Interim results from the ABOUND clinical trial program of Abraxane (paclitaxel protein-bound particles for injectable suspension) for advanced NSCLC. - Celgene

Celgene Corporation announced interim results from the ABOUND clinical trial program evaluating the use of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with advanced non-small cell lung cancer (NSCLC). Interim data being presented from the ABOUND trials during the IASLC 17th World Conference on Lung Cancer (WCLC) reinforces the benefit of Abraxane/carboplatin doublet therapy in first-line NSCLC.

Interim ABOUND.70+ data in 128 elderly patients (more than 70 years old) receiving first-line treatment with Abraxane/carboplatin for advanced NSCLC found that 91 (73%) patients experienced grade more than 2 peripheral neuropathy (PN) or grade more than 3 myelosuppression [primary endpoint]. At the time of the analyses, the median overall survival was 14.6 months and the median progression-free survival was 6.2 months, pooled across the two treatment arms [secondary endpoints]. Patients were randomized to receive first-line treatment with Abraxane/carboplatin either continuous weekly or weekly every three weeks with a one-week break. Overall, 80 percent of patients discontinued treatment and the majority did so due to adverse events (24 percent) or disease progression (34 percent). Grade more than 2 PN was reported in 34% of patients, and grade more than 3 neutropenia, anemia, and thrombocytopenia was observed in 52%, 21% and 21% of patients, respectively.

The interim ABOUND.sqm data in 284 patients receiving first-line induction treatment with Abraxane/carboplatin for stage IIIB/IV squamous NSCLC showed that the safety profile was consistent with that previously reported for the squamous subset in the pivotal Phase III trial. During the induction phase, all patients received four 21-day cycles of standard ABRAXANE/carboplatin therapy. Overall, 119 patients (42 percent) discontinued treatment during the induction phase. The majority of patients discontinued treatment due to disease progression (34 percent) or adverse events (24 percent). The most common grade 3/4 treatment emergent adverse events (TEAEs) were hematologic and included anemia (26 percent), neutropenia (43 percent) and thrombocytopenia (15 percent). Both ABOUND trials also evaluated quality of life utilizing the Lung Cancer Symptom 3-item index Scale (LCSS), Symptom Burden Index, Lung Cancer Symptom and Pulmonary Symptom Scores and the EuroQol five dimensions, five level questionnaire (EQ-5D-5L). These interim analyses suggest that quality of life was generally maintained or improved in both patient populations.

ABOUND is a multi-phase, open-label, multicenter clinical trial program evaluating the use of Abraxane in combination with carboplatin or other novel agents, including immunotherapy, as first- or second-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The ABOUND trials included patients 70 years and older, as well as those with poorer performance status or squamous disease and those receiving second-line+ treatment.