Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma

鈥� An ASCO Reading Room selection

November 18, 2021

Adi Diab, MD; Scott S. Tykodi, MD, PhD; Gregory A. Daniels, MD, PhD; Michele Maio, MD; Brendan D. Curti, MD; Karl D. Lewis, MD; Sekwon Jang, MD; Ewa Kalinka, MD, PhD; Igor Puzanov, MD, MSc; Alexander I. Spira, MD, PhD; Daniel C. Cho, MD; Shanhong Guan, PhD; Erika Puente, MD; Tuan Nguyen, PhD; Ute Hoch, PhD; Sue L. Currie, PhD; Wei Lin, MD; Mary A. Tagliaferri, MD; Jonathan Zalevsky, PhD; Mario Sznol, MD; and Michael E. Hurwitz , MD, PhD

Journal of Clinical Oncology

This Reading Room is a collaboration between 口袋女优庐 and:

Below is the abstract of the article.

Read the full article PDF by clicking here

or on the link below.

Purpose

Therapies that produce deep and durable responses in patients with metastatic melanoma are needed. This phase II cohort from the international, single-arm PIVOT-02 study evaluated the CD122-preferential interleukin-2 pathway agonist bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in first-line metastatic melanoma.

Methods

A total of 41 previously untreated patients with stage III/IV melanoma received BEMPEG 0.006 mg/kg plus NIVO 360 mg once every 3 weeks for ≤ 2 years; 38 were efficacy-evaluable (≥ 1 postbaseline scan). Primary end points were safety and objective response rate (blinded independent central review); other end points included progression-free survival, overall survival (OS), and exploratory biomarkers.

Results

At 29.0 months' median follow-up, the objective response rate was 52.6% (20 of 38 patients), and the complete response rate was 34.2% (13 of 38 patients). Median change in size of target lesions from baseline was −78.5% (response-evaluable population); 47.4% (18 of 38 patients) experienced complete clearance of target lesions. Median progression-free survival was 30.9 months (95% CI, 5.3 to not estimable). Median OS was not reached; the 24-month OS rate was 77.0% (95% CI, 60.4 to 87.3). Grade 3 and 4 treatment-related and immune-mediated adverse events occurred in 17.1% (7 of 41) and 4.9% (2 of 41) of patients, respectively. Increased polyfunctional responses in CD8+ and CD4+ T cells were seen in blood after treatment, driven by cytokines with effector functions. Early on-treatment blood biomarkers (CD8+ polyfunctional strength difference and eosinophils) correlated with treatment response.

Conclusion

BEMPEG in combination with NIVO was tolerated, with relatively low rates of grade 3 and 4 treatment-related and immune-mediated adverse events. The combination had encouraging antitumor activity in first-line metastatic melanoma, including an extended median progression-free survival. Exploratory analyses associated noninvasive, on-treatment biomarkers with response, before radiologic evidence was observed.

Read an interview about the study here and expert commentary about the clinical implications here.

Read the full article

Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma

Primary Source

Journal of Clinical Oncology

Source Reference:

口袋女优