A new triple therapy has shown promise for women with advanced breast cancer. The treatment combines two targeted drugs, inavolisib and palbociclib, with the hormone therapy fulvestrant. Researchers reported that patients on the triple therapy lived an average of seven months longer than those who received palbociclib and fulvestrant alone. The triple therapy also delayed disease progression to 17.2 months, compared with 7.3 months in the control group. Moreover, patients on inavolisib were able to postpone further chemotherapy by nearly two years.
Major Study Presented at ASCO Annual Meeting
The findings come from an international trial funded by Roche. Results were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and published in the New England Journal of Medicine. The trial enrolled 325 patients from 28 countries, including the United States, United Kingdom, Australia, Singapore, Brazil, France, and Germany.
Focus on HR+, HER2- Breast Cancer with PIK3CA Mutations
Hormone receptor–positive (HR+), HER2-negative breast cancer affects about 70% of patients. Within this group, roughly 35% to 40% carry PIK3CA mutations. These mutations are linked to increased tumor growth, faster disease progression, and resistance to treatment. The trial specifically targeted women with untreated metastatic breast cancer that carried a PIK3CA mutation.
Significant Tumor Reduction and Improved Outcomes
The study showed that 62.7% of patients on the triple therapy experienced a significant reduction in cancer cell growth. This compares with just 28% in the control group. Dr. Simon Vincent, Director of Research, Support, and Impact at Breast Cancer Now, called the results a “major breakthrough.”
Dr. Nisharnthi Duggan, Research Information Manager at Cancer Research UK, added, “The trial showed that adding inavolisib to a targeted treatment regimen can improve survival. It also slows cancer progression and reduces the need for chemotherapy. This can improve quality of life and allow patients to spend more time with their loved ones.”
Trial Design and Patient Population
More than half of the patients in the trial had cancer that had spread to at least three organs. All participants underwent a liquid biopsy (circulating tumor DNA) to confirm the presence of a PIK3CA mutation. Patients were then randomly assigned to receive either the inavolisib-based regimen or the control regimen of palbociclib, fulvestrant, and a placebo.
Inavolisib works by blocking PIK3CA protein activity. Most patients tolerated the combination well, with only a few discontinuing treatment due to side effects.
Expert Commentary on Impact and Next Steps
Dr. Jane Lowe Meisel, Co-Director of Breast Medical Oncology at the Winship Cancer Institute of Emory University, said, “The INAVO120 trial identified a targeted treatment option that can significantly improve survival in patients with PIK3CA-mutated HR+ metastatic breast cancer. This is a major step forward.”
Professor Nick Turner, of the Institute of Cancer Research, London, and Consultant Medical Oncologist at the Royal Marsden NHS Foundation Trust, led the UK arm of the study. “Inavolisib-based therapy not only helped patients live longer, but it more than doubled the time to disease progression. It also delayed the need for follow-up chemotherapy, which we know patients fear and want to avoid for as long as possible,” he said.
A New Standard for Targeted Therapy?
Experts believe these results demonstrate the potential of triple therapy for women who carry PIK3CA mutations. By combining two targeted drugs with hormone therapy, this regimen offers a more personalized approach. Patients can expect longer survival, slower tumor growth, and a reduced need for aggressive chemotherapy.
Further research is underway to confirm these findings and explore other patient populations. However, the INAVO120 trial marks a promising advance in treating HR+, HER2- breast cancer.
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