Alkermes plc. (ALKS - Free Report) announced the initiation of the monotherapy expansion stage of its ARTISTRY-1 study to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma. The study will assess objective efficacy measures of ALKS 4230 administered intravenously daily for five consecutive days in up to 105 patients refractory to prior administered therapies with renal cell carcinoma or melanoma, two tumor types, for which high-dose IL-2 has demonstrated durable anti-tumor responses as a monotherapy treatment.
The first efficacy data from across the ALKS 4230 development program are expected to be presented at a medical meeting later in 2019, pending conference acceptance.
Shares of the company have declined 23.2% year to date against the industry’s growth of 2.3%.
Initiation of the monotherapy expansion portion of the ongoing study follows the identification of 6 µg/kg/day administered intravenously as the recommended monotherapy dose of ALKS 4230 to evaluate in these select tumor types. At the 6 µg/kg/day dose, data from the dose-escalation stage of ARTISTRY-1 demonstrated the desired tolerability profile for ALKS 4230 along with desired lymphocyte cell expansion without corresponding Treg activation.
The company selected the recommended phase II dose of ALKS 4230 as monotherapy after completing five dose-escalation cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day, in 36 patients who were refractory to prior administered therapies known to demonstrate clinical benefit.
We remind investors that ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase I/II study, in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. The study has three distinct stages — an ongoing monotherapy dose-escalation stage, the newly initiated monotherapy expansion stage and an ongoing combination therapy stage with Merck’s (MRK - Free Report) PD-1 inhibitor, Keytruda (pembrolizumab), in patients with select advanced solid tumors.
In February 2019, Alkermes initiated ARTISTRY-2, a phase I/II study of ALKS 4230 administered subcutaneously as monotherapy and in combination with Keytruda in patients with advanced solid tumors. ARTISTRY-2 will be conducted in two stages — the dose-escalation stage followed by the dose-expansion stage.
The company’s progress with pipeline candidates targeting major CNS disorders, such as schizophrenia, addiction, depression and multiple sclerosis, has been impressive.
Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. (ANIK - Free Report) and Applied Genetics Technologies Corp. (AGTC - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.
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