Multicenter Randomized Open-Label Phase II Clinical Study Comparing Outcomes of NK105 and Paclitaxel in Advanced or...

Area of Science:

• Oncology
• Nanomedicine
• Pharmacology

Background:

• NK105 is a novel core-shell polymeric micellar nanoparticle formulation incorporating paclitaxel (PTX).
• Efficacy and safety of NK105 versus paclitaxel at equivalent doses in advanced or recurrent breast cancer were previously uncompared.

Purpose of the Study:

• To compare the efficacy and safety of NK105 and paclitaxel in patients with advanced or recurrent breast cancer at equivalent dose levels.

Main Methods:

• A randomized study assigned 123 patients (62 to NK105, 61 to PTX) 1:1 ratio.
• Both drugs were administered at 80 mg/m² on Days 1, 8, and 15 of a 28-day cycle.
• Primary endpoint was overall response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events.

Main Results:

• No significant differences were observed in ORR (NK105: 41.9%, PTX: 45.9%), median PFS (9.1 vs. 7.8 months), or median OS (27.5 vs. 32.4 months).
• Neutropenia was more frequent with NK105, but manageable without frequent G-CSF or dose reduction.
• NK105 showed a significantly longer median time to onset of peripheral sensory neuropathy (PSN), with no Grade 3 or higher PSN observed.

Conclusions:

• Weekly NK105 administration is well-tolerated and demonstrates comparable efficacy to paclitaxel in advanced breast cancer.
• NK105 offers an improved safety profile, particularly a reduced incidence and delayed onset of peripheral sensory neuropathy.