus far unsuccessful efforts to improve pCR rates in this patient population.”
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