Britain has approved Ipsen Pharmaceuticals’ Decapeptyl (triptorelin) in combination with tamoxifen or an aromatase inhibitor to treat pre-menopausal, early stage breast cancer patients.
The approval came from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). It covers Decapeptyl’s use as an adjuvant therapy — that is, one that improves the effectiveness of other treatments.
Fourteen other European regulatory agencies have also approved Decapeptyl’s use for early stage breast cancer. The decisions were based on the results of two international clinical trials that assessed Decapeptyl in 5,700 patients across 27 countries. The trials were supported by the International Breast Cancer Study Group (IBCSG).
The Phase 3 trials, SOFT (NCT00066690) and TEXT (NCT00066703), evaluated the value of adding Decapeptyl, an ovarian function suppressor, to adjuvant tamoxifen or the aromatase inhibitor Aromasin (exemestane) in pre-menopausal women, compared with the use of tamoxifen alone.
Decapeptyl contains the active ingredient triptorelin, a type of medicine known as a gonadorelin analogue. It acts on the pituitary gland in the brain.
Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression, combined with hormone therapy using tamoxifen or Aromasin, may fight breast cancer by reducing the production of estrogen.
The women in the clinical trials had early stage hormone receptor-positive breast cancer and were at high risk of the cancer recurring. They were confirmed as pre-menopausal after completing their chemotherapy.
The primary goal of the studies was for women who took Decapeptyl plus tamoxifen to have longer disease-free survival than those who took Decapeptyl plus Aromasin. The SOFT study also compared the disease-free survival rates of women who took a combination of Decapeptyl and tamoxifen with women who took tamoxifen alone.
Combining Decapeptyl with tamoxifen failed to improve patients’ disease-free survival, compared with tamoxifen alone. But women who took Decapeptyl and Aromasin were at 32 percent less risk of developing a health problem that threatened their disease-free survival than women who took tamoxifen alone. And women on the Decapeptyl-Aromasin combination were at 28 percent less risk than women on Decapeptyl and tamoxifen.
The Decapeptyl-Aromasin combination also led to a 36 percent reduction in the risk of breast cancer recurrence, compared with tamoxifen alone, and a 34 percent reduction compared with Decapeptyl and tamoxifen.
Based on the results, St Gallen, the National Comprehensive Cancer Network (NCCN), the European Society for Medical Oncology (ESMO), and the American Society of Clinical Oncology (ASCO) updated their early stage breast cancer treatment guidelines. The new guidelines include a recommendation that an ovarian function suppressor be used in combination with tamoxifen or Aromasin to treat these patients.
The clinical trial findings were presented at two conferences in 2014: the annual meeting of the American Society of Clinical Oncology in Chicago and the San Antonio Breast Cancer Symposium. The New England Journal of Medicine also published the results.
“We are pleased to receive the first European approval which brings a new treatment option offering disease free survival benefit for high-risk pre-menopausal breast cancer patients,” Alexandre Lebeaut, executive vice president of research and development and chief scientific officer at Ipsen, said in a press release.
“This is the result of a longstanding scientific collaboration between Ipsen and the IBCSG, one of the leading international cooperative groups in Breast Cancer which exemplifies Ipsen’s continuous commitment to improving patients care,” he said.
“IBCSG initiated those 2 prospective studies SOFT and TEXT more than fifteen years ago with the ambitious goal to address a major question on the role of OFS in the adjuvant setting for premenopausal women,” said Meredith M. Regan, an associate professor of Medicine at Harvard Medical School.
“We are very happy that these studies have been the foundation for a MHRA approval of triptorelin which will facilitate patient’s access to this new treatment paradigm. We thank Ipsen for their support since the beginning of those studies,” added Regan, who is also an associate professor in the Department of Biostatistics and Computational Biology at the Dana-Farber Cancer Institute.