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Maria Pilar Lopez-Criado
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MA04 - Novel Approaches with IO (ID 900)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Immunooncology
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 107
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MA04.01 - Cemiplimab, a Human Monoclonal Anti-PD-1, Alone or in Combination with Radiotherapy: Phase 1 NSCLC Expansion Cohorts (ID 13177)
13:30 - 13:35 | Author(s): Maria Pilar Lopez-Criado
- Abstract
Background
Cemiplimab (REGN2810), a human monoclonal anti-PD-1, has exhibited substantial antitumor activities in patients with advanced malignancies in a first-in-human study. We report interim results of the Phase 1 expansion cohorts (ECs 1 and 2) of cemiplimab, alone or plus radiotherapy, in advanced NSCLC (NCT02383212).
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with advanced NSCLC who had relapsed after, or were refractory to, at least, first-line therapy received cemiplimab 200 mg Q2W in EC 1, or cemiplimab 3 mg/kg Q2W plus radiotherapy (9 Gy × 3 times/week 1 week after first dose of cemiplimab) to a single lesion in EC 2. For EC 2, patients were required to have NSCLC for which palliative radiation therapy was indicated. Planned treatment duration was up to 48 weeks in both ECs. The co-primary objectives were to evaluate the safety, tolerability, and efficacy of cemiplimab, alone or plus radiotherapy. Tumor measurements (of non-irradiated lesions) were performed by RECIST 1.1 Q8W.
4c3880bb027f159e801041b1021e88e8 Result
As of Sept 1, 2017, 20 patients (13 M/ 7 F; median age 64.0 years [range, 50–82]) and 33 patients (22 M/ 11 F; median age 67.0 years [range, 47–82]) were enrolled in EC 1 and EC 2, respectively. ECOG performance status 1 versus 0 was 80.0% versus 20.0% and 66.7% versus 30.3%, respectively, for ECs 1 and 2, and missing in one in EC 2; 75.0% (EC 1) and 48.5% (EC 2) had received prior radiotherapy. Investigator-assessed overall response rate (ORR; complete response [CR] + partial response [PR]) was 40.0% (1 CR and 7 PRs) and 18.2% (6 PRs) in EC 1 and EC 2, respectively. Disease control rate (ORR + stable disease [SD]) was 60.0% (1 CR + 7 PRs + 4 SDs) and 72.7% (6 PRs + 18 SDs) in EC 1 and EC 2, respectively. The most common treatment-emergent adverse events (TEAEs) of any grade were arthralgia, asthenia, cough, and dyspnea (each 20.0%) in EC 1, and decreased appetite (30.3%), fatigue (27.3%), cough (24.2%), asthenia and back pain (each 21.2%) in EC 2. Grade ≥3 TEAEs occurring in ≥2 patients were pneumonia (10.0%) in EC 1; and anemia (12.1%), hypophosphatemia and urinary tract infection (each 6.1%) in EC 2. One patient in EC 2 experienced TEAE of pneumonitis with an outcome of death, considered related to study drug.
8eea62084ca7e541d918e823422bd82e Conclusion
Cemiplimab monotherapy demonstrated substantial antitumor activity in pretreated NSCLC patients. The safety profiles were comparable with other anti-PD-1 agents and radiotherapy.
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P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.12-20 - Overall Survival with Lurbinectedin Plus Doxorubicin in Relapsed SCLC. Results from an Expansion Cohort of a Phase Ib Trial. (ID 13245)
16:45 - 18:00 | Author(s): Maria Pilar Lopez-Criado
- Abstract
Background
Lurbinectedin (PM01183, L) is a new anticancer drug that binds to DNA, inhibits transactivated transcription and modulates tumor microenvironment. Preclinical evidence of synergism was observed for PM01183 in combination with doxorubicin (DOX).
a9ded1e5ce5d75814730bb4caaf49419 Method
This multicenter, phase Ib clinical trial found impressive activity in second-line SCLC patients (ORR 67%). An expansion cohort with reduced dose (L 2mg/m2+ DOX 40mg/m2) was implemented to improve safety. SCLC patients <75 years with ECOG PS 0-1 and with no more than one prior chemotherapy line and stable brain metastases were included. DOX was interrupted after 10 cycles continuing with PM01183 alone. Primary G-CSF prophylaxis was not mandatory.
4c3880bb027f159e801041b1021e88e8 Result
27 patients treated. Males: 75%; median age: 64 (49-77) years; ECOG PS 0-1: 32%-68%; CNS involvement: 4%; bulky disease (>50 mm): 75%. 88% responded to 1st line (CR in 4%). Median chemotherapy-free interval (CTFI) was 3.5 months (m). 22% refractory (CTFI <30 days) 15% resistant (R) (CTFI 30-90 days) and 63% sensitive (S) (CTFI>90 days). Overall confirmed ORR was 37% (CR in 4%), and 53% (CR in 6%) in S patients. Overall median PFS was 3.4 m (95% CI, 1.5-6.2), being 1.5 m (95%CI, 0.8-3.4) in R pts, and 5.7 m in S patients. Overall survival (OS) data are summarized in the following table.
OS
Overall
Resistant
Sensitive
Overall (n=27)
7.9 m
(95% CI: 4.9-11.5)
4.9 m
(95% CI: 2.3-6.7)
11.5 m
(95% CI: 6.0-16.6)
Excluding CTFI<30days (n= 21)
10.2 m
(95% CI: 6.0-12.1)
6.7 m
(95% CI: 5.1-8.4)
11.5 m
(95% CI: 6.0-16.6)
Data shown are median and 95% CI.
Grade 4 neutropenia, anemia or thrombocytopenia appeared in 64%/0%/7% of patients, respectively, and febrile neutropenia (G3/4) occurred in 10%. Non-hematological toxicity was mild and mainly due to fatigue (G3=18%) and nausea (G3=7%).
8eea62084ca7e541d918e823422bd82e Conclusion
Lurbinectedin/DOX combination showed remarkable activity as second line in SCLC, especially in sensitive patients (CTFI>90 days). Activity is higher than that reported for CAV or topotecan. OS shows an outstanding improvement in this second-line setting, especially when excluding refractory pts. A phase III clinical trial (ATLANTIS, NCT02566993) is currently ongoing evaluating this combination in relapsed SCLC patients
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