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Grace K Dy
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P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.04-26 - Interim Results from a Phase I/II Trial of Nivolumab in Combination with CIMAvax-EGF as Second-Line Therapy in Advanced NSCLC (ID 13359)
16:45 - 18:00 | Presenting Author(s): Grace K Dy
- Abstract
Background
CIMAvax-EGF (CE), a recombinant anti-human epidermal growth factor (EGF) vaccine, has demonstrated survival benefit as maintenance therapy in advanced NSCLC. We report the results from the dose-escalation phase I portion of the study investigating CE in combination with Nivolumab(N) in patients (pts) with advanced stage, previously treated immunotherapy-naïve NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
This is an open-label phase I dose-escalation study with a 3+3 design. Intramuscular CE is investigated in two dose levels (1.2 and 2.4 mg, given q 2 weeks x 4 doses during the induction phase, then q monthly during the maintenance phase) in combination with 240 mg iv N q 2 weeks. Pts remain on treatment until disease progression, serious toxicity or consent withdrawal. The primary objective is to determine the safety and recommended phase II dose (RP2D) of CE in combination with N. Secondary objectives include tumor response and correlative markers of immune response. Toxicities are graded according to CTCAE v4.03. No intra-pt dose escalation is allowed
4c3880bb027f159e801041b1021e88e8 Result
9 pts have completed DLT assessments (7Female: 2Male). Median age is 58 (range 46-69). All pts have EGFR, KRAS and ALK wildtype NSCLC. Adenocarcinoma is the predominant histologic subtype (7/9). One pt had Gr 3 myocarditis (LVEF 25%-30%) attributed to N alone on Cycle 1 day 8 and taken off study. LVEF improved (60%-65%) but pt eventually had Gr 5 brain hemorrhage due to brain metastasis, unrelated to treatment, on Cycle 1 day 29. No other treatment-related CTC grade 3+ AEs attributed to either N and/or CE. The RP2D dose was established at 2.4 mg for CE. Objective response rate of 44% was seen (4 PRs: 3 adenocarcinoma, 1 squamous; 3 PD-L1 <1%, 1 PD-L1 60%). There is a significant inverse correlation (p<0.001) between the temporal change in anti-EGF Ab titers and the change in serum EGF levels based upon a generalized linear model. 71% of pts (95% CI 36%-92%) achieved an anti-EGF Ab titer of > 1:4000 after 3 vaccine doses by day 43. We will present additional information on safety, efficacy profile and correlative data in the meeting
8eea62084ca7e541d918e823422bd82e Conclusion
Combination of N+CE did not show unexpected toxicities. Preliminary efficacy and immunological data warrant further investigation.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.15-24 - Comparison of Pemetrexed Administered q 3 Weeks vs q 4 Weeks as Maintenance Therapy in NSCLC: Analysis of Real World Data from a Single Institution (ID 13057)
16:45 - 18:00 | Author(s): Grace K Dy
- Abstract
Background
Pemetrexed maintenance q 3 weeks has shown survival benefit in patients with advanced stage nonsquamous NSCLC. We sought to compare treatment outcomes in patients receiving alternate maintenance schedule ( q 4 weeks) in real-world practice.
a9ded1e5ce5d75814730bb4caaf49419 Method
This is a single-center, IRB-approved retrospective study of over 500 advanced stage (IIIB&IV) nonsquamous NSCLC patients receiving pemetrexed between May 1, 2011 to June 30, 2016 as standard of care. Patients who received at least two doses of maintenance pemetrexed were included in the analysis. Tumor response was assessed with CT scan imaging every 6-9 weeks. Hematologic indices, hepatic, renal function, performance status, dose changes, subsequent dosing or schedule changes, duration on therapy (discontinuation due to toxicity, switch in therapy or death) and overall survival data were obtained. Summary statistical analyses are provided for the demographic features of the patients included in this study in both. The difference between the two groups are evaluated using Fisher's Test /Chi-Square Test / Logistic regression analyses for categorical variable, and T-Test / Generalized Linear regression analyses for continuous variables. Generalized Linear regression model are applied to compare outcomes between outcomes SAS version 9.4 (SAS Institute, Cary, NC) will be used for statistical analyses. All tests were two-sided and performed at a nominal significance level of 0.05.
4c3880bb027f159e801041b1021e88e8 Result
138 patients were eligible to be included in the analysis. There were 90 and 48 patients who received pemetrexed q 3 weeks (group A) and q 4 weeks (group B), respectively. There were no differences in gender or ECOG performance status (PS) at baseline between the groups. Most common reasons documented for q4 week schedule are either patient preference or cumulative toxicities (lab abnormalities, poor tolerance or fatigue after induction treatment). Duration on therapy was longer in group B than in group A (282 days vs 156 days, p < 0.001). There were no differences in pre- and post-treatment changes in hemoglobin, ANC, creatinine clearance, ALT or AST levels between the two groups. There was also no difference in the change in PS between groups. Platelet count was higher at the end of therapy in group A compared to group B (p<0.01) . Survival outcomes and molecular profiling data will be presented in the meeting.
8eea62084ca7e541d918e823422bd82e Conclusion
Alternate q 4 week dosing schedule of pemetrexed is feasible and associated with longer time on treatment. There appears to be no difference in toxicities experienced between the two treatment schedules in this cohort.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-86 - Treatment Outcomes with Reduced Frequency of Nivolumab Dosing as Second-Line Therapy in Patients with Advanced NSCLC (ID 12784)
12:00 - 13:30 | Author(s): Grace K Dy
- Abstract
Background
Nivolumab (Nivo) was approved as second-line therapy in 2015 for patients (pts) with advanced NSCLC. The optimal effective interval between doses is not well-established. We want to evaluate the effect of reduced dose density on the efficacy and safety of Nivolumab.
a9ded1e5ce5d75814730bb4caaf49419 Method
This is a single-institution, IRB approved retrospective review of stage IIIB/IV NSCLC who received Nivo after prior platinum-based chemotherapy in the second line setting or beyond between April 2015-January 2018. Characteristics of pts who received Nivo 240mg every(q) 4 weeks or longer, reasons for alternate dosing and their treatment outcomes are described.
4c3880bb027f159e801041b1021e88e8 Result
Out of 181 pts with NSCLC who received Nivo during this time frame, 32 pts (18Male:14 Female) received an alternate dosing schedule (median q 4 weeks, range q 3-12 weeks). Median age was 65 years. Majority were former smokers (62%) and had adenocarcinoma (81%). 17 pts started on a regular schedule q 2 weeks and then switched to an alternate schedule, the remaining 15 pts started on an alternate schedule. 28% (9/32) patients were on an alternate schedule due to adverse event. Median expected total cumulative dose (240mg*no. of expected doses until disease progression or death) per pt is 4032mg (range 480 -15840). Median actual cumulative dose (240mg*actual no. of doses) received per pt is 1920mg (range 480 - 10560). This represents a median of 52% of the expected total cumulative dose received. Objective response rate (CR+PR) in the entire cohort was 66%. Median progression-free survival(PFS) from start of alternate schedule is 17.1 months (95% CI 5.2- not reached). 6-month PFS is 65% (95% CI 46%-79%) starting from when alternate schedule of Nivo was begun. We will present updated toxicity and treatment outcomes in the meeting.
8eea62084ca7e541d918e823422bd82e Conclusion
Nivolumab 240mg administered at q 4 weeks or longer is feasible. Further investigation is needed to optimize patient selection for alternate dosing schedule.
6f8b794f3246b0c1e1780bb4d4d5dc53
