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Luciano Wannesson
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P1.12 - Small Cell Lung Cancer/NET (ID 179)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.12-03 - Antitumor Activity of Single Agent Lurbinectedin in Patients with Relapsed SCLC Occurring ≥30 Days After Last Platinum Dose (ID 1710)
09:45 - 18:00 | Author(s): Luciano Wannesson
- Abstract
Background
Lurbinectedin (L) inhibits activated transcription and induces DNA double-strand breaks, leading to apoptosis.
Method
This multicenter, single agent, phase II Basket trial treated a cohort of 105 SCLC patients (pts) with ECOG PS 0-2 who had received one prior chemotherapy line. L 3.2 mg/m2 was administered as a 1-hour i.v. infusion on Day 1 q3wk. Primary endpoint, confirmed overall response rate (ORR) by RECIST v.1.1 according to investigator assessment, was met (ORR=35.2%; 95% CI, 26.2-45.2%). A sub-analysis excluding the 21 pts with disease relapse < 30 days after last platinum dose is reported here.
Result
Median age of 84 evaluated pts was 60 years (range, 41-83), 58.3% were male, ECOG PS 0-1/2 in 96/4%, liver metastasis in 36.9%, history of CNS involvement in 4.8%, prior platinum in 100%, median chemotherapy-free interval (CTFI)=3.9 months (1.1-16.1); prior immunotherapy in 8.3%. A median of 5.5 cycles (range, 1-24) was administered.
ORR, % (95% CI) (confirmed responses) (n=84)
40.5 (29.9-51.7)*
CTFI≥90d (n=60)
45.0 (32.1-58.4)
CTFI 30-89d (n=24)
29.2 (12.6-51.1)
Disease Control Rate at 6 months, % (n=84)
48.8
Median duration of response (months) (95% CI) (n=34)
5.3 (3.5-6.4)
CTFI≥90d (n=27)
6.2 (3.5-7.3)
CTFI 30-89d (n=7)
4.1 (2.6-5.3)
Median overall survival (months) (95% CI) (n=84)**
10.9 (7.8-14.9)
CTFI≥90d (n=60)**
11.9 (9.7-16.2)
CTFI 30-89d (n=24)**
(4.1-7.6)
*4 of 7 pts who failed prior immunotherapy had confirmed response
**Preliminary data
L was well tolerated. Neutropenia was the most common adverse event (AE) (G3:21.5% and G4:25%), whereas febrile neutropenia was reported in 2.4%. Most common non-hematological AEs included fatigue (G3: 7.1%), nausea and vomiting (all G1-2: 32.1% and 16.7%) and transaminase increase (G3:7.2%). There was no death due to treatment related AE.
Conclusion
L is an active agent for second-line treatment of SCLC. The highest ORR (45.0%) was reported for pts with CTFI≥90d. Notable antitumor activity (ORR=29.2%) was also observed in pts with CTFI 30-89d, for whom no therapy is currently approved. Hence, L is a valuable therapeutic option for SCLC pts with disease relapse after first-line platinum-based therapy.
Updated trial results will be presented at the conference.
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P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.12-21 - Outcomes with Immune Checkpoint Inhibitors (ICI) for Relapsed Small Cell Lung Cancer (SCLC) in a Swiss Cohort (ID 1026)
10:15 - 18:15 | Author(s): Luciano Wannesson
- Abstract
Background
Chemotherapy for relapsed small-cell lung cancer (SCLC) has limited activity. Results from early clinical trials showed promising outcomes in a subset of patients with relapsed SCLC receiving ICI. Therefore, nivolumab +/- ipilimumab, pembrolizumab or atezolizumab have been used off-label in Switzerland.
Method
9 cancer centers in Switzerland contributed data to this retrospective cohort of patients who received off-label ICI for relapsed SCLC. Patient characteristics including age, smoking status, stage at diagnosis and previous treatments were collected. Outcomes of ICI were assessed by the local investigators using standard RECIST v1.1 criteria. Tumor tissues were assessed centrally for PD-L1 expression, tumor mutational burden and immune-related gene expression signatures.
Result
45 patients were included between November 2016 and January 2019. Median age was 63 years. 73% were males, 4% never smokers and 18% had a performance status (PS) ≥2. ICIs were given as second line treatment in 24 patients (53%). 24 patients (53%) received combination immunotherapy with ipiliumumab and nivolumab. 28 patients (62%) had undergone tumor irradiation (RT) prior to or during ICI. In the entire population, the overall response rate was 31%, while 49% had progressive disease as best response. Median progression-free survival was 2.5 months and median overall survival 6.5 months. There was no significant association between type of ICI (mono vs. combo) or prior RT vs. no RT with survival outcomes in a multivariate analysis. There were no new safety signals. One patient died of immune-related pneumonitis.
Conclusion
This is the first report of “real-world” data on ICI in relapsed SCLC also including patients with poor PS. We confirm the efficacy and safety of ICI in relapsed SCLC as previously shown in clinical trials. No clinical prognostic marker could be identified. Results on the prognostic value of tissue-based biomarkers will be presented at the meeting.
