Menarini and Sciclone Partner for ORSERDU in China to Address Advanced Breast Cancer

Menarini Group, a leading international pharmaceutical and diagnostics company, and SciClone Pharmaceuticals (Holdings) Ltd., an international biopharmaceutical company, have jointly declared an exclusive sub-licensing agreement. Their aim is to develop and commercialize ORSERDU® (elacestrant) in the People's Republic of China, with the goal of expanding treatment options for appropriate metastatic breast cancer (mBC) patients.

ORSERDU, a once-daily oral endocrine monotherapy, has been designed for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. This is specifically for cases where the disease has progressed following at least one line of endocrine therapy. It received approval from the U.S. Food and Drug Administration in January 2023 after a priority review and fast track designation. In September 2023, ORSERDU also gained approval from the European Commission. In the United States and the European Union, Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, is responsible for the commercialization of ORSERDU.

Under the sub-licensing agreement, SciClone will take on the responsibilities for developing and registering ORSERDU in China, as well as managing its commercialization upon regulatory approval in the country.

Menarini Group, emphasized the necessity for effective and well-tolerated treatment options for patients living with metastatic breast cancer. She expressed her pride in the partnership with SciClone to introduce a new breast cancer treatment in China that offers the convenience of a once-daily pill.

It's noteworthy that approximately 70% of breast cancer cases are ER+, HER2-, and up to 40% of ER+, HER2- advanced or mBC tumors carry ESR1 mutations. These mutations typically develop as a result of exposure to endocrine therapy in the metastatic setting and are known to drive resistance to standard endocrine therapy, making the treatment of such tumors particularly challenging.

SciClone, emphasized China's significant contribution to global breast cancer prevalence and stressed the importance of offering new therapeutic options, particularly for ER+, HER2- mBC patients with ESR1 mutations.

The approval of ORSERDU in the U.S. and the E.U. is based on data from the Phase 3 EMERALD trial, which demonstrated statistically significant improvements in progression-free survival (PFS) when compared to standard-of-care treatment. The study showed a median PFS of 3.8 months with elacestrant for patients with ESR1 mutations, compared to 1.9 months with standard-of-care, reducing the risk of progression or death by 45%. A post hoc analysis indicated that the duration of prior CDK4/6 inhibitor treatment was positively associated with longer PFS on elacestrant, particularly for patients with ESR1 mutations.

Safety data for ORSERDU remained consistent with previously reported results, with musculoskeletal pain, nausea, increased triglycerides, and increased cholesterol being among the common adverse reactions.

Elacestrant is currently under investigation in multiple clinical trials for metastatic breast cancer, either as a monotherapy or in combination with other therapies, including trials such as ELEVATE, ELECTRA, and ELCIN. Additionally, the drug is being evaluated for early breast cancer treatment.

The announcement also provided important safety information and guidelines for the use of ORSERDU, highlighting potential adverse reactions and drug interactions, among other considerations.

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