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P. Bushunow
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-001 - A Phase II Study of Etirinotecan Pegol (NKTR-102), a Topoisomerase-l lnhibitor Polymer Conjugate, in Small Cell Lung Cancer (ID 4349)
14:30 - 14:30 | Author(s): P. Bushunow
- Abstract
Background:
Small cell lung cancer (SCLC) has poor prognosis and systemic chemotherapy is the standard treatment. Irinotecan is a topoisomerase-I inhibitor that has been used in treating SCLC. Etirinotecan pegol (NKTR-102) is a polyethylene glycol conjugate of irinotecan. It is a next generation topoisomerase-I inhibitor uniquely designed for prolonged tumor cell exposure by using the polymer conjugate technology. This is a single arm phase II study to evaluate single agent etirinotecan pegol in patients with relapsed SCLC (NCT01876446).
Methods:
A total of 38 patients who have received only one prior systemic therapy for SCLC are being accrued over 3 years. There are 2 patient cohorts: those progressing on first-line chemotherapy <3 months after completion of treatment (Group A: chemotherapy-resistant, N=20) and those progressing on first-line chemotherapy ≥3 months after completion of treatment (Group B: chemotherapy-sensitive, N=18). Etirinotecan pegol was administered at 145 mg/m[2] IV once every 3 weeks. Cycles were repeated every 21 days until disease progression, unacceptable toxicity, or withdrawal from study. The primary endpoint is the 18-week progression free survival (PFS) rate. The secondary endpoints are objective response rate (ORR), duration of response (DOR), overall survival (OS) and toxicity. A single-stage design is used to assess the primary endpoint separately for each patient group.
Results:
Accrual of Group A is ongoing. Group B has completed targeted enrollment of 18 patients and the results are presented here. Median age was 61.6 (50-76.5) years, with 50% male. Prior chemotherapy included cisplatin/etoposide (41.2%) and carboplatin/etoposide (58.8%). Patients received a median of 6 (1-30) cycles of etirinotecan pegol, with dose reduction in 22.2%. PFS rate at week 18 was 72.2% (13/18, 95% Confidence Interval (CI): 47-90%). ORR was 44.5% (8/18), including one complete response. Another one-third (6/18) of patients had stable disease. Median DOR was 4 (1.4-14.5) months. Median PFS was 21.9 (95% CI: 11.7, 29.3) weeks, and OS was 7.1 (95% CI: 4.8, 14.7) months. The most common treatment-related adverse events (AEs) of any grade were diarrhea (66.7%), nausea (55.6%), fatigue (38.9%), and vomiting (27.8%). Neutropenia occurred in 2 cases, both grade 2, without neutropenic fever. The most common AEs ≥grade 3 were lymphopenia, hyponatremia and muscular weakness (2 cases each, all grade 3).
Conclusion:
Etirinotecan pegol has shown promising activity with acceptable toxicity profile in treatment of chemotherapy-sensitive patients with relapsed SCLC. Accrual of chemotherapy-resistant patients is expected to be completed soon.
