Abstract 1038P
Background
Nanosomal docetaxel lipid suspension (NDLS) was developed to overcome toxicity issues associated with conventional docetaxel. Conventional docetaxel carries a boxed warning of increased mortality with 100 mg/m2 dose in non-small cell lung cancer (NSCLC). We evaluated the efficacy and safety of NDLS monotherapy in patients with locally advanced (LA)/non-resectable/metastatic NSCLC after failure of prior platinum-based chemotherapy.
Methods
In this two arm, randomized, multicentric, open label study, advanced NSCLC patients received NDLS 75 (T1 arm) or 100 mg/m2 (T2 arm) every 3 weeks for 6 cycles. Steroid premedication was not mandatory but could be administered as per institutional practice. Patients could be administered filgrastim support. Overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety were evaluated.
Results
Of 80 patients enrolled (T1: 39; T2: 41), 60 qualified as modified intent-to-treat (mITT) population (T1: 34; T2: 26). In the T1 and T2 arms, the ORRs were 2.9% and 15.4%, respectively (Table). At 1-year follow-up, median PFS in T1 and T2 arms was 8.07 and 8.13 months, respectively. The OS and PFS for both arms were 98.3% and 31.5%, respectively, at 1-year. The median OS was not reached for both arms. Most patients did not require steroid premedication. Anemia, leukopenia, abdominal pain, diarrhea, vomiting, asthenia, pyrexia, and anorexia were commonly reported (≥10% patients) adverse events. Only 2 events of grade 3 neutropenia (1 in each arm) were observed. Grade 3/4 hyperglycemia, infusion-related reactions, or neuropathy were not reported. No new safety concerns were observed. Table: 1038P
Response rate
| Parameter | mITT (N=60) | |
| NDLS 75 mg/m2 (n=34) | NDLS 100 mg/m2 (n=26) | |
| CR, n (%) | 0 (0.0) | 0 (0.0) |
| PR, n (%) | 1 (2.9) | 4 (15.4) |
| SD, n (%) | 26 (76.5) | 18 (69.2) |
| ORR, n (%), [95% CI] | 1 (2.9) [0.07-15.33] | 4 (15.4) [4.36-34.87] |
| DCR, n (%), [95% CI] | 27 (79.4) [62.10-91.30] | 21 (80.8) [60.65-93.45] |
Conclusions
NDLS monotherapy (75 or 100 mg/m2) was effective and well-tolerated in the treatment of advanced NSCLC. NDLS demonstrated a dose dependent increase in efficacy from 75 to 100 mg/m2.
Clinical trial identification
Editorial acknowledgement
Mr. Shreekant Sharma (CMPPTM ISMPP, Intas Pharmaceuticals Limited, Ahmedabad, India) provided medical writing assistance for this study.
Legal entity responsible for the study
Lambda Therapeutic Research Limited.
Funding
Intas Pharmaceuticals Limited.
Disclosure
C. Deshmukh, G. Biswas, A.B. Patel, R. Naik, S. Belagutti Jayappa, L.C. Kuntegowdanahalli, N. Khippal, R. Nagarkar, G. Mamillapalli, V.K. Mahobia, S. Bondarde, J.G. Patel: Financial Interests, Institutional, Principal Investigator: Intas Pharmaceuticals Limited. A. Ahmad, S. Sheikh, S.M. Ali, I. Ahmad: Financial Interests, Institutional, Full or part-time Employment: Jina Pharmaceuticals; Financial Interests, Institutional, Sponsor/Funding: Jina Pharmaceuticals. M. Paithankar, A. Rajani, D. Bunger, M.A. Khan: Financial Interests, Institutional, Full or part-time Employment: Intas Pharmaceuticals Limited; Financial Interests, Institutional, Sponsor/Funding: Intas Pharmaceuticals Limited.