A phase II study of intravenous (IV) milataxel (M) for the treatment of non-small cell lung cancer (NSCLC) refractory to platinum-based therapy

7098 Background: M (TL139, MAC-321) is a novel taxane that has shown activity when administered IV or orally in both taxane-resistant and susceptible nude mouse xenograft models. The current study is an open-label study in previously treated patients (pts) with locally advanced, metastatic, or recurrent NSCLC to determine response rate. Methods: Pts with cytologically or histologically confirmed NSCLC must have received 1 or 2 prior regimens including prior platinum, and may have received prior paclitaxel or docetaxel. Good performance status (ECOG 0 or 1), and adequate hematologic, hepatic and renal function were required. Pts with clinically active brain metastases were excluded. Pts were treated with M 35 mg/m 2 as a 4 hr IV infusion every 3 weeks. The primary end point was objective response rate. Results: A total of 46 pts were treated: 21 (46%) female pts and 25 (54%) male pts. Mean age was 59 (range 41–85), ECOG was PS 0 in 13 (28%) pts, PS 1 in 31 (67%) pts and unknown in 2 (4%) pts. The number of prior chemotherapy regimens was > 1 in 21 (46%) pts. Twenty-five (54%) pts had one prior taxane and 7 (15%) pts had both paclitaxel and docetaxel previously. The median number of cycles was 3 (range 1–14). Nine (20%) pts required dose reduction. Five (11%) pts discontinued treatment due to adverse events. A total of 25 (54%) pts reported drug related grade 3 or 4 adverse events. Non-hematologic grade 3 or 4 drug-related events occurring in more than 1 pt included: neuropathy 4 (9%) pts, neutropenic fever 3 (7%) pts, arthralgia 2 (4%) pts. There was no treatment related mortality. Objective responses were confirmed in 4 (9%) pts (3 PR, 1 CR). Three pts with response (including pt with CR) had received prior docetaxel. PR duration was 175, 250, and 315 days. Pt with CR received 4 cycles of M and discontinued due to the CR. Pt remained in CR at day 504. Conclusions: Milataxel 35 mg/m 2 as a 4 hr IV infusion every 3 weeks provided durable responses in heavily pretreated pts including pts who had previously received taxanes. No significant financial relationships to disclose.