Ferring Korea said Monday that it presented phase 3 clinical trial results of its fertility treatment, Rekovelle (follitropin delta), in Asian women at the European Society of Human Reproduction and Embryology (ESHRE) on June 28.
The GRAPE study compared conventional dosing of follitropin alfa with individual dosing of Rekovelle on Asian women, including Koreans. The trial was conducted on 1,009 women aged between 20 and 39 who had their first experiences of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).
The study's primary endpoint was to prove the non-inferiority of Rekovelle by observing the ongoing pregnancy rate for 10 to 11 weeks after the embryo transfer injected with both follitropin alfa and follitropin delta.
The result showed a similar ongoing pregnancy rate of Rekovelle (31.3 percent) and follitropin alfa (25.7 percent). For the secondary endpoint of the birthrate, Rekovelle also scored 31.3 percent, while follitropin alfa scored 24.7 percent. With a difference of 6.4 percent, Rekovelle showed a significantly higher rate. There were no cases of miscarriage or stillbirth in the Rekovelle group.
Besides, Rekovelle reduced the incidences of an ovarian hyper-stimulation syndrome (OHSS), proving its improved safety.
According to Ferring Korea, various biomarkers are being used to predict patients’ ovarian response, but insufficient or excessive responses are still prevalent. In ESTHER-1 analysis, Rekovelle showed a more optimal ovary production of eight to 14 than follitropin alfa. As a result, the percentage of cases of insufficient response (less than four eggs) or cases of excessive response (more than 15) was much less, too.
Through individualized dosing, Rekovelle also showed higher chances of attaining the targeted number of ovary production regardless of the patient’s anti-mullerian hormone (AMH).
"Rekovelle showed a higher birthrate with fewer doses than its competitors. Also, through individualized dosing, it had proven its safety and efficiency by not only minimizing the risks of OHSS and excessive response but also showing higher chances of an adequate number of ovary production,” said Professor Lee Jung Ryeol of the Department of Obstetrics and Gynecology at Seoul National University Bundang Hospital.
Based on extensive research of Asian women, including Koreans, its clinical significance and improved safety have been proven, he added.
The number of patients who received fertility treatment totaled about 230,000 last year, with 150,000 of them being women. The Ministry of Health and Welfare (MOHW) has subsidized costs for fertility treatment since 2017. In 2019, the support expanded to infertile patients of all ages.
Ferring Korea Managing Director Kim Beon-su said, “We are glad the effects of Rekovelle have been proved at ESHRE, an outstanding academy in the field of fertility treatment. The agency also showed a lot of interest in the research data performed on the Asian population and the trial experiences. Based on the data, we hope Rekovelle will be a new option to improve fertility treatment and birth rate.”