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"At the 6 µg/kg/day dose, data from the dose-escalation stage of ARTISTRY-1 demonstrated the tolerability profile we set out to achieve for ALKS 4230, along with desired lymphocyte cell expansion without corresponding Treg activation. This validates our design rationale for ALKS 4230, and we now look forward to progressing into the expansion stage to evaluate ALKS 4230 as monotherapy in select tumor types," said
Selection of the recommended phase 2 dose of ALKS 4230 as monotherapy was made following the completion of 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. Data from the completed cohorts demonstrated dose-dependent pharmacodynamic effects on circulating natural killer (NK) cells and CD8+ T cells, and minimal and non-dose dependent effects on immunosuppressive regulatory T cells (Tregs). The newly initiated monotherapy expansion stage 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.1
Data from the initial four cohorts of the dose-escalation stage of ARTISTRY-1 were presented at the 2018
About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.
About the ARTISTRY Clinical Program
ARTISTRY is an
ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of ALKS 4230; clinical development plans for ALKS 4230, including details of the ongoing ARTISTRY-1 and ARTISTRY-2 phase 1/2 studies and the company's plans for presentation of data relating to the ARTISTRY development program. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include, among others, whether preclinical and early clinical results for ALKS 4230, as a monotherapy or in combination with pembrolizumab, will be predictive of future clinical study results; whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of development activities for ALKS 4230; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended
KEYTRUDA® is a registered trademark of
1 Rosenberg S. A. (2014). IL-2: the first effective immunotherapy for human cancer. Journal of immunology (
For Media: Gretchen Murphy, +1 781 609 6419
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