Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease.
The race to develop an oral selective estrogen receptor degrader (SERD) is under fresh scrutiny in light of Sanofi SA’s decision to axe development of its late-stage compound amcenestrant on Aug. 17, citing lack of efficacy in breast cancer trials. While there are concerns about the new class after Sanofi’s decision, a clear signal about its future could be growing nearer. The driver? Menarini Group and its development partner, Radius Health Inc., are advancing elacestrant, an oral SERD into regulatory reviews on both sides of the Atlantic.
Armed with compelling phase IIb data and with two phase III trials underway, Newamsterdam Pharma BV has sealed a European commercialization deal worth more than €1 billion (US$1.6 billion) with Menarini Group for its cholesterol lowering drug, obicetrapib.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
The business of cancer therapy in the U.S. is where the big money is, and the Menarini Group, a privately held Italian pharma and diagnostics company, just got a place at the table with its acquisition deal worth up to $677 million for New York’s Stemline Therapeutics Inc.