ESMO Supporter 2018

Found 2 Presentations For Request "1247PD"

Poster Discussion session - Melanoma and other skin tumours Poster Discussion session

1247PD - Phase II multicenter, single arm, open label study of Nivolumab in combination with Ipilimumab in untreated patients with metastatic uveal melanoma. GEM1402.NCT02626962

Presentation Number
1247PD
Lecture Time
15:15 - 15:15
Speakers
  • Josep Maria Piulats Rodriguez (Barcelona, ES)
Location
ICM - Room 14b, ICM München, Munich, Germany
Date
20.10.2018
Time
14:45 - 16:05

Abstract

Background

Uveal melanoma (UM) accounts for 0.1% of cancer-related deaths. Liver disease is the most common finding. Life expectancy is reduced (<9 months) and chemotherapy seems not to improve overall survival (OS). Nivolumab plus ipilimumab (NIVO+IPI) has showed efficacy in metastatic skin melanoma, but to date no evidence on metastatic UM (MUM) is available.

Methods

GEM1402 is a phase-II, single-arm trial, leaded by the Spanish Melanoma Group (GEM) on NIVO+IPI in 50 untreated pts with MUM and ECOG-PS 0/1, recruited in 10 Spanish Sites. NIVO (1mg/kg, q3wk) and IPI (3mg/kg q3wk) were administered during 4 inductions, followed by NIVO (3mg/kg q2wk) until progressive disease (PD), toxicity or withdrawal. OS, progression free survival (PFS), overall response rate (ORR) per RECIST 1.1 (q6wk), and safety were evaluated. Intention to treat analysis includes pts with PD at first radiological evaluation. All pts receiving at least one dose of study treatment were evaluable for safety. Final data is disclosed.

Results

A total of 50 of 52 pts enrolled from April 2016 to May 2017 were analyzed. Median age 59 (26-84), 48% male, liver M1 in 76% pts, extra-liver M1 in 56% pts, 32% elevated LDH. 33 pts completed 2 cycles and 7 pts stopped after 1 dose (6 PD, 1 toxicity). Treatment-related adverse events were reported in 46 pts and treatment discontinuation in 9 pts. G ≥ 3 toxicities were reported in 27 pts (54%): transaminitis, dermatological, hepatitis, diarrhea, neurological, anemia, thyroiditis, hyperthyroidism, hypophysitis and hyponatremia. All G3/4 were resolved following the related guidelines. A G5 acute thyroiditis related to NIVO+IPI was reported. ORR was 6/50(12%)(95%CI 3-21), disease stabilization in 26/50(52%) and Disease Control Rate was 64% (95%CI 50.7-77.3). With a median follow-up of 7.06m, PFS was 3.27m. Median OS was 12.7 months.

Conclusions

Combination of NIVO+IPI is feasible in terms of efficacy and toxicity for MUM that merit further investigation.

Clinical trial identification

EudraCT:201500442915.

Legal entity responsible for the study

Grupo Español Multidisciplinar de Melanoma.

Funding

Bristol-Myers Squibb (BMS).

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion session - Melanoma and other skin tumours Poster Discussion session

Invited Discussant LBA47 and 1247PD

Lecture Time
15:15 - 15:25
Speakers
  • Georgina V. Long (North Sydney, AU)
Location
ICM - Room 14b, ICM München, Munich, Germany
Date
20.10.2018
Time
14:45 - 16:05