A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

Trial ID # NCT02799095; ARTISTRY-1
Phase I/II
Drug Class Immunotherapy: Immune Cell Stimulators/IL-2R
Drug Name Nemvaleukin alfa
Alternate Drug Names intermediate-affinity interleukin-2 receptor agonist ALKS 4230, Nemvaleukin, ALKS4230
Drugs in Trial Nemvaleukin alfa, Pembrolizumab
Eligible Participant

Advanced solid tumors

Patients Enrolled

16; median 5 prior therapies (2-6); 60% w/ prior Bev, 20% with prior checkpoint inhibitor therapy

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, evaluated per RECIST


Nem: 36 patients, median 3 prior therapies (1-8), 1 ovarian
27 evaluable: DCR: 51.9% (14SD)

Nem+Pem: 15 ovarian, median 5 prior therapies (2-6), 14 evaluable
ORR: 28.6% (2CR, 2PR; all responders BRCA WT, checkpoint inhibitor naive)
DCR: 71.4% (2CR, 2PR, 6SD - 1 SD on treatment for 18 months+)
DoR: 12.3 months


Nemvaleukin alfa (ALKS 4230) alone and with pembrolizumab is well tolerated with encouraging clinical benefit


Boni V et al. ARTISTRY-1: Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors. J Clin Oncol (2021) 39 (suppl 15; abstr 2513)

Boni V et al. Poster

Slide from SGO 2022 presentation; scientific plenary III, abstract 229

Vaishampayan UN et al. Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors: ARTISTRY-1. J Clin Oncol 40, 2022 (suppl 16; abstr 2500)

Vaishampayan UN et al. Slide from presentation

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