KEY TAKEAWAYS
- The ARTISTRY-7 phase III trial aims to evaluate the safety and efficacy of nemvaleukin in combination with pembrolizumab in platinum-resistant OC patients.
- The primary endpoint is PFS. Secondary/exploratory endpoints include OS, other antitumor measures, safety, health-related QoL, and PK/PD effects.
In the ARTISTRY-1 clinical trial, the combination of nemvaleukin alfa and pembrolizumab demonstrated encouraging antitumor activity in platinum-resistant ovarian cancer(OC) patients. About 4 patients experienced tumor responses, including two complete responses(CR) and two partial responses.
Researchers aim to evaluate the safety and efficacy of nemvaleukin in combination with pembrolizumab in platinum-resistant OC patients.
Eligible patients (≥18 years) with confirmed epithelial OC (high-grade serous, endometrioid, clear cell) and prior platinum-based therapy (≤5 lines of systemic anticancer therapy in platinum-resistant setting) will be enrolled.
Exclusions include primary platinum-refractory or primary platinum-resistant disease (progression on first-line platinum therapy or progression <3 months after first-line platinum therapy completion, respectively).
About 376 patients will be randomized (3:1:1:3) to receive nemvaleukin 6 μg/kg IV (days 1-5) + pembrolizumab 200 mg IV (day 1), pembrolizumab or nemvaleukin monotherapy, or chemotherapy. Stratification factors include PD-L1 status, histologic subtype, and chemotherapy (paclitaxel vs others).
Treatment continues until disease progression or intolerable toxicity (max 35 pembrolizumab cycles; nemvaleukin can be continued).
The primary endpoint is investigator-based progression-free survival(PFS) (RECIST v1.1) between nemvaleukin+pembrolizumab and chemotherapy. Secondary/extrapolatory endpoints include overall survival(OS), various antitumor measures, safety, health-related quality of life(QoL), and pharmacokinetic/pharmacodynamic(PK/PD) effects.
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trial: https://clinicaltrials.gov/study/NCT05092360
Sehouli J, Hays JL, Barlin JN, Buscema J, Cloven NG, Kong LR, Tyagi NK, Lanneau GS, Long BJ, Marsh RL, Seward SM, Starks DC, Welch S, Moore KN, Konstantinopoulos PA, Gilbert L, Monk BJ, O’Malley DM, Coleman RL, Herzog TJ; on behalf of the ARTISTRY-7 study investigators. ARTISTRY-7: A Phase 3, Multicenter Study Of Nemvaleukin Alfa In Combination With Pembrolizumab Versus Chemotherapy In Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (GOG-3063; ENGOT-OV68).
