Ipsen's Triptorelin + Tamoxifen Shows Benefits In Phase 3 Breast Cancer Trial
By C. Rajan, contributing writer
French pharmaceutical company, Ipsen, has announced that the use of its ovarian suppressant, triptorelin, as adjuvant treatment in combination with cancer drug tamoxifen was capable of reducing breast cancer recurrence in a Phase 3 trial. The results of the Phase 3 Suppression of Ovarian Function Trial (SOFT) clinical trial were presented by the International Breast Cancer Study Group (IBCSG) at the 2014 San Antonio Breast Cancer Symposium.
In the SOFT, monthly injections of triptorelin (active ingredient of Ipsen’s Decapeptyl) over five years resulted in complete ovarian suppression for 81 percent of patients. The randomized Phase 3 SOFT study was led by the IBCSG, and from 2003 to 2011, IBCSG enrolled more than 3,000 premenopausal women with hormone receptor-positive early-stage breast cancer and estradiol levels in the premenopausal range. The patients were treated for five years and continue to be followed for life to assess long-term prognosis and side effects.
The study showed that the combination of tamoxifen and ovarian suppression with triptorelin reduced the relative risk of developing invasive breast cancer recurrence by 22 percent in women who did not reach menopause post-chemotherapy, compared to tamoxifen treatment alone. The trial subjects were 40 years old on average when they began the hormonal therapy in the study.
Further analysis of the results showed that additional benefits could be obtained by treating these women with exemestane plus triptorelin, which reduced their relative risk of breast cancer recurrence by 35 percent, compared to tamoxifen alone. This translated to 7 or 8 fewer women out of 100 having their breast cancer recur within 5 years.
Claude Bertrand, EVP of R&D and CEO of Ipsen, said, “Ipsen is very pleased to have participated in this landmark study, which could change clinical practice in breast cancer treatment. In addition to solid efficacy results, the SOFT study provides the largest clinical trial safety database for the long term use of triptorelin in women.”
Triptorelin is a decapeptide analogue of the key hormone GnRH (Gonadotrophin Releasing Hormone), which is secreted by the hypothalamus and helps control the hormonal secretions by the testicules and ovaries. Triptorelin helps to suppress the activity of the GnRH and leads to menopause in women and hormonal castration in men.
Just two weeks ago, Ipsen also announced that its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxin A) in the treatment of upper limb spasticity in adult patients was accepted by the U.S. FDA for review.