(Solid Tumors) Is Nemvaleukin Alfa (ALKS 4320) Effective?
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- July 25, 2022
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From June 3–7, 2022, Ulka N. Vaishampayan et al. of University of Michigan Cancer Center presented at the American Society of Clinical Oncology meeting in Chicago, USA, the efficacy and safety results of nemvaleukin alfa (ALKS 4320) monotherapy and in combination with pembrolizumab (Keytruda) in solid tumor patients in the ARTISTRY-1 Phase 1/2 trial.
The ARTISTRY-1 trial was divided into three main groups: Group A — solid tumor patients using nemvaleukin alfa (ALKS 4320) monotherapy 10 µg/kg; Group B — malignant melanoma/renal cell carcinoma patients using nemvaleukin alfa (ALKS 4320); Group C — advanced solid cancer patients using nemvaleukin alfa (ALKS 4320) 3–6 µg/kg/day + pembrolizumab (21-day cycle). The primary endpoints were antitumor activity and safety.
Results from the 46 patients who participated in Group A: The recommended dose of nemvaleukin alfa (ALKS 4320) was determined to be 6 µg/kg/day, without reaching the maximum tolerated dose. Dose-limiting toxicity (DLT, Grade 4 adverse event: acute kidney injury) was confirmed in patients using nemvaleukin alfa (ALKS 4320) at 10 µg/kg.
Patients in Groups B and C had received at least 1–9 prior treatment regimens, including immune checkpoint inhibitors. The objective response rate for renal cell carcinoma patients receiving nemvaleukin alfa (ALKS 4320) monotherapy was 18.2% (N=4/22), and for malignant melanoma was 8.7% (N=4/46).
Grade 3–4 adverse events confirmed in Groups B and C included anemia (Group B 9% / Group C 10%) and neutropenia (Group B 34% / Group C 9%), consistent with the current confirmed safety profile.
Based on the ARTISTRY-1 trial results, Ulka N. Vaishampayan et al. stated: In solid tumor patients, nemvaleukin alfa (ALKS 4320) monotherapy and combination therapy confirmed durable antitumor effects in heavily pretreated patients, but further research is still needed.
Additionally, the U.S. FDA has designated nemvaleukin alfa (ALKS 4320) as a drug for treating melanoma and ovarian cancer, with melanoma designated as a rare disease.
Source: https://meetings.asco.org/abstracts-presentations/207280
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