Mixed bag for Novartis and Astellas in breast cancer
pharmafile | December 15, 2014 | News story | Research and Development, Sales and Marketing | Afinitor, Astellas, Novartis, Xtandi, enzalutamide, everolimus
Preliminary results from a Phase II trial of Astellas’ Xtandi (enzalutamide) show positive benefits for the prostate cancer drug when used as a single therapy to treat women with advanced androgen-receptor positive, triple-negative breast cancer.
But Novartis’ bid to prove benefits for Afinitor (everolimus) as a first-line treatment for women with HER2-positive advanced breast cancer failed, after a Phase III trial found no benefit in this group of patients.
The data from both studies were presented at the San Antonio Breast Cancer Symposium in Texas. The trial involving Xtandi is the largest to date in patients with androgen-receptor positive triple-negative breast cancer, and the first to report objective responses to a hormonal therapy.
The study found that out of 26 women evaluated, 11 showed a clinically significant benefit after 16 weeks and 9 showed benefit after 24 weeks. More data is due in 2015 from a further 76 women enrolled in the study, but so far researchers have observed positive responses in one woman and partial positive responses in three more women in this group.
“The results suggest that Xtandi may provide a potential benefit to women with advanced androgen-receptor positive, triple-negative breast cancer,” says Dr Tiffany Traina, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York and lead researcher.
“This is encouraging for patients with this type of breast cancer because it is a particularly challenging subtype of the disease, for which the only available treatment option is chemotherapy.”
However, a Phase III study of Afinitor in combination with Herceptin (Roche) and paclitaxel showed no benefit as a first-line treatment in women with HER2+ locally advanced and metastatic breast cancer.
The results in 719 women showed there was no significant improvement in median progression-free survival with Afinitor (15.0 months) compared with women who took a placebo plus Herceptin and paclitaxel (14.5 months).
Xtandi is currently licensed for the treatment of advanced prostate cancer, while Afinitor is licensed for hormone receptor-positive advanced breast cancer in combination with exemestane. The trials were designed to gather evidence for applications for licence extensions in areas with unmet medical needs.
Currently there are no approved targeted therapies for women with triple-negative breast cancer, who are typically treated with multiple regimens of chemotherapy. Androgen-receptor positive triple-negative breast cancer is a recently-identified subtype that can express high levels of the androgen receptor.
Globally, an estimated 140,000 women are living with HER2+ advanced breast cancer, which represents approximately 20% of advanced breast cancer diagnoses.
Lilian Anekwe
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