FLORENCE, Italy and HONG KONG, Nov. 8, 2023 /PRNewswire/ -- Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and SciClone Pharmaceuticals (Holdings) Ltd. ("SciClone"), an international biopharmaceutical company, announced today that they have signed an exclusive sublicense agreement to develop and commercialize ORSERDU® (elastrant) in the People's Republic of China (China), in an effort to expand treatment options for patients with metastatic breast cancer ( mBC) appropriate.
ORSERDU, a once-daily oral endocrine monotherapy, for the treatment of postmenopausal women or adult men with advanced or metastatic breast cancer with ER, HER2-, ESR1 mutations and disease progression after at least one line of endocrine therapy, It was approved by the United States Food and Drug Administration in January 2023 under its priority review and fast track designation. In September 2023, ORSERDU was approved by the European Commission. Stemline Therapeutics, a wholly owned subsidiary of Menarini Group, focused on providing transformational oncology treatments to cancer patients, markets ORSERDU in the United States and the EU.
Under the sublicense agreement, SciClone will continue the development and registration of ORSERDU in China and will commercialize ORSERDU upon regulatory approval in China.
"Patients living with metastatic breast cancer need effective and tolerable options," said Elcin Barker Ergun, CEO of Menarini Group. "We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can deliver efficacy in a once-daily pill."
Approximately 70% of breast cancer cases are ER, HER2-, and up to 40% of advanced ER, HER2- or mBC tumors harbor mutations in ESR1, which develop as a result of exposure to endocrine therapy in the metastatic environment. These mutations are a known factor of resistance to standard endocrine therapy and, until now, tumors harboring these mutations have been more difficult to treat.
"China accounts for 20% of the global breast cancer prevalence¹ and we know these patients need new therapeutic options, particularly in the metastatic setting," explained Zhao Hong, Executive Director, President and CEO of SciClone. "We believe this agreement will allow us to work to offer oncologists an important option in the treatment arsenal for their ER, HER2- mBC patients whose tumors have an ESR1 mutation."
The approval of ORSERDU in the United States and EU. is supported by data from the Phase 3 EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with elacestrant versus standard of care (SOC), defined as the investigator's choice of an approved endocrine monotherapy. The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months versus 1.9 months in SOC, and reduced the risk of progression or death by 45% (PFS HR=0 .55, 95% CI: 0.39, 0.77) versus SOC.
A post hoc subgroup analysis of EMERALD PFS results, presented at the San Antonio Breast Cancer Symposium (SABCS) 2022, demonstrated that duration of prior CDK4/6i treatment was positively associated with longer PFS with elacestrant, but not with SOC. For patients with ESR1 mutations who were treated with CDK4/6i for ≥12 months before randomization in EMERALD, elacestrant achieved a median PFS of 8.6 months versus 1.9 months in SOC, with a 59% reduction in the risk of progression or death (HR =0.41 95% CI: 0.26-0.63).²
Safety data were consistent with previously reported results. The most common adverse reactions with ORSERDU were musculoskeletal pain, nausea, increased triglycerides, increased cholesterol, vomiting, fatigue, dyspepsia, diarrhea, decreased calcium, back pain, increased creatinine, arthralgia, decreased sodium, constipation, pain headache, hot flashes, abdominal pain, anemia, decreased potassium and increased alanine aminotransferase. Important safety information for ORSERDU is provided below.
About the Phase 3 EMERALD Study (NCT03778931)
The Phase 3 EMERALD trial is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in patients with ER, HER2- advanced/metastatic breast cancer. The study included 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Study patients were randomly assigned to receive elacestrant or an approved hormonal agent, chosen by the investigator. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with mutations in the estrogen receptor 1 (ESR1) gene. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months versus 1.9 months in SOC, and reduced the risk of progression or death by 45% (PFS HR=0 .55, 95% CI: 0.39, 0.77) versus SOC.
About ORSERDU (elacestrant)
Indication in the United States: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men who are estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, ESR1 mutation advanced or metastatic. Breast cancer with disease progression after at least one line of endocrine therapy.
Complete prescribing information for the United States can be found at www.orserdu.com
Important Safety Information Warnings and Cautions
Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU with an incidence of 30% and 27%, respectively. The incidence of grade 3 and 4 hypercholesterolemia and hypertriglyceridemia was 0.9% and 2.2%, respectively. Monitor lipid profile before starting and periodically while taking ORSERDU.
Embryo-fetal toxicity: Based on findings in animals and its mechanism of action, ORSERDU may cause fetal harm when administered to a pregnant woman. Inform pregnant women and women of reproductive age about the potential risk to the fetus. Advise women of childbearing potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of childbearing potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose.
Adverse reactions
Serious adverse reactions occurred in 12% of patients receiving ORSERDU. Serious adverse reactions in >1% of patients receiving ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients receiving ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%) , decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flashes (11%) and dyspepsia (10%).
Interactions with other medications
Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in specific populations
Breastfeeding: Advise nursing women not to breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also being evaluated in early breast cancer disease.
About Menarini GroupMenarini Group is a leading international pharmaceutical and diagnostics company, with revenue of more than $4.4 billion and more than 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information, visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. ("Stemline"), a wholly owned subsidiary of Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapies. Stemline markets ORSERDU® (elacestrant) in the United States and the EU, an oral endocrine therapy indicated for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative postmenopausal women or adult men. , advanced or metastatic breast cancer with ESR1 mutation with disease progression after at least one line of endocrine therapy. Stemline also markets ELZONRIS® (tagraxofusp-erzs), a novel CD123-targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasia (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in United States and the EU to date. Stemline also markets NEXPOVIO® (selinexor), an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical portfolio of small molecules and biologics in various stages of development for a variety of solid and hematologic cancers.
About SciClone Pharmaceuticals (Holdings) Limited SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals", HKEX: 6600) is a global biopharmaceutical company with an integrated platform for the development and commercialization of innovative therapies for cancer and serious infections. With an innovation-driven strategic transformation, SciClone has established a product portfolio with differentiated advantages, including a number of potential first- and best-in-class products/pipelines. Staying true to the group's original aspiration of "SciClone gives life expectancy", SciClone is dedicated to improving the health of patients by providing world-class healthcare products and services with global standards of care. For more information about SciClone, visit www.sciclone.com.
1 Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Pineros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today, consulted on [01 Nov 2023].
² Bardia et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER /HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022. GS3-01
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