Trial results for the ARTISTRY-7 study (NCT05092360) evaluating nemvaleukin alfa in combination with pembrolizumab for platinum-resistant epithelial ovarian cancer were posted on ClinicalTrials.gov on 2025-08-28. The Phase 3 study was terminated, with key outcome measures showing no superior overall survival or objective response rates for the combination compared to investigator's choice chemotherapy.
Background
The ARTISTRY-7 study investigated pembrolizumab (Keytruda) in combination with nemvaleukin alfa for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Trial design
The ARTISTRY-7 study (NCT05092360) was a Phase 3, multicenter, open-label, randomized trial that enrolled 456 participants. The study focused on patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants were randomized to receive either nemvaleukin 6 mcg/kg and pembrolizumab 200 mg, pembrolizumab 200 mg, nemvaleukin 6 mcg/kg, or Investigator's Choice Chemotherapy (including pegylated liposomal doxorubicin (pld) or paclitaxel).
Key results
The trial results for Overall Survival (OS) showed similar median values across the treatment arms:
- The median OS for the nemvaleukin 6 mcg/kg and pembrolizumab 200 mg combination arm was 10.1 months.
- The median OS for the pembrolizumab 200 mg monotherapy arm was also 10.1 months.
- Patients receiving nemvaleukin 6 mcg/kg monotherapy had a median OS of 10.7 months.
- The Investigator's Choice Chemotherapy arm showed a median OS of 9.8 months.
For Objective Response Rate (ORR) as assessed by the investigator:
- The nemvaleukin 6 mcg/kg and pembrolizumab 200 mg combination arm had an ORR of 9.2 percentage of participants.
- The pembrolizumab 200 mg monotherapy arm had an ORR of 0.0 percentage of participants.
- The nemvaleukin 6 mcg/kg monotherapy arm also had an ORR of 0.0 percentage of participants.
- The Investigator's Choice Chemotherapy arm achieved an ORR of 11.1 percentage of participants.
Regarding Disease Control Rate (DCR) as assessed by the investigator:
- The nemvaleukin 6 mcg/kg and pembrolizumab 200 mg combination arm had a DCR of 34.2 percentage of participants.
- The pembrolizumab 200 mg monotherapy arm had a DCR of 25.9 percentage of participants.
- The nemvaleukin 6 mcg/kg monotherapy arm had a DCR of 36.4 percentage of participants.
- The Investigator's Choice Chemotherapy arm showed the highest DCR at 52.1 percentage of participants.
What this means
The termination of the ARTISTRY-7 trial, coupled with the reported outcomes, suggests that the combination of nemvaleukin alfa and pembrolizumab, as well as pembrolizumab monotherapy, did not demonstrate a significant clinical benefit over standard Investigator's Choice Chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The similar overall survival figures and lower objective response and disease control rates for the investigational arms compared to chemotherapy indicate a lack of superiority in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05092360, titled 'Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7),' were posted on 2025-08-28 on clinicaltrials.gov.