Transformative breast cancer treatments underway: Five potential therapies set to revolutionize patient results
In the ongoing fight against breast cancer, several significant breakthroughs have been made in 2025. These advancements target hormone receptor-positive and PIK3CA-mutated breast cancer subtypes, with new therapy combinations promising improved survival and delayed chemotherapy.
Firstly, Celcuity's gedatolisib has shown promising results in a phase 3 trial for HR+, HER2- advanced breast cancer. The drug significantly reduces the risk of disease progression, and Celcuity plans to file for FDA approval later this year.
Similarly, Roche's Itovebi has received approval from the European Commission for PIK3CA-mutated, ER+ advanced breast cancer. This treatment has been shown to improve overall survival and delay the need for chemotherapy by approximately two years.
In early breast cancer, the UK’s NICE has expanded access to ribociclib (Kisqali) for hormone receptor-positive, HER2-negative patients at high risk of recurrence post-initial treatment. This represents a shift towards more aggressive adjuvant treatment to prevent disease return.
Breast cancer was once again the world's most studied disease for the fourth consecutive year in 2024. The incidence rate of breast cancer is rising by 1% per year overall, and 1.4% per year for women under the age of 50.
In the treatment landscape, BioNTech's acquisition of Biotheus for $800 million has given them control of bispecific antibody BNT327. This antibody combines PD-L1 checkpoint inhibition with the neutralization of VEGF-A and has the potential to unseat Merck's checkpoint inhibitor Keytruda in multiple cancer indications, including breast cancer. Positive results from a trial run by Biotheus in patients with locally advanced or metastatic triple-negative breast cancer who took BNT327 and nab-paclitaxel as a first-line therapy were reported in December 2024.
The drop in deaths from breast cancer over the past decade is linked to the wide array of new breast cancer treatments that have become available on the market. Relay Therapeutics' candidate for breast cancer treatment, RLY-2608, is a PI3Kα inhibitor designed to spare the normal enzyme in the hope of minimizing off-target effects and reducing toxicity. The phase 2 study of RLY-2608 demonstrated a median progression-free survival of 9.2 months in patients with heavily pre-treated PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
Oncolytics Biotech announced favorable results from a phase 2 trial assessing pelareorep, an immuno-oncolytic virus, in combination with chemotherapy drug paclitaxel in patients with HR+, HER2-negative metastatic breast cancer. The two-year survival rate for patients in the pelareorep and paclitaxel combination arm was 64% compared to 33% for paclitaxel monotherapy patients, and the overall response rate was 37.5% for the pelareorep and paclitaxel combination, compared to just 13.3% for paclitaxel on its own.
Big pharma companies are still working towards bringing even more new therapies to the market in an effort to broaden the treatment landscape further for breast cancer. The first-ever approval for an oral SERD for breast cancer came in 2023 when the FDA approved Menarini's Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
These advancements underscore the ongoing commitment to finding effective treatments for breast cancer, with a focus on improving patient outcomes and quality of life.
- New immunotherapy treatments are showing promising results in clinical trials for breast cancer, with Celcuity's gedatolisib and BioNTech's BNT327 demonstrating significant progress in hormone receptor-positive and PIK3CA-mutated subtypes respectively.
- In a shift towards aggressive adjuvant treatment, the UK’s NICE has expanded access to ribociclib for patients at high risk of breast cancer recurrence, suggesting a focus on early intervention for medical-conditions like breast cancer.
- The biopharma sector continues to make breakthroughs in the biotech industry, with companies like Relay Therapeutics and Oncolytics Biotech developing new pharmaceuticals for breast cancer treatment.
- The incidence rate of breast cancer, particularly among women under the age of 50, is rising, emphasizing the need for continued research and advancements in the health-and-wellness sector.
- The ongoing fight against breast cancer has witnessed several landmark approvals, such as Menarini's Orserdu, marking a step forward in the development of oral SERDs for this specific type of cancer.
