New Data Supports Abraxane in Non-Small Cell Lung Cancer

Interim data from the ABOUND trials further supports the safety, efficacy, and tolerability of nab-paclitaxel (Abraxane) in patients with advanced non-small cell lung cancer (NSCLC).

ABOUND is a multi-phase, open-label, multicenter, clinical trial 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 NSCLC.

The findings, which were presented at the IASLC 17^th World Conference on Lung Cancer, reinforce the benefit of Abraxane/carboplatin doublet therapy in first-line NSCLC, according to a press release.

The results of the interim ABOUND.70+ included 128 patients 70 years and older administered first-line treatment with Abraxane/carboplatin for advanced NSCLC found that 79% of patients experienced grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression.

At the time of the analyses, the medial overall survival was 14.6 months, and the median progression-free survival was 6.2 months, gathered across the 2 treatment arms.

The study participants were randomized to receive first-line treatment with Abraxane/carboplatin, either continuous weekly or weekly every 3 weeks with a 1-week break. Overall, 80% of patients discontinued treatment, with 24% stopping due to adverse events and 34% because of disease progression.

Grade ≥2 PN was reported in 34% of patients, while grade ≥3 neutropenia, anemia, and thrombocytopenia was observed in 52%, 21% and 21% of patients, respectively.

For the interim ABOUND.sqm trial, 284 patients administered first-line induction treatment with Abraxane/carboplatin for stage 3B/4 squamous NSCLC showed that the safety profile was consistent with data previously reported for the squamous subset in the pivotal phase 3 trial, according to the press release.

During the induction phase, all patients were given four 21-day cycles of standard Abraxane/carboplatin. Overall, 119 patients discontinued treatment during the induction phase. Thirty-four percent of patients discontinued treatment due to disease progression, and 24% stopped treatment due to adverse events. The most common grade 3/4 treatment emergent adverse events were hematologic, including neutropenia, anemia, and thrombocytopenia.

Both of the ABOUND trials also evaluated patient quality-of-life using the Lung Cancer Symptom 3-item Index Scale (LCSS), Symptom Burden Index, Lung Cancer Symptom and Pulmonary Symptom Scores and the EuroQol 5-dimensions, 5-level questionnaire.

The analyses suggest that quality-of-life was generally maintained or improved in both patient populations, according to the press release.

“These early data from the ABOUND clinical trial program are very encouraging, as they are consistent with the findings related to these hard-to-treat non-small cell lung cancer patient subgroups seen in the pivotal Abraxane phase 3 trial,” said Michael Pehl, president, Hematology and Oncology for Celgene. “These data, coupled with the ongoing studies of Abraxane in combination with novel agents and immunotherapies, provide us with a deeper understanding of how to treat challenging patient populations and will help us to continue to develop future treatment options.”

Interim results of a phase 1 study of nivolumab in combination with Abraxane/carboplatin in 22 patients with stage 3B/4 NSCLC will also be presented at the WCLC.