Yahoo Finance Radius (RDUS), Menarini Post Positive Data on Breast Cancer Drug
Radius Health, Inc. RDUS and partner The Menarini Group announced positive data from the phase III EMERALD study evaluating elacestrant as a monotherapy compared to standard of care (fulvestrant or aromatase inhibitor, AI) for the treatment of ER+/HER2- advanced or metastatic breast cancer.
The data were published in the Journal of Clinical Oncology.
Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced breast cancer.
The EMERALD study is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients.
Patients were randomized 1:1 to receive elacestrant (400 mg orally daily) or standard of care choice of fulvestrant or AI. Among the 477 patients enrolled in the trial, 239 received elacestrant.
The study met both its primary endpoints of progression-free survival (PFS) in the overall population and ESR1 mutated patients. Elacestrant significantly reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation. PFS rate at 12 months with elacestrant was 22.3% versus 9.4% with standard of care in the overall population and 26.8% versus 8.2% in the ESR1 mutation population.
Elacestrant demonstrated statistically significant PFS and reduced the risk of progression or death by 32% in the overall population and 50% in the ESR1 mutation population compared with fulvestrant.
Menarini will conduct combination studies and evaluate the potential of elacestrant in treating ER+/HER2-patients.
Shares of the company have lost 18% in the year so far compared with the industry’s decline of 25.9%.
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Earlier in the month, Radius reported a wider loss in the first quarter on lower revenues. However, the guidance for 2022 was reiterated. Lead drug Tymlos is most likely facing challenges.
Moreover, competition is stiff for Tymlos from Eli Lilly & Co's LLY Forteo and Amgen's AMGN Prolia.
Eli Lilly’s Forteo generated sales of $137 million in the first quarter.
Amgen’s Prolia sales increased 12% year over year in the first quarter, driven by 10% volume growth and higher net selling price. Amgen’s Evenity is also approved for treating osteoporosis in women after menopause who are at high risk of fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Radius currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the sector is Alkermes ALKS, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
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