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T. Tamura
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MINI 03 - PD1 Axis Inhibition and EGFR (ID 101)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Gandhi, Y. Ohe
- Coordinates: 9/07/2015, 16:45 - 18:15, Four Seasons Ballroom F1+F2
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MINI03.06 - Phase II Studies of Nivolumab in Patients with Advanced Squamous (SQ) or Non-Squamous (NSQ) Non-Small-Cell Lung Cancer (NSCLC) (ID 1329)
16:45 - 18:15 | Author(s): T. Tamura
- Abstract
- Presentation
Background:
Nivolumab (anti-PD-1, ONO-4538, BMS-936558), a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in previous[MS誠1] phase I and II trials in several tumor types. In March 2015, U.S. Food and Drug Administration (FDA) has approved Nivolumab for the treatment of patients with metastatic squamous (SQ) non-small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Here, we report the results of two phase II studies to evaluate the efficacy and safety of nivolumab in previously treated advanced SQ (JapicCTI-No.132072) and NSQ (JapicCTI-No.132073) NSCLC pts.
Methods:
Both studies required pts aged ≥ 20 years with an ECOG performance status of 0 or 1, stage IIIB/IV, or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen. Pts received nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity. The primary endpoint in both studies was the objective response rate (ORR) (RECIST v1.1). Planned sample size was 30 pts for SQ and 67 pts for NSQ, respectively (P~0~[MS誠1] =0.09 &[MS誠2] P~1~=0.26, P~0~=0.09 & P~1~=0.20 ; α=0.025 (one-side), 1-β=0.8).
Results:
From April 2013 to April 2014, a total of 111 NSCLC pts were enrolled in both studies (35 pts with SQ, 76 pts with NSQ, male/female: 81/30; PS 0/1: 46/55; aged 31 to 84 [median: 65.0] years; Stage IIIB/Stage IV/recurrence: 6/86/19). Objective response rates (ORRs) were 25.7% (9/35) [95% CI: 14.2, 42.1] in SQ and 19.7% (15/76) [95% CI: 12.3, 30.0] in NSQ, respectively. Complete Response was observed in 2.6% with NSQ. Median progression-free survival (mPFS) was 4.2 months (95% CI: 1.4, 7.1) for SQ and 2.8 months (95% CI: 1.4, 3.4) for NSQ, respectively. Median follow-up periods were 10.4 months and 8.4 months, respectively. Median duration of response was not reached in each study. Of 9 SQ pts and 15 NSQ pts who responded to nivolumab, durable and ongoing response was observed in 77.8% (7/9) and 80.0% (12/15), respectively. Median overall survival was not reached in either study. All Grade drug-related adverse events across both studies were 79.3% (88/111) and Grade 3-4 drug-related adverse events (G3-4 AEs) were observed in 16.2% (18/111) pts. Most common G3-4 AEs were lymphocyte count decreased 3.6% (4/111), hyponatremia 1.8% (2/111), interstitial lung disease 1.8% (2/111), pleural effusion 1.8% (2/111). Any grade of interstitial lung disease was observed in 4.5% (5/111) pts. No grade 5 AEs were observed.
Conclusion:
In these studies, nivolumab showed encouraging clinical efficacy in both SQ and NSQ NSCLC with a manageable safety profile.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-020 - Updated Data from JP28927 Study of Alectinib in ALK+ NSCLC Patients with or without History of ALK Inhibitor Treatment (ID 346)
09:30 - 17:00 | Author(s): T. Tamura
- Abstract
Background:
Alectinib, a next generation ALK inhibitor, was granted approval in Japan 2014, since it showed good efficacy and tolerability in ALK+ NSCLC patients without previous ALK inhibitor treatment in Phase I/II study (AF-001JP). We also reported its promising response and good tolerability for crizotinib pre-treated patients in JP28927 study (ESMO 2014). This report describes the update of efficacy and safety result in JP28927 study.
Methods:
Patients (with/without prior ALK inhibitor treatment) who had ALK+ NSCLC were enrolled in JP28927. Patients received alectinib (300mg) twice daily; treatment was continued until the investigator determined lack of clinical benefit.
Results:
Thirty-five patients were enrolled into JP28927 study. Median follow-up duration was 400 days (35-457 days). The median progression free survival (PFS) of 35 patients was 13.9 months (95%CI: 11.1- NR). Among 30 patients with the target lesions at base line, the overall response rate (ORR) was 70% (95%CI: 50.6-85.3) with rapid response (the median time to response was 1.2 months [95%CI: 1.1-2.1]). Twenty-three out of 35 patients had been confirmed the progressive disease with crizotinib treatment. Their median PFS was 12.9 months (95%CI: 3.9-NR). Twenty out of 23 patients had the target lesions at base line. ORR was 65% (95%CI: 40.8-84.6) and the median time to response was 1.2 months (95%CI: 1.1-1.3). The treatment-related adverse events (AEs) observed in more than 10% of the patients were constipation (31.4%), dysgeusia (25.7%), WBC count decreased (22.9%), neutrophil count decreased (22.9%), vomiting (14.3%), rash (14.3%), blood bilirubin increased (14.3%) and AST increase (14.3%). Treatment-related Grade 3 AEs, i.e. pulmonary thrombosis, lymphocyte count decrease, hypophosphatemia, were observed in 3 patients. No treatment-related Grade 4 or 5 AEs were observed.
Conclusion:
The updated results in JP28927 study once again endorsed our previous reports which had indicated alectinib’s promising response even for ALK+NSCLC patients who failed to crizotinib treatment.
