Radius Health, Inc. RDUS recently provided details on pipeline candidate elacestrant from the EMERALD study.
The phase III EMERALD study evaluated elacestrant as a monotherapy versus standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC). The trial enrolled patients who had received 1 or 2 prior lines of endocrine therapy (ET). Prior progression on an ET plus CDK4/6 inhibitors was mandated for all patients, and up to 1 line of chemotherapy was allowed.
Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group.
The trial met both primary endpoints demonstrating a statistically significant and clinically meaningful extension of progression-free survival (PFS) as monotherapy versus SoC ET in the overall population and estrogen receptor mutation (mESR1) population.
In the overall population, elacestrant reduced the risk of progression or death by 30% versus SoC. In the mESR1 population, elacestrant reduced the risk of progression or death by 45% versus SoC. PFS rate at 12 months with elacestrant was 22.32% versus 9.42% with SoC in the overall population and 26.76% versus 8.19% in the mESR1 population.
Elacestrant demonstrated statistically significant PFS and reduced the risk of progression or death by 32% in the overall population and 50% in the mESR1 population compared to Faslodex.
The results were presented at the San Antonio Breast Cancer Symposium (SABCS).
Radius and Menarini plan to proceed with regulatory submissions in the United States and European Union in 2022.
Concurrently, Radius Health announced top-line results from the phase III wearABLe study evaluating the non-inferiority (NI) of abaloparatide transdermal system (abalo-TDS) compared to abaloparatide subcutaneous injection in postmenopausal women with osteoporosis.
Abaloparatide injection is marketed as Tymlos in the United States for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as the history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
The wearABLe study did not meet its primary endpoint of NI for abalo-TDS 300 micrograms (ug) versus Tymlos 80 ug in the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at 12 months based on a NI margin of 2.0%.
Abalo-TDS group demonstrated an increase of 7.1% versus baseline, while Tymlos group demonstrated an increase of 10.9% versus baseline.
Shares of Radius were down 44.3% on these news. Investors were most likely disappointed and expected a better performance from elacestrant in the overall population. The disappointing results from the wearable study posed a setback as well.
Shares of the company have plunged 55.2% in the year so far compared with the industry’s decline of 17.6%.
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Tymlos’ revenues in the year so far have not matched management’s expectations. Concurrent with the third-quarter results, management lowered its guidance.
Competition is stiff for Tymlos in the targeted space from Amgen's AMGN Prolia, among others.
Amgen’s Prolia sales increased 15% year over year in the third quarter, driven by 13% volume growth.
Radius currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. SRPT and Viking Therapeutics VKTX, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Estimates for Viking Therapeutics have narrowed to a loss per share of $3.16 from $3.55 for 2021 and to $3.47 from $3.63 for 2022 in the past 30 days. VKTX delivered an earnings surprise of 2.06%, on average, in the last four quarters.
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